diff --git a/backend/debug-form-events.ts b/backend/debug-form-events.ts
new file mode 100644
index 00000000..f59dd55f
--- /dev/null
+++ b/backend/debug-form-events.ts
@@ -0,0 +1,175 @@
+/**
+ * 调试脚本：诊断表单和事件问题
+ * 
+ * 问题1：表单数量 - 应该是19个（含重复访视），但只识别7个
+ * 问题2：Age 为空 - 即使 Complete 状态，某些记录 age 仍为空
+ */
+import { PrismaClient } from '@prisma/client';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('🔍 表单和事件诊断');
+  console.log('='.repeat(60));
+
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+  });
+
+  if (!project) {
+    console.log('❌ 未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+
+  // ===============================
+  // 诊断 1：获取事件和表单映射
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 诊断 1：REDCap 事件和表单结构');
+  console.log('='.repeat(60));
+
+  // 获取事件列表
+  try {
+    const formData = new (await import('form-data')).default();
+    formData.append('token', project.redcapApiToken);
+    formData.append('content', 'event');
+    formData.append('format', 'json');
+
+    const axios = (await import('axios')).default;
+    const eventsResponse = await axios.post(`${project.redcapUrl}/api/`, formData, {
+      headers: formData.getHeaders()
+    });
+    
+    const events = eventsResponse.data;
+    console.log(`\n📋 事件列表 (共 ${events.length} 个):`);
+    for (const event of events) {
+      console.log(`  ${event.unique_event_name}: ${event.event_name}`);
+    }
+  } catch (error: any) {
+    console.log('  获取事件列表失败:', error.message);
+  }
+
+  // 获取表单-事件映射
+  try {
+    const formData = new (await import('form-data')).default();
+    formData.append('token', project.redcapApiToken);
+    formData.append('content', 'formEventMapping');
+    formData.append('format', 'json');
+
+    const axios = (await import('axios')).default;
+    const mappingResponse = await axios.post(`${project.redcapUrl}/api/`, formData, {
+      headers: formData.getHeaders()
+    });
+    
+    const mapping = mappingResponse.data;
+    console.log(`\n📋 表单-事件映射 (共 ${mapping.length} 个):`);
+    
+    // 按事件分组
+    const eventForms = new Map<string, string[]>();
+    for (const m of mapping) {
+      if (!eventForms.has(m.unique_event_name)) {
+        eventForms.set(m.unique_event_name, []);
+      }
+      eventForms.get(m.unique_event_name)!.push(m.form);
+    }
+
+    for (const [event, forms] of eventForms) {
+      console.log(`\n  📁 ${event}:`);
+      for (const form of forms) {
+        console.log(`     - ${form}`);
+      }
+    }
+
+    // 统计唯一表单
+    const uniqueForms = [...new Set(mapping.map((m: any) => m.form))];
+    console.log(`\n📊 统计:`);
+    console.log(`  唯一表单数: ${uniqueForms.length}`);
+    console.log(`  表单-事件映射总数: ${mapping.length}`);
+    console.log(`  这就是为什么显示19个而不是7个!`);
+
+  } catch (error: any) {
+    console.log('  获取表单-事件映射失败:', error.message);
+  }
+
+  // ===============================
+  // 诊断 2：检查 Record 4, 5, 14 的 age 问题
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 诊断 2：检查 age 为空的记录');
+  console.log('='.repeat(60));
+
+  const problemRecords = ['4', '5', '14'];
+  
+  for (const recId of problemRecords) {
+    console.log(`\n  === Record ${recId} ===`);
+    
+    // 获取原始数据（所有事件）
+    const rawRecords = await adapter.exportRecords({ records: [recId] });
+    console.log(`  原始记录数: ${rawRecords.length} (多事件)`);
+    
+    for (const r of rawRecords) {
+      const event = r.redcap_event_name || '(无事件)';
+      const age = r.age !== undefined && r.age !== '' ? r.age : '(空)';
+      const dob = r.date_of_birth || '(空)';
+      const formComplete = r.basic_demography_form_complete;
+      
+      console.log(`    事件: ${event}`);
+      console.log(`      age: ${age}, dob: ${dob}, form_complete: ${formComplete}`);
+    }
+
+    // 获取合并后数据
+    const merged = await adapter.getRecordById(recId);
+    console.log(`  合并后: age=${merged?.age || '(空)'}, dob=${merged?.date_of_birth || '(空)'}`);
+  }
+
+  // ===============================
+  // 诊断 3：检查 age 字段的元数据
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 诊断 3：age 字段的元数据');
+  console.log('='.repeat(60));
+
+  const calcFields = await adapter.getCalculatedFields();
+  const ageField = calcFields.find(f => f.fieldName === 'age');
+  
+  if (ageField) {
+    console.log(`\n  字段名: ${ageField.fieldName}`);
+    console.log(`  标签: ${ageField.fieldLabel}`);
+    console.log(`  表单: ${ageField.formName}`);
+    console.log(`  计算公式: ${ageField.calculation}`);
+  } else {
+    console.log('\n  ⚠️ 未找到 age 计算字段!');
+    
+    // 检查是否有其他年龄相关字段
+    const metadata = await adapter.exportMetadata();
+    const ageRelated = metadata.filter((f: any) => 
+      f.field_name.toLowerCase().includes('age') ||
+      f.field_label?.toLowerCase().includes('年龄')
+    );
+    
+    console.log(`\n  年龄相关字段:`);
+    for (const f of ageRelated) {
+      console.log(`    ${f.field_name} (${f.field_type}): ${f.field_label}`);
+      if (f.field_type === 'calc') {
+        console.log(`      公式: ${f.select_choices_or_calculations}`);
+      }
+    }
+  }
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ 诊断完成');
+  console.log('='.repeat(60));
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/backend/debug-qc-2.ts b/backend/debug-qc-2.ts
new file mode 100644
index 00000000..76b5a42f
--- /dev/null
+++ b/backend/debug-qc-2.ts
@@ -0,0 +1,71 @@
+/**
+ * 调试脚本：检查 REDCap 实际数据和字段映射
+ */
+import { PrismaClient } from '@prisma/client';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('=== 调试 REDCap 数据 ===\n');
+
+  // 1. 获取项目配置
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+    select: { 
+      id: true, 
+      name: true, 
+      redcapUrl: true, 
+      redcapApiToken: true,
+      fieldMappings: true 
+    }
+  });
+
+  if (!project) {
+    console.log('未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  console.log('项目:', { id: project.id, name: project.name });
+  console.log('字段映射配置:', JSON.stringify(project.fieldMappings, null, 2));
+
+  // 2. 从 REDCap 获取 record_id=1 的实际数据
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+  
+  try {
+    const record = await adapter.getRecordById('1');
+    console.log('\n=== REDCap Record ID=1 实际数据 ===');
+    console.log(JSON.stringify(record, null, 2));
+    
+    // 特别检查年龄相关字段
+    console.log('\n=== 年龄相关字段 ===');
+    const ageFields = Object.entries(record || {}).filter(([key]) => 
+      key.toLowerCase().includes('age') || 
+      key.toLowerCase().includes('年龄') ||
+      key.toLowerCase().includes('birth') ||
+      key.toLowerCase().includes('出生')
+    );
+    console.log('年龄相关字段:', ageFields);
+
+    // 显示所有字段名
+    console.log('\n=== 所有字段名 ===');
+    console.log(Object.keys(record || {}).join(', '));
+
+  } catch (error: any) {
+    console.error('REDCap 查询失败:', error.message);
+  }
+
+  // 3. 检查字段映射表
+  const fieldMappings = await prisma.iitFieldMapping.findMany({
+    where: { projectId: project.id },
+  });
+  console.log('\n=== 字段映射表 ===');
+  for (const m of fieldMappings) {
+    console.log(`  ${m.aliasName} -> ${m.actualName}`);
+  }
+
+  await prisma.$disconnect();
+}
+
+main().catch(console.error);
diff --git a/backend/debug-qc-field-mismatch.ts b/backend/debug-qc-field-mismatch.ts
new file mode 100644
index 00000000..4b7df316
--- /dev/null
+++ b/backend/debug-qc-field-mismatch.ts
@@ -0,0 +1,155 @@
+/**
+ * 调试脚本：诊断字段获取问题
+ * 
+ * 问题：
+ * 1. Record 1 有 age=21，但质控显示空
+ * 2. Record 3 应该有年龄但 API 返回无
+ */
+import { PrismaClient } from '@prisma/client';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+import jsonLogic from 'json-logic-js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('🔍 字段获取问题诊断');
+  console.log('='.repeat(60));
+
+  // 1. 获取项目配置
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+  });
+
+  if (!project) {
+    console.log('❌ 未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  // 2. 获取质控规则配置
+  const skill = await prisma.iitSkill.findFirst({
+    where: { projectId: project.id, isActive: true },
+  });
+
+  if (!skill) {
+    console.log('❌ 未找到激活的 Skill');
+    await prisma.$disconnect();
+    return;
+  }
+
+  const config = skill.config as any;
+  const rules = config?.rules || [];
+
+  console.log('\n📋 质控规则中的字段配置:');
+  for (const rule of rules) {
+    console.log(`  ${rule.name}:`);
+    console.log(`    field: "${rule.field}"`);
+    console.log(`    logic: ${JSON.stringify(rule.logic)}`);
+  }
+
+  // 3. 从 REDCap 获取原始数据（检查 Record 1 和 Record 3）
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 检查 Record 1 的原始 REDCap 数据');
+  console.log('='.repeat(60));
+
+  // 获取 Record 1 的原始记录（不合并）
+  const rawRecords1 = await adapter.exportRecords({ records: ['1'] });
+  console.log(`\nRecord 1 原始记录数: ${rawRecords1.length} (多事件)`);
+  for (const r of rawRecords1) {
+    console.log(`  事件: ${r.redcap_event_name || '(无)'}`);
+    console.log(`    age: ${r.age !== undefined ? r.age : '(字段不存在)'}`);
+    console.log(`    date_of_birth: ${r.date_of_birth || '(空)'}`);
+  }
+
+  // 获取 Record 1 合并后的数据
+  const merged1 = await adapter.getRecordById('1');
+  console.log(`\nRecord 1 合并后数据:`);
+  console.log(`  age: ${merged1?.age}`);
+  console.log(`  date_of_birth: ${merged1?.date_of_birth}`);
+
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 检查 Record 3 的原始 REDCap 数据');
+  console.log('='.repeat(60));
+
+  const rawRecords3 = await adapter.exportRecords({ records: ['3'] });
+  console.log(`\nRecord 3 原始记录数: ${rawRecords3.length} (多事件)`);
+  for (const r of rawRecords3) {
+    console.log(`  事件: ${r.redcap_event_name || '(无)'}`);
+    console.log(`    age: ${r.age !== undefined ? r.age : '(字段不存在)'}`);
+    console.log(`    date_of_birth: ${r.date_of_birth || '(空)'}`);
+  }
+
+  const merged3 = await adapter.getRecordById('3');
+  console.log(`\nRecord 3 合并后数据:`);
+  console.log(`  age: ${merged3?.age}`);
+  console.log(`  date_of_birth: ${merged3?.date_of_birth}`);
+
+  // 4. 模拟质控规则执行，看看哪里出问题
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 模拟质控规则执行 (Record 1)');
+  console.log('='.repeat(60));
+
+  // 找到年龄规则
+  const ageRule = rules.find((r: any) => r.name.includes('年龄'));
+  if (ageRule && merged1) {
+    console.log(`\n规则: ${ageRule.name}`);
+    console.log(`  field: "${ageRule.field}"`);
+    console.log(`  logic: ${JSON.stringify(ageRule.logic)}`);
+    
+    // 检查字段值
+    const fieldValue = merged1[ageRule.field];
+    console.log(`\n  从数据中获取 "${ageRule.field}" 的值: ${fieldValue} (类型: ${typeof fieldValue})`);
+    
+    // 尝试执行 JSON Logic
+    try {
+      const result = jsonLogic.apply(ageRule.logic, merged1);
+      console.log(`  JSON Logic 执行结果: ${result}`);
+    } catch (error: any) {
+      console.log(`  JSON Logic 执行失败: ${error.message}`);
+    }
+
+    // 列出数据中所有可能的年龄相关字段
+    console.log(`\n  数据中的年龄相关字段:`);
+    for (const [key, value] of Object.entries(merged1)) {
+      if (key.toLowerCase().includes('age') || key === ageRule.field) {
+        console.log(`    ${key}: ${value}`);
+      }
+    }
+  }
+
+  // 5. 检查 SkillRunner 如何获取记录
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 检查 SkillRunner 获取记录的方式');
+  console.log('='.repeat(60));
+
+  // 查看 getRecordsToProcess 的实现逻辑
+  // 它可能使用不同的方法获取数据
+  const allRecordsMerged = await adapter.getAllRecordsMerged();
+  console.log(`\ngetAllRecordsMerged 返回 ${allRecordsMerged.length} 条记录`);
+  
+  const r1FromAll = allRecordsMerged.find(r => r.record_id === '1');
+  const r3FromAll = allRecordsMerged.find(r => r.record_id === '3');
+  
+  console.log(`\nRecord 1 from getAllRecordsMerged:`);
+  console.log(`  age: ${r1FromAll?.age}`);
+  console.log(`  date_of_birth: ${r1FromAll?.date_of_birth}`);
+  
+  console.log(`\nRecord 3 from getAllRecordsMerged:`);
+  console.log(`  age: ${r3FromAll?.age}`);
+  console.log(`  date_of_birth: ${r3FromAll?.date_of_birth}`);
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ 诊断完成');
+  console.log('='.repeat(60));
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/backend/debug-qc.ts b/backend/debug-qc.ts
new file mode 100644
index 00000000..caaa51c8
--- /dev/null
+++ b/backend/debug-qc.ts
@@ -0,0 +1,73 @@
+/**
+ * 调试脚本：检查质控数据和规则
+ */
+import { PrismaClient } from '@prisma/client';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('=== 调试质控数据 ===\n');
+
+  // 1. 查找项目
+  const projects = await prisma.iitProject.findMany({
+    select: { id: true, name: true }
+  });
+  console.log('所有项目:', projects);
+
+  // 找 test0207 项目
+  const project = projects.find(p => p.name?.includes('test0207') || p.id?.includes('test0207'));
+  if (!project) {
+    console.log('未找到 test0207 项目');
+    await prisma.$disconnect();
+    return;
+  }
+  console.log('\n选中项目:', project);
+
+  // 2. 查看质控规则
+  const skills = await prisma.iitSkill.findMany({
+    where: { projectId: project.id },
+    select: { name: true, skillType: true, config: true }
+  });
+  console.log('\n质控技能:', skills.map(s => ({ name: s.name, type: s.skillType })));
+
+  // 找 qc_process 类型的规则
+  const qcSkill = skills.find(s => s.skillType === 'qc_process');
+  if (qcSkill) {
+    console.log('\n质控规则配置:');
+    const config = qcSkill.config as any;
+    if (config?.rules) {
+      for (const rule of config.rules) {
+        console.log(`  - ${rule.id}: ${rule.name}, field: ${rule.field}, message: ${rule.message}`);
+      }
+    }
+  }
+
+  // 3. 查看最近的质控日志
+  const logs = await prisma.iitQcLog.findMany({
+    where: { projectId: project.id },
+    take: 3,
+    orderBy: { createdAt: 'desc' },
+    select: { recordId: true, status: true, issues: true, createdAt: true }
+  });
+  console.log('\n最近质控日志:');
+  for (const log of logs) {
+    console.log(`  Record ${log.recordId}: ${log.status}`);
+    const issues = log.issues as any;
+    if (issues?.items) {
+      console.log(`    Issues (${issues.items.length}):`, issues.items.slice(0, 2).map((i: any) => i.ruleName));
+    } else if (Array.isArray(issues)) {
+      console.log(`    Issues (${issues.length}):`, issues.slice(0, 2).map((i: any) => i.ruleName || i.message));
+    }
+  }
+
+  // 4. 查看 REDCap 适配器配置
+  const projectFull = await prisma.iitProject.findUnique({
+    where: { id: project.id },
+    select: { redcapUrl: true, redcapProjectId: true }
+  });
+  console.log('\nREDCap 配置:', { url: projectFull?.redcapUrl, projectId: projectFull?.redcapProjectId });
+
+  await prisma.$disconnect();
+}
+
+main().catch(console.error);
diff --git a/backend/prisma/migrations/20260208134925_add_cra_qc_engine_support/migration.sql b/backend/prisma/migrations/20260208134925_add_cra_qc_engine_support/migration.sql
new file mode 100644
index 00000000..b821f4fa
--- /dev/null
+++ b/backend/prisma/migrations/20260208134925_add_cra_qc_engine_support/migration.sql
@@ -0,0 +1,30 @@
+-- CRA 智能质控引擎支持
+-- 扩展 IitSkill 表，新增 IitQcReport 表
+
+-- AlterTable: 扩展 skills 表支持 CRA 五大规则体系
+ALTER TABLE "iit_schema"."skills" ADD COLUMN     "level" TEXT NOT NULL DEFAULT 'normal',
+ADD COLUMN     "priority" INTEGER NOT NULL DEFAULT 100,
+ADD COLUMN     "required_tags" TEXT[] DEFAULT ARRAY[]::TEXT[],
+ADD COLUMN     "rule_type" TEXT NOT NULL DEFAULT 'HARD_RULE';
+
+-- CreateTable: 质控报告存储表
+CREATE TABLE "iit_schema"."qc_reports" (
+    "id" TEXT NOT NULL,
+    "project_id" TEXT NOT NULL,
+    "report_type" TEXT NOT NULL DEFAULT 'daily',
+    "summary" JSONB NOT NULL,
+    "issues" JSONB NOT NULL,
+    "llm_report" TEXT NOT NULL,
+    "generated_at" TIMESTAMP(3) NOT NULL DEFAULT CURRENT_TIMESTAMP,
+    "expires_at" TIMESTAMP(3),
+
+    CONSTRAINT "qc_reports_pkey" PRIMARY KEY ("id")
+);
+
+-- CreateIndex: 报告索引
+CREATE INDEX "idx_qc_report_project_type" ON "iit_schema"."qc_reports"("project_id", "report_type");
+
+CREATE INDEX "idx_qc_report_generated" ON "iit_schema"."qc_reports"("generated_at");
+
+-- CreateIndex: Skill 触发类型索引
+CREATE INDEX "idx_iit_skill_active_trigger" ON "iit_schema"."skills"("is_active", "trigger_type");
diff --git a/backend/prisma/schema.prisma b/backend/prisma/schema.prisma
index 18e5d9e7..11b45756 100644
--- a/backend/prisma/schema.prisma
+++ b/backend/prisma/schema.prisma
@@ -959,19 +959,26 @@ model IitAuditLog {
 
 /// Skill 配置存储表 - 存储质控规则、SOP流程图
 /// 支持 webhook/cron/event 三种触发方式
+/// V3.0 扩展：支持 CRA 五大规则体系
 model IitSkill {
   id           String   @id @default(uuid())
   projectId    String   @map("project_id")
-  skillType    String   @map("skill_type")        // qc_process | daily_briefing | general_chat | weekly_report | visit_reminder
+  skillType    String   @map("skill_type")        // qc_process | daily_briefing | general_chat | weekly_report | visit_reminder | variable_qc | inclusion_exclusion | protocol_deviation | ae_monitoring | ethics_compliance
   name         String                              // 技能名称
   description  String?                             // 技能描述
-  config       Json     @db.JsonB                  // 核心配置 JSON（SOP 流程图）
+  config       Json     @db.JsonB                  // 核心配置 JSON（SOP 流程图 / 规则定义）
   isActive     Boolean  @default(true) @map("is_active")
   version      Int      @default(1)
   
   // V2.9 新增：主动触发能力
-  triggerType  String   @default("webhook") @map("trigger_type")  // 'webhook' | 'cron' | 'event'
-  cronSchedule String?  @map("cron_schedule")      // Cron 表达式，如 "0 9 * * *"
+  triggerType  String   @default("webhook") @map("trigger_type")  // 'webhook' | 'cron' | 'manual'
+  cronSchedule String?  @map("cron_schedule")      // Cron 表达式，如 "0 2 * * *" (每日凌晨2点)
+  
+  // V3.0 新增：CRA 质控引擎支持
+  ruleType     String   @default("HARD_RULE") @map("rule_type")   // 'HARD_RULE' | 'LLM_CHECK' | 'HYBRID'
+  level        String   @default("normal") @map("level")          // 'blocking' | 'normal' - 阻断性检查优先
+  priority     Int      @default(100) @map("priority")            // 执行优先级，数字越小越优先
+  requiredTags String[] @default([]) @map("required_tags")        // 数据依赖标签，如 ['#lab', '#demographics']
   
   createdAt    DateTime @default(now()) @map("created_at")
   updatedAt    DateTime @updatedAt @map("updated_at")
@@ -979,10 +986,41 @@ model IitSkill {
   @@unique([projectId, skillType], map: "unique_iit_skill_project_type")
   @@index([projectId], map: "idx_iit_skill_project")
   @@index([isActive], map: "idx_iit_skill_active")
+  @@index([isActive, triggerType], map: "idx_iit_skill_active_trigger")
   @@map("skills")
   @@schema("iit_schema")
 }
 
+/// 质控报告存储表 - 存储预生成的 LLM 友好报告
+/// 报告驱动模式：后台预计算 → LLM 阅读报告 → 回答用户
+model IitQcReport {
+  id           String   @id @default(uuid())
+  projectId    String   @map("project_id")
+  
+  // 报告类型
+  reportType   String   @default("daily") @map("report_type")  // 'daily' | 'weekly' | 'on_demand'
+  
+  // 统计摘要
+  summary      Json     @db.JsonB  // { totalRecords, criticalIssues, pendingQueries, passRate }
+  
+  // 详细问题列表
+  issues       Json     @db.JsonB  // [{ record, rule, severity, description, evidence }]
+  
+  // LLM 友好的 XML 报告
+  llmReport    String   @map("llm_report") @db.Text
+  
+  // 报告生成时间
+  generatedAt  DateTime @default(now()) @map("generated_at")
+  
+  // 报告有效期（过期后需重新生成）
+  expiresAt    DateTime? @map("expires_at")
+  
+  @@index([projectId, reportType], map: "idx_qc_report_project_type")
+  @@index([generatedAt], map: "idx_qc_report_generated")
+  @@map("qc_reports")
+  @@schema("iit_schema")
+}
+
 /// 字段名映射字典表 - 解决 LLM 生成的字段名与 REDCap 实际字段名不一致的问题
 model IitFieldMapping {
   id          String   @id @default(uuid())
diff --git a/backend/prisma/seeds/cra-qc-skills.seed.ts b/backend/prisma/seeds/cra-qc-skills.seed.ts
new file mode 100644
index 00000000..2a67c291
--- /dev/null
+++ b/backend/prisma/seeds/cra-qc-skills.seed.ts
@@ -0,0 +1,384 @@
+/**
+ * CRA 智能质控引擎 - 默认规则配置 Seed
+ * 
+ * 五大规则体系：
+ * 1. 变量质控 (VARIABLE_QC) - 硬规则
+ * 2. 入排标准 (INCLUSION_EXCLUSION) - LLM 检查
+ * 3. 方案偏离 (PROTOCOL_DEVIATION) - 混合规则
+ * 4. AE 监测 (AE_MONITORING) - LLM 检查
+ * 5. 伦理合规 (ETHICS_COMPLIANCE) - 硬规则
+ */
+
+import { PrismaClient } from '@prisma/client';
+
+const prisma = new PrismaClient();
+
+/**
+ * 默认 Skills 配置
+ */
+const DEFAULT_SKILLS = [
+  // ============================================================
+  // 1. 变量质控 - 硬规则 (Level: normal, 实时触发)
+  // ============================================================
+  {
+    skillType: 'variable_qc',
+    name: '变量质控',
+    description: '针对每个变量的数据校验，包括空值检查、数值范围、格式验证',
+    ruleType: 'HARD_RULE',
+    level: 'normal',
+    priority: 100,
+    triggerType: 'webhook',
+    requiredTags: ['#demographics', '#lab'],
+    config: {
+      engine: 'HardRuleEngine',
+      rules: [
+        {
+          id: 'VQ-001',
+          name: '年龄范围检查',
+          field: 'age',
+          formName: 'demographics',
+          logic: {
+            and: [
+              { '>=': [{ var: 'age' }, 18] },
+              { '<=': [{ var: 'age' }, 100] },
+            ],
+          },
+          message: '年龄超出合理范围 (18-100岁)',
+          severity: 'error',
+          category: 'lab_values',
+        },
+        {
+          id: 'VQ-002',
+          name: 'BMI 范围检查',
+          field: 'bmi',
+          formName: 'demographics',
+          logic: {
+            and: [
+              { '>': [{ var: 'bmi' }, 10] },
+              { '<': [{ var: 'bmi' }, 60] },
+            ],
+          },
+          message: 'BMI 值异常 (正常范围 10-60)',
+          severity: 'warning',
+          category: 'lab_values',
+        },
+        {
+          id: 'VQ-003',
+          name: '体重范围检查',
+          field: 'weight',
+          formName: 'demographics',
+          logic: {
+            and: [
+              { '>': [{ var: 'weight' }, 20] },
+              { '<': [{ var: 'weight' }, 300] },
+            ],
+          },
+          message: '体重值异常 (正常范围 20-300kg)',
+          severity: 'warning',
+          category: 'lab_values',
+        },
+        {
+          id: 'VQ-004',
+          name: '身高范围检查',
+          field: 'height',
+          formName: 'demographics',
+          logic: {
+            and: [
+              { '>': [{ var: 'height' }, 50] },
+              { '<': [{ var: 'height' }, 250] },
+            ],
+          },
+          message: '身高值异常 (正常范围 50-250cm)',
+          severity: 'warning',
+          category: 'lab_values',
+        },
+      ],
+    },
+  },
+
+  // ============================================================
+  // 2. 入排标准 - LLM 检查 (Level: normal, 定时触发)
+  // ============================================================
+  {
+    skillType: 'inclusion_exclusion',
+    name: '入排标准核查',
+    description: '判断受试者是否符合研究方案的入组标准和排除标准',
+    ruleType: 'LLM_CHECK',
+    level: 'normal',
+    priority: 200,
+    triggerType: 'cron',
+    cronSchedule: '0 2 * * *', // 每日凌晨 2 点
+    requiredTags: ['#demographics', '#medical_history', '#lab'],
+    config: {
+      engine: 'SoftRuleEngine',
+      model: 'deepseek-v3',
+      systemPrompt: '你是一个专业的临床研究监查员，负责核查受试者是否符合入组标准。',
+      checks: [
+        {
+          id: 'IE-001',
+          name: '年龄入组标准',
+          desc: '检查受试者年龄是否符合研究方案规定的入组年龄范围',
+          promptTemplate: `请根据以下受试者数据，判断其年龄是否符合入组标准。
+
+受试者年龄: {{age}}
+
+研究方案通常要求受试者年龄在 18-75 岁之间。请判断此受试者是否符合年龄入组标准。`,
+          requiredTags: ['#demographics'],
+          category: 'inclusion',
+          severity: 'critical',
+        },
+        {
+          id: 'IE-002',
+          name: '确诊时间入组标准',
+          desc: '检查受试者确诊时间是否在研究方案规定的时间窗口内',
+          promptTemplate: `请根据以下受试者数据，判断其确诊时间是否符合入组标准。
+
+确诊日期: {{diagnosis_date}}
+入组日期: {{enrollment_date}}
+
+研究方案通常要求确诊时间在入组前一定时间内（如 3 个月、6 个月等）。请判断此受试者是否符合确诊时间入组标准。`,
+          requiredTags: ['#demographics', '#medical_history'],
+          category: 'inclusion',
+          severity: 'critical',
+        },
+      ],
+    },
+  },
+
+  // ============================================================
+  // 3. 方案偏离 - 混合规则 (Level: normal, 定时触发)
+  // ============================================================
+  {
+    skillType: 'protocol_deviation',
+    name: '方案偏离检测',
+    description: '检测访视超窗、漏做检查、违反用药规定等方案偏离情况',
+    ruleType: 'HYBRID',
+    level: 'normal',
+    priority: 300,
+    triggerType: 'cron',
+    cronSchedule: '0 3 * * *', // 每日凌晨 3 点
+    requiredTags: ['#visits', '#medications'],
+    config: {
+      engine: 'HybridEngine',
+      hardRules: [
+        {
+          id: 'PD-001',
+          name: '访视间隔检查',
+          field: ['visit_1_date', 'visit_2_date'],
+          logic: {
+            '<=': [
+              { '-': [{ var: 'visit_2_date' }, { var: 'visit_1_date' }] },
+              31, // 最大间隔 28+3 天
+            ],
+          },
+          message: '访视超窗：访视 2 与访视 1 间隔超过 31 天',
+          severity: 'warning',
+          category: 'logic_check',
+        },
+      ],
+      softChecks: [
+        {
+          id: 'PD-002',
+          name: '禁用药物检查',
+          desc: '检查受试者是否使用了研究方案禁止的药物',
+          promptTemplate: '请检查受试者的用药记录，判断是否存在使用研究方案禁止药物的情况。',
+          requiredTags: ['#medications'],
+          category: 'protocol_deviation',
+          severity: 'warning',
+        },
+      ],
+    },
+  },
+
+  // ============================================================
+  // 4. AE 监测 - LLM 检查 (Level: normal, 定时触发)
+  // ============================================================
+  {
+    skillType: 'ae_monitoring',
+    name: 'AE 事件监测',
+    description: '检测未报告的不良事件，包括实验室异常与 AE 记录的一致性检查',
+    ruleType: 'LLM_CHECK',
+    level: 'normal',
+    priority: 250,
+    triggerType: 'cron',
+    cronSchedule: '0 4 * * *', // 每日凌晨 4 点
+    requiredTags: ['#lab', '#ae'],
+    config: {
+      engine: 'SoftRuleEngine',
+      model: 'deepseek-v3',
+      systemPrompt: '你是一个专业的药物安全监查员，负责核查不良事件报告的完整性和准确性。',
+      checks: [
+        {
+          id: 'AE-001',
+          name: 'Lab 异常与 AE 一致性',
+          desc: '检查实验室检查异常值是否已在 AE 表中报告',
+          promptTemplate: `请对比以下实验室检查数据和不良事件记录，判断是否存在未报告的实验室异常。
+
+重点关注：
+1. Grade 3 及以上的实验室异常是否已记录为 AE
+2. 持续异常是否已报告
+3. 与基线相比显著变化的指标
+
+请给出判断结果，并列出可能遗漏报告的异常。`,
+          requiredTags: ['#lab', '#ae'],
+          category: 'ae_detection',
+          severity: 'critical',
+        },
+        {
+          id: 'AE-002',
+          name: 'SAE 报告时效性',
+          desc: '检查严重不良事件是否在规定时间内报告',
+          promptTemplate: `请检查以下 SAE 记录，判断报告时效是否符合法规要求。
+
+通常要求：
+- 致死/危及生命的 SAE: 24 小时内报告
+- 其他 SAE: 15 天内报告
+
+请判断各 SAE 的报告时效是否合规。`,
+          requiredTags: ['#ae'],
+          category: 'ae_detection',
+          severity: 'critical',
+        },
+      ],
+    },
+  },
+
+  // ============================================================
+  // 5. 伦理合规 - 硬规则 (Level: blocking, 实时触发)
+  // ============================================================
+  {
+    skillType: 'ethics_compliance',
+    name: '伦理合规检查',
+    description: '检查知情同意书签署时间、隐私保护等伦理合规问题',
+    ruleType: 'HARD_RULE',
+    level: 'blocking', // 阻断性检查，失败则跳过后续 AI 检查
+    priority: 10, // 最高优先级
+    triggerType: 'webhook',
+    requiredTags: ['#consent', '#demographics'],
+    config: {
+      engine: 'HardRuleEngine',
+      rules: [
+        {
+          id: 'EC-001',
+          name: '知情同意书签署时间',
+          field: ['icf_date', 'first_visit_date'],
+          logic: {
+            '<=': [{ var: 'icf_date' }, { var: 'first_visit_date' }],
+          },
+          message: '伦理违规：知情同意书签署日期晚于首次访视日期',
+          severity: 'error',
+          category: 'ethics',
+        },
+        {
+          id: 'EC-002',
+          name: '知情同意书必填检查',
+          field: 'icf_date',
+          logic: {
+            '!!': [{ var: 'icf_date' }],
+          },
+          message: '伦理违规：缺少知情同意书签署日期',
+          severity: 'error',
+          category: 'ethics',
+        },
+        {
+          id: 'EC-003',
+          name: '受试者 ID 必填检查',
+          field: 'record_id',
+          logic: {
+            '!!': [{ var: 'record_id' }],
+          },
+          message: '数据完整性：缺少受试者 ID',
+          severity: 'error',
+          category: 'ethics',
+        },
+      ],
+    },
+  },
+];
+
+/**
+ * 为项目创建默认 Skills
+ * 
+ * @param projectId 项目 ID
+ */
+export async function seedDefaultSkills(projectId: string): Promise<void> {
+  console.log(`[Seed] Creating default skills for project: ${projectId}`);
+
+  for (const skillData of DEFAULT_SKILLS) {
+    try {
+      // 使用 upsert 避免重复创建
+      await prisma.iitSkill.upsert({
+        where: {
+          projectId_skillType: {
+            projectId,
+            skillType: skillData.skillType,
+          },
+        },
+        update: {
+          name: skillData.name,
+          description: skillData.description,
+          ruleType: skillData.ruleType,
+          level: skillData.level,
+          priority: skillData.priority,
+          triggerType: skillData.triggerType,
+          cronSchedule: skillData.cronSchedule,
+          requiredTags: skillData.requiredTags,
+          config: skillData.config,
+          isActive: true,
+          updatedAt: new Date(),
+        },
+        create: {
+          projectId,
+          skillType: skillData.skillType,
+          name: skillData.name,
+          description: skillData.description,
+          ruleType: skillData.ruleType,
+          level: skillData.level,
+          priority: skillData.priority,
+          triggerType: skillData.triggerType,
+          cronSchedule: skillData.cronSchedule,
+          requiredTags: skillData.requiredTags,
+          config: skillData.config,
+          isActive: true,
+        },
+      });
+
+      console.log(`[Seed] Created/Updated skill: ${skillData.name}`);
+    } catch (error: any) {
+      console.error(`[Seed] Failed to create skill: ${skillData.name}`, error.message);
+    }
+  }
+
+  console.log(`[Seed] Completed creating default skills for project: ${projectId}`);
+}
+
+/**
+ * 主函数 - 可以直接运行
+ */
+async function main() {
+  // 获取命令行参数
+  const projectId = process.argv[2];
+
+  if (!projectId) {
+    console.error('Usage: npx ts-node prisma/seeds/cra-qc-skills.seed.ts <projectId>');
+    console.error('Example: npx ts-node prisma/seeds/cra-qc-skills.seed.ts test0102-pd-study');
+    process.exit(1);
+  }
+
+  // 检查项目是否存在
+  const project = await prisma.iitProject.findUnique({
+    where: { id: projectId },
+  });
+
+  if (!project) {
+    console.error(`Project not found: ${projectId}`);
+    process.exit(1);
+  }
+
+  await seedDefaultSkills(projectId);
+}
+
+// 如果直接运行此文件
+main()
+  .catch(console.error)
+  .finally(() => prisma.$disconnect());
diff --git a/backend/src/index.ts b/backend/src/index.ts
index 9fb772b7..34e39ad0 100644
--- a/backend/src/index.ts
+++ b/backend/src/index.ts
@@ -109,7 +109,7 @@ import { tenantRoutes, moduleRoutes } from './modules/admin/routes/tenantRoutes.
 import { userRoutes } from './modules/admin/routes/userRoutes.js';
 import { statsRoutes, userOverviewRoute } from './modules/admin/routes/statsRoutes.js';
 import { systemKbRoutes } from './modules/admin/system-kb/index.js';
-import { iitProjectRoutes, iitQcRuleRoutes, iitUserMappingRoutes, iitBatchRoutes } from './modules/admin/iit-projects/index.js';
+import { iitProjectRoutes, iitQcRuleRoutes, iitUserMappingRoutes, iitBatchRoutes, iitQcCockpitRoutes } from './modules/admin/iit-projects/index.js';
 await fastify.register(tenantRoutes, { prefix: '/api/admin/tenants' });
 await fastify.register(moduleRoutes, { prefix: '/api/admin/modules' });
 await fastify.register(userRoutes, { prefix: '/api/admin/users' });
@@ -120,6 +120,7 @@ await fastify.register(iitProjectRoutes, { prefix: '/api/v1/admin/iit-projects'
 await fastify.register(iitQcRuleRoutes, { prefix: '/api/v1/admin/iit-projects' });
 await fastify.register(iitUserMappingRoutes, { prefix: '/api/v1/admin/iit-projects' });
 await fastify.register(iitBatchRoutes, { prefix: '/api/v1/admin/iit-projects' });  // 一键全量质控/汇总
+await fastify.register(iitQcCockpitRoutes, { prefix: '/api/v1/admin/iit-projects' });  // 质控驾驶舱
 logger.info('✅ 运营管理路由已注册: /api/admin/tenants, /api/admin/modules, /api/admin/users, /api/admin/stats, /api/v1/admin/system-kb, /api/v1/admin/iit-projects');
 
 // ============================================
diff --git a/backend/src/modules/admin/iit-projects/iitBatchController.ts b/backend/src/modules/admin/iit-projects/iitBatchController.ts
index 0a221e21..f6759555 100644
--- a/backend/src/modules/admin/iit-projects/iitBatchController.ts
+++ b/backend/src/modules/admin/iit-projects/iitBatchController.ts
@@ -2,19 +2,21 @@
  * IIT 批量操作 Controller
  * 
  * 功能：
- * - 一键全量质控
+ * - 一键全量质控（事件级）
  * - 一键全量数据汇总
  * 
  * 用途：
  * - 运营管理端手动触发
  * - 未来可作为 AI 工具暴露
+ * 
+ * 版本：v3.1 - 事件级质控
  */
 
 import { FastifyRequest, FastifyReply } from 'fastify';
 import { PrismaClient } from '@prisma/client';
 import { logger } from '../../../common/logging/index.js';
 import { RedcapAdapter } from '../../iit-manager/adapters/RedcapAdapter.js';
-import { createHardRuleEngine } from '../../iit-manager/engines/HardRuleEngine.js';
+import { createSkillRunner } from '../../iit-manager/engines/SkillRunner.js';
 
 const prisma = new PrismaClient();
 
@@ -24,15 +26,15 @@ interface BatchRequest {
 
 export class IitBatchController {
   /**
-   * 一键全量质控
+   * 一键全量质控（事件级）
    * 
    * POST /api/v1/admin/iit-projects/:projectId/batch-qc
    * 
    * 功能：
-   * 1. 获取 REDCap 中所有记录
-   * 2. 对每条记录执行质控
-   * 3. 存储质控日志到 iit_qc_logs
-   * 4. 更新项目统计到 iit_qc_project_stats
+   * 1. 使用 SkillRunner 进行事件级质控
+   * 2. 每个 record+event 组合独立质控
+   * 3. 规则根据 applicableEvents/applicableForms 动态过滤
+   * 4. 质控日志自动保存到 iit_qc_logs（含 eventId）
    */
   async batchQualityCheck(
     request: FastifyRequest<BatchRequest>,
@@ -42,7 +44,7 @@ export class IitBatchController {
     const startTime = Date.now();
 
     try {
-      logger.info('🔄 开始全量质控', { projectId });
+      logger.info('🔄 开始事件级全量质控', { projectId });
 
       // 1. 获取项目配置
       const project = await prisma.iitProject.findUnique({
@@ -53,141 +55,111 @@ export class IitBatchController {
         return reply.status(404).send({ error: '项目不存在' });
       }
 
-      // 2. 从 REDCap 获取所有记录
-      const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
-      const allRecords = await adapter.exportRecords({});
+      // 2. 使用 SkillRunner 执行事件级质控
+      const runner = await createSkillRunner(projectId);
+      const results = await runner.runByTrigger('manual');
 
-      if (!allRecords || allRecords.length === 0) {
+      if (results.length === 0) {
         return reply.send({
           success: true,
-          message: '项目暂无记录',
-          stats: { totalRecords: 0 }
+          message: '项目暂无记录或未配置质控规则',
+          stats: { totalRecords: 0, totalEvents: 0 }
         });
       }
 
-      // 3. 按 record_id 分组
-      const recordMap = new Map<string, any>();
-      for (const record of allRecords) {
-        const recordId = record.record_id || record.id;
-        if (recordId) {
-          // 合并同一记录的多个事件数据
-          const existing = recordMap.get(recordId) || {};
-          recordMap.set(recordId, { ...existing, ...record });
-        }
-      }
-
-      // 4. 执行质控
-      const engine = await createHardRuleEngine(projectId);
-      const ruleVersion = new Date().toISOString().split('T')[0];
-
+      // 3. 统计（按 record+event 组合）
       let passCount = 0;
       let failCount = 0;
       let warningCount = 0;
+      let uncertainCount = 0;
 
-      for (const [recordId, recordData] of recordMap.entries()) {
-        const qcResult = engine.execute(recordId, recordData);
+      const uniqueRecords = new Set<string>();
 
-        // 存储质控日志
-        const issues = [
-          ...qcResult.errors.map((e: any) => ({
-            field: e.field,
-            rule: e.ruleName,
-            level: 'RED',
-            message: e.message
-          })),
-          ...qcResult.warnings.map((w: any) => ({
-            field: w.field,
-            rule: w.ruleName,
-            level: 'YELLOW',
-            message: w.message
-          }))
-        ];
+      for (const result of results) {
+        uniqueRecords.add(result.recordId);
+        
+        if (result.overallStatus === 'PASS') passCount++;
+        else if (result.overallStatus === 'FAIL') failCount++;
+        else if (result.overallStatus === 'WARNING') warningCount++;
+        else uncertainCount++;
 
-        await prisma.iitQcLog.create({
-          data: {
-            projectId,
-            recordId,
-            qcType: 'holistic',  // 全案质控
-            status: qcResult.overallStatus,
-            issues,
-            rulesEvaluated: qcResult.summary.totalRules,
-            rulesSkipped: 0,
-            rulesPassed: qcResult.summary.passed,
-            rulesFailed: qcResult.summary.failed,
-            ruleVersion,
-            triggeredBy: 'manual'
-          }
+        // 更新录入汇总表（取最差状态）
+        const existingSummary = await prisma.iitRecordSummary.findUnique({
+          where: { projectId_recordId: { projectId, recordId: result.recordId } }
         });
 
-        // 更新录入汇总表的质控状态
-        await prisma.iitRecordSummary.upsert({
-          where: {
-            projectId_recordId: { projectId, recordId }
-          },
-          create: {
-            projectId,
-            recordId,
-            lastUpdatedAt: new Date(),
-            latestQcStatus: qcResult.overallStatus,
-            latestQcAt: new Date(),
-            formStatus: {},
-            updateCount: 1
-          },
-          update: {
-            latestQcStatus: qcResult.overallStatus,
-            latestQcAt: new Date()
-          }
-        });
+        const statusPriority: Record<string, number> = { 'FAIL': 3, 'WARNING': 2, 'UNCERTAIN': 1, 'PASS': 0 };
+        const currentPriority = statusPriority[result.overallStatus] || 0;
+        const existingPriority = statusPriority[existingSummary?.latestQcStatus || 'PASS'] || 0;
 
-        // 统计
-        if (qcResult.overallStatus === 'PASS') passCount++;
-        else if (qcResult.overallStatus === 'FAIL') failCount++;
-        else warningCount++;
+        // 只更新为更严重的状态
+        if (!existingSummary || currentPriority > existingPriority) {
+          await prisma.iitRecordSummary.upsert({
+            where: { projectId_recordId: { projectId, recordId: result.recordId } },
+            create: {
+              projectId,
+              recordId: result.recordId,
+              lastUpdatedAt: new Date(),
+              latestQcStatus: result.overallStatus,
+              latestQcAt: new Date(),
+              formStatus: {},
+              updateCount: 1
+            },
+            update: {
+              latestQcStatus: result.overallStatus,
+              latestQcAt: new Date()
+            }
+          });
+        }
       }
 
-      // 5. 更新项目统计表
+      // 4. 更新项目统计表
       await prisma.iitQcProjectStats.upsert({
         where: { projectId },
         create: {
           projectId,
-          totalRecords: recordMap.size,
+          totalRecords: uniqueRecords.size,
           passedRecords: passCount,
           failedRecords: failCount,
-          warningRecords: warningCount
+          warningRecords: warningCount + uncertainCount
         },
         update: {
-          totalRecords: recordMap.size,
+          totalRecords: uniqueRecords.size,
           passedRecords: passCount,
           failedRecords: failCount,
-          warningRecords: warningCount
+          warningRecords: warningCount + uncertainCount
         }
       });
 
       const durationMs = Date.now() - startTime;
-      logger.info('✅ 全量质控完成', {
+      logger.info('✅ 事件级全量质控完成', {
         projectId,
-        totalRecords: recordMap.size,
+        uniqueRecords: uniqueRecords.size,
+        totalEventCombinations: results.length,
         passCount,
         failCount,
         warningCount,
+        uncertainCount,
         durationMs
       });
 
       return reply.send({
         success: true,
-        message: '全量质控完成',
+        message: '事件级全量质控完成',
         stats: {
-          totalRecords: recordMap.size,
+          totalRecords: uniqueRecords.size,
+          totalEventCombinations: results.length,
           passed: passCount,
           failed: failCount,
           warnings: warningCount,
-          passRate: `${((passCount / recordMap.size) * 100).toFixed(1)}%`
+          uncertain: uncertainCount,
+          passRate: `${((passCount / results.length) * 100).toFixed(1)}%`
         },
         durationMs
       });
 
     } catch (error: any) {
-      logger.error('❌ 全量质控失败', { projectId, error: error.message });
+      logger.error('❌ 事件级全量质控失败', { projectId, error: error.message });
       return reply.status(500).send({ error: `质控失败: ${error.message}` });
     }
   }
diff --git a/backend/src/modules/admin/iit-projects/iitProjectService.ts b/backend/src/modules/admin/iit-projects/iitProjectService.ts
index b05f9ac1..9f537483 100644
--- a/backend/src/modules/admin/iit-projects/iitProjectService.ts
+++ b/backend/src/modules/admin/iit-projects/iitProjectService.ts
@@ -290,6 +290,11 @@ export class IitProjectService {
 
   /**
    * 同步 REDCap 元数据
+   * 
+   * 功能：
+   * 1. 从 REDCap 获取字段元数据
+   * 2. 将元数据保存到 iitFieldMetadata 表（用于热力图表单列、字段验证等）
+   * 3. 更新项目的 lastSyncAt 时间戳
    */
   async syncMetadata(projectId: string) {
     const project = await this.prisma.iitProject.findFirst({
@@ -302,23 +307,83 @@ export class IitProjectService {
 
     try {
       const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
-      const metadata = await adapter.exportMetadata();
+      
+      // ✅ 并行获取字段元数据和表单信息
+      const [metadata, instruments] = await Promise.all([
+        adapter.exportMetadata(),
+        adapter.exportInstruments(),
+      ]);
 
-      // 更新最后同步时间
-      await this.prisma.iitProject.update({
-        where: { id: projectId },
-        data: { lastSyncAt: new Date() },
+      // ✅ 构建表单名 -> 表单标签的映射
+      const formLabels: Record<string, string> = {};
+      for (const inst of instruments) {
+        formLabels[inst.instrument_name] = inst.instrument_label;
+      }
+
+      const now = new Date();
+      
+      // 构建待插入的数据
+      const fieldDataList = metadata.map((field: any) => ({
+        projectId,
+        fieldName: field.field_name || '',
+        fieldLabel: field.field_label || field.field_name || '',
+        fieldType: field.field_type || 'text',
+        formName: field.form_name || 'default',
+        sectionHeader: field.section_header || null,
+        validation: field.text_validation_type_or_show_slider_number || null,
+        validationMin: field.text_validation_min || null,
+        validationMax: field.text_validation_max || null,
+        choices: field.select_choices_or_calculations || null,
+        required: field.required_field === 'y',
+        branching: field.branching_logic || null,
+        ruleSource: 'auto',
+        syncedAt: now,
+      }));
+
+      // 使用事务确保数据一致性
+      await this.prisma.$transaction(async (tx) => {
+        // 删除该项目的旧元数据
+        await tx.iitFieldMetadata.deleteMany({
+          where: { projectId },
+        });
+
+        // 批量插入新元数据
+        if (fieldDataList.length > 0) {
+          await tx.iitFieldMetadata.createMany({
+            data: fieldDataList,
+          });
+        }
+
+        // ✅ 更新项目的最后同步时间和表单标签映射
+        await tx.iitProject.update({
+          where: { id: projectId },
+          data: { 
+            lastSyncAt: now,
+            fieldMappings: {
+              ...(project.fieldMappings as object || {}),
+              formLabels,  // 保存表单名 -> 表单标签的映射
+            },
+          },
+        });
       });
 
+      // 统计表单数量
+      const uniqueForms = [...new Set(metadata.map((f: any) => f.form_name))];
+
       logger.info('同步 REDCap 元数据成功', {
         projectId,
         fieldCount: metadata.length,
+        formCount: uniqueForms.length,
+        forms: uniqueForms,
+        formLabels,
       });
 
       return {
         success: true,
         fieldCount: metadata.length,
-        metadata,
+        formCount: uniqueForms.length,
+        forms: uniqueForms,
+        formLabels,
       };
     } catch (error) {
       const message = error instanceof Error ? error.message : String(error);
diff --git a/backend/src/modules/admin/iit-projects/iitQcCockpitController.ts b/backend/src/modules/admin/iit-projects/iitQcCockpitController.ts
new file mode 100644
index 00000000..2661f843
--- /dev/null
+++ b/backend/src/modules/admin/iit-projects/iitQcCockpitController.ts
@@ -0,0 +1,191 @@
+/**
+ * IIT 质控驾驶舱控制器
+ * 
+ * API:
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit/records/:recordId
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit/report
+ * - POST /api/v1/admin/iit-projects/:projectId/qc-cockpit/report/refresh
+ */
+
+import { FastifyRequest, FastifyReply } from 'fastify';
+import { iitQcCockpitService } from './iitQcCockpitService.js';
+import { QcReportService } from '../../iit-manager/services/QcReportService.js';
+import { logger } from '../../../common/logging/index.js';
+
+class IitQcCockpitController {
+  /**
+   * 获取质控驾驶舱数据
+   */
+  async getCockpitData(
+    request: FastifyRequest<{
+      Params: { projectId: string };
+    }>,
+    reply: FastifyReply
+  ) {
+    const { projectId } = request.params;
+    const startTime = Date.now();
+
+    try {
+      const data = await iitQcCockpitService.getCockpitData(projectId);
+
+      logger.info('[QcCockpitController] 获取驾驶舱数据成功', {
+        projectId,
+        totalRecords: data.stats.totalRecords,
+        durationMs: Date.now() - startTime,
+      });
+
+      return reply.code(200).send({
+        success: true,
+        data,
+      });
+    } catch (error: any) {
+      logger.error('[QcCockpitController] 获取驾驶舱数据失败', {
+        projectId,
+        error: error.message,
+      });
+
+      return reply.code(500).send({
+        success: false,
+        error: error.message,
+      });
+    }
+  }
+
+  /**
+   * 获取记录质控详情
+   */
+  async getRecordDetail(
+    request: FastifyRequest<{
+      Params: { projectId: string; recordId: string };
+      Querystring: { formName?: string };
+    }>,
+    reply: FastifyReply
+  ) {
+    const { projectId, recordId } = request.params;
+    const { formName = 'default' } = request.query;
+    const startTime = Date.now();
+
+    try {
+      const data = await iitQcCockpitService.getRecordDetail(
+        projectId,
+        recordId,
+        formName
+      );
+
+      logger.info('[QcCockpitController] 获取记录详情成功', {
+        projectId,
+        recordId,
+        formName,
+        issueCount: data.issues.length,
+        durationMs: Date.now() - startTime,
+      });
+
+      return reply.code(200).send({
+        success: true,
+        data,
+      });
+    } catch (error: any) {
+      logger.error('[QcCockpitController] 获取记录详情失败', {
+        projectId,
+        recordId,
+        formName,
+        error: error.message,
+      });
+
+      return reply.code(500).send({
+        success: false,
+        error: error.message,
+      });
+    }
+  }
+
+  /**
+   * 获取质控报告
+   */
+  async getReport(
+    request: FastifyRequest<{
+      Params: { projectId: string };
+      Querystring: { format?: 'json' | 'xml' };
+    }>,
+    reply: FastifyReply
+  ) {
+    const { projectId } = request.params;
+    const { format = 'json' } = request.query;
+    const startTime = Date.now();
+
+    try {
+      const report = await QcReportService.getReport(projectId);
+
+      logger.info('[QcCockpitController] 获取质控报告成功', {
+        projectId,
+        format,
+        criticalIssues: report.criticalIssues.length,
+        warningIssues: report.warningIssues.length,
+        durationMs: Date.now() - startTime,
+      });
+
+      if (format === 'xml') {
+        return reply
+          .code(200)
+          .header('Content-Type', 'application/xml; charset=utf-8')
+          .send(report.llmFriendlyXml);
+      }
+
+      return reply.code(200).send({
+        success: true,
+        data: report,
+      });
+    } catch (error: any) {
+      logger.error('[QcCockpitController] 获取质控报告失败', {
+        projectId,
+        error: error.message,
+      });
+
+      return reply.code(500).send({
+        success: false,
+        error: error.message,
+      });
+    }
+  }
+
+  /**
+   * 刷新质控报告
+   */
+  async refreshReport(
+    request: FastifyRequest<{
+      Params: { projectId: string };
+    }>,
+    reply: FastifyReply
+  ) {
+    const { projectId } = request.params;
+    const startTime = Date.now();
+
+    try {
+      const report = await QcReportService.refreshReport(projectId);
+
+      logger.info('[QcCockpitController] 刷新质控报告成功', {
+        projectId,
+        durationMs: Date.now() - startTime,
+      });
+
+      return reply.code(200).send({
+        success: true,
+        data: report,
+      });
+    } catch (error: any) {
+      logger.error('[QcCockpitController] 刷新质控报告失败', {
+        projectId,
+        error: error.message,
+      });
+
+      return reply.code(500).send({
+        success: false,
+        error: error.message,
+      });
+    }
+  }
+}
+
+export const iitQcCockpitController = new IitQcCockpitController();
+export { IitQcCockpitController };
diff --git a/backend/src/modules/admin/iit-projects/iitQcCockpitRoutes.ts b/backend/src/modules/admin/iit-projects/iitQcCockpitRoutes.ts
new file mode 100644
index 00000000..99b1df74
--- /dev/null
+++ b/backend/src/modules/admin/iit-projects/iitQcCockpitRoutes.ts
@@ -0,0 +1,245 @@
+/**
+ * IIT 质控驾驶舱路由
+ * 
+ * API:
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit                    获取驾驶舱数据
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit/records/:recordId  获取记录详情
+ * - GET /api/v1/admin/iit-projects/:projectId/qc-cockpit/report             获取质控报告
+ * - POST /api/v1/admin/iit-projects/:projectId/qc-cockpit/report/refresh    刷新质控报告
+ */
+
+import { FastifyInstance } from 'fastify';
+import { iitQcCockpitController } from './iitQcCockpitController.js';
+
+export async function iitQcCockpitRoutes(fastify: FastifyInstance) {
+  // 获取质控驾驶舱数据
+  fastify.get('/:projectId/qc-cockpit', {
+    schema: {
+      description: '获取质控驾驶舱数据（统计 + 热力图）',
+      tags: ['IIT Admin - 质控驾驶舱'],
+      params: {
+        type: 'object',
+        properties: {
+          projectId: { type: 'string', description: 'IIT 项目 ID' },
+        },
+        required: ['projectId'],
+      },
+      response: {
+        200: {
+          type: 'object',
+          properties: {
+            success: { type: 'boolean' },
+            data: {
+              type: 'object',
+              properties: {
+                stats: {
+                  type: 'object',
+                  properties: {
+                    qualityScore: { type: 'number' },
+                    totalRecords: { type: 'number' },
+                    passedRecords: { type: 'number' },
+                    failedRecords: { type: 'number' },
+                    warningRecords: { type: 'number' },
+                    pendingRecords: { type: 'number' },
+                    criticalCount: { type: 'number' },
+                    queryCount: { type: 'number' },
+                    deviationCount: { type: 'number' },
+                    passRate: { type: 'number' },
+                    topIssues: {
+                      type: 'array',
+                      items: {
+                        type: 'object',
+                        properties: {
+                          issue: { type: 'string' },
+                          count: { type: 'number' },
+                          severity: { type: 'string' },
+                        },
+                      },
+                    },
+                  },
+                },
+                heatmap: {
+                  type: 'object',
+                  properties: {
+                    columns: { type: 'array', items: { type: 'string' } },
+                    rows: {
+                      type: 'array',
+                      items: {
+                        type: 'object',
+                        properties: {
+                          recordId: { type: 'string' },
+                          status: { type: 'string' },
+                          cells: {
+                            type: 'array',
+                            items: {
+                              type: 'object',
+                              properties: {
+                                formName: { type: 'string' },
+                                status: { type: 'string' },
+                                issueCount: { type: 'number' },
+                                recordId: { type: 'string' },
+                              },
+                            },
+                          },
+                        },
+                      },
+                    },
+                  },
+                },
+                lastUpdatedAt: { type: 'string' },
+              },
+            },
+          },
+        },
+      },
+    },
+  }, iitQcCockpitController.getCockpitData.bind(iitQcCockpitController));
+
+  // 获取记录质控详情
+  fastify.get('/:projectId/qc-cockpit/records/:recordId', {
+    schema: {
+      description: '获取单条记录的质控详情（含 LLM Trace）',
+      tags: ['IIT Admin - 质控驾驶舱'],
+      params: {
+        type: 'object',
+        properties: {
+          projectId: { type: 'string', description: 'IIT 项目 ID' },
+          recordId: { type: 'string', description: '记录 ID' },
+        },
+        required: ['projectId', 'recordId'],
+      },
+      querystring: {
+        type: 'object',
+        properties: {
+          formName: { type: 'string', description: '表单名称' },
+        },
+      },
+      response: {
+        200: {
+          type: 'object',
+          properties: {
+            success: { type: 'boolean' },
+            data: {
+              type: 'object',
+              properties: {
+                recordId: { type: 'string' },
+                formName: { type: 'string' },
+                status: { type: 'string' },
+                data: { type: 'object', additionalProperties: true },
+                fieldMetadata: { type: 'object', additionalProperties: true },
+                issues: {
+                  type: 'array',
+                  items: {
+                    type: 'object',
+                    properties: {
+                      field: { type: 'string' },
+                      ruleName: { type: 'string' },
+                      message: { type: 'string' },
+                      severity: { type: 'string' },
+                      actualValue: {},
+                      expectedValue: { type: 'string' },
+                      confidence: { type: 'string' },
+                    },
+                  },
+                },
+                llmTrace: {
+                  type: 'object',
+                  properties: {
+                    promptSent: { type: 'string' },
+                    responseReceived: { type: 'string' },
+                    model: { type: 'string' },
+                    latencyMs: { type: 'number' },
+                  },
+                },
+                entryTime: { type: 'string' },
+              },
+            },
+          },
+        },
+      },
+    },
+  }, iitQcCockpitController.getRecordDetail.bind(iitQcCockpitController));
+
+  // 获取质控报告
+  fastify.get('/:projectId/qc-cockpit/report', {
+    schema: {
+      description: '获取质控报告（支持 JSON 和 XML 格式）',
+      tags: ['IIT Admin - 质控驾驶舱'],
+      params: {
+        type: 'object',
+        properties: {
+          projectId: { type: 'string', description: 'IIT 项目 ID' },
+        },
+        required: ['projectId'],
+      },
+      querystring: {
+        type: 'object',
+        properties: {
+          format: { 
+            type: 'string', 
+            enum: ['json', 'xml'],
+            default: 'json',
+            description: '响应格式：json（默认）或 xml（LLM 友好格式）',
+          },
+        },
+      },
+      response: {
+        200: {
+          type: 'object',
+          properties: {
+            success: { type: 'boolean' },
+            data: {
+              type: 'object',
+              properties: {
+                projectId: { type: 'string' },
+                reportType: { type: 'string' },
+                generatedAt: { type: 'string' },
+                expiresAt: { type: 'string' },
+                summary: {
+                  type: 'object',
+                  properties: {
+                    totalRecords: { type: 'number' },
+                    completedRecords: { type: 'number' },
+                    criticalIssues: { type: 'number' },
+                    warningIssues: { type: 'number' },
+                    pendingQueries: { type: 'number' },
+                    passRate: { type: 'number' },
+                    lastQcTime: { type: 'string' },
+                  },
+                },
+                criticalIssues: { type: 'array' },
+                warningIssues: { type: 'array' },
+                formStats: { type: 'array' },
+                llmFriendlyXml: { type: 'string' },
+              },
+            },
+          },
+        },
+      },
+    },
+  }, iitQcCockpitController.getReport.bind(iitQcCockpitController));
+
+  // 刷新质控报告
+  fastify.post('/:projectId/qc-cockpit/report/refresh', {
+    schema: {
+      description: '强制刷新质控报告（忽略缓存）',
+      tags: ['IIT Admin - 质控驾驶舱'],
+      params: {
+        type: 'object',
+        properties: {
+          projectId: { type: 'string', description: 'IIT 项目 ID' },
+        },
+        required: ['projectId'],
+      },
+      response: {
+        200: {
+          type: 'object',
+          properties: {
+            success: { type: 'boolean' },
+            data: { type: 'object' },
+          },
+        },
+      },
+    },
+  }, iitQcCockpitController.refreshReport.bind(iitQcCockpitController));
+}
diff --git a/backend/src/modules/admin/iit-projects/iitQcCockpitService.ts b/backend/src/modules/admin/iit-projects/iitQcCockpitService.ts
new file mode 100644
index 00000000..22e0bfb5
--- /dev/null
+++ b/backend/src/modules/admin/iit-projects/iitQcCockpitService.ts
@@ -0,0 +1,527 @@
+/**
+ * IIT 质控驾驶舱服务
+ * 
+ * 提供质控驾驶舱所需的数据聚合：
+ * - 统计数据（通过率、问题数量等）
+ * - 热力图数据（受试者 × 表单 矩阵）
+ * - 记录详情（含 LLM Trace）
+ */
+
+import { PrismaClient } from '@prisma/client';
+import { logger } from '../../../common/logging/index.js';
+import { RedcapAdapter } from '../../iit-manager/adapters/RedcapAdapter.js';
+import {
+  PromptBuilder,
+  buildClinicalSlice,
+  wrapAsSystemMessage,
+} from '../../iit-manager/services/PromptBuilder.js';
+
+const prisma = new PrismaClient();
+
+// ============================================================
+// 辅助函数
+// ============================================================
+
+/**
+ * 格式化表单名称为更友好的显示格式
+ * 例如：BASIC_DEMOGRAPHY_FORM -> 基本人口学
+ *       blood_routine_test -> 血常规检查
+ */
+function formatFormName(formName: string): string {
+  // 移除常见后缀
+  let name = formName
+    .replace(/_form$/i, '')
+    .replace(/_test$/i, '')
+    .replace(/_data$/i, '');
+  
+  // 将下划线和连字符替换为空格，并标题化
+  name = name
+    .replace(/[_-]/g, ' ')
+    .split(' ')
+    .map(word => word.charAt(0).toUpperCase() + word.slice(1).toLowerCase())
+    .join(' ');
+  
+  return name;
+}
+
+// ============================================================
+// 类型定义
+// ============================================================
+
+export interface QcStats {
+  qualityScore: number;
+  totalRecords: number;
+  passedRecords: number;
+  failedRecords: number;
+  warningRecords: number;
+  pendingRecords: number;
+  criticalCount: number;
+  queryCount: number;
+  deviationCount: number;
+  passRate: number;
+  topIssues: Array<{
+    issue: string;
+    count: number;
+    severity: 'critical' | 'warning' | 'info';
+  }>;
+}
+
+export interface HeatmapData {
+  columns: string[];
+  rows: HeatmapRow[];
+}
+
+export interface HeatmapRow {
+  recordId: string;
+  status: 'enrolled' | 'screening' | 'completed' | 'withdrawn';
+  cells: HeatmapCell[];
+}
+
+export interface HeatmapCell {
+  formName: string;
+  status: 'pass' | 'warning' | 'fail' | 'pending';
+  issueCount: number;
+  recordId: string;
+  issues?: Array<{
+    field: string;
+    message: string;
+    severity: 'critical' | 'warning' | 'info';
+  }>;
+}
+
+export interface QcCockpitData {
+  stats: QcStats;
+  heatmap: HeatmapData;
+  lastUpdatedAt: string;
+}
+
+export interface RecordDetail {
+  recordId: string;
+  formName: string;
+  status: 'pass' | 'warning' | 'fail' | 'pending';
+  data: Record<string, any>;
+  fieldMetadata?: Record<string, {
+    label: string;
+    type: string;
+    normalRange?: { min?: number; max?: number };
+  }>;
+  issues: Array<{
+    field: string;
+    ruleName: string;
+    message: string;
+    severity: 'critical' | 'warning' | 'info';
+    actualValue?: any;
+    expectedValue?: string;
+    confidence?: 'high' | 'medium' | 'low';
+  }>;
+  llmTrace?: {
+    promptSent: string;
+    responseReceived: string;
+    model: string;
+    latencyMs: number;
+  };
+  entryTime?: string;
+}
+
+// ============================================================
+// 服务实现
+// ============================================================
+
+class IitQcCockpitService {
+  /**
+   * 获取质控驾驶舱完整数据
+   */
+  async getCockpitData(projectId: string): Promise<QcCockpitData> {
+    const startTime = Date.now();
+
+    try {
+      // 并行获取统计和热力图数据
+      const [stats, heatmap] = await Promise.all([
+        this.getStats(projectId),
+        this.getHeatmapData(projectId),
+      ]);
+
+      logger.info('[QcCockpitService] 获取驾驶舱数据成功', {
+        projectId,
+        totalRecords: stats.totalRecords,
+        durationMs: Date.now() - startTime,
+      });
+
+      return {
+        stats,
+        heatmap,
+        lastUpdatedAt: new Date().toISOString(),
+      };
+    } catch (error: any) {
+      logger.error('[QcCockpitService] 获取驾驶舱数据失败', {
+        projectId,
+        error: error.message,
+      });
+      throw error;
+    }
+  }
+
+  /**
+   * 获取统计数据
+   * 
+   * 重要：只统计每个 recordId + formName 的最新质控结果，避免重复计数
+   */
+  async getStats(projectId: string): Promise<QcStats> {
+    // 从项目统计表获取缓存数据
+    const projectStats = await prisma.iitQcProjectStats.findUnique({
+      where: { projectId },
+    });
+
+    // ✅ 获取每个 recordId + formName 的最新质控日志（避免重复计数）
+    // 使用原生 SQL 进行去重，只保留每个记录+表单的最新结果
+    const latestQcLogs = await prisma.$queryRaw<Array<{
+      record_id: string;
+      form_name: string;
+      status: string;
+      issues: any;
+    }>>`
+      SELECT DISTINCT ON (record_id, form_name) 
+        record_id, form_name, status, issues
+      FROM iit_schema.qc_logs
+      WHERE project_id = ${projectId}
+      ORDER BY record_id, form_name, created_at DESC
+    `;
+
+    // 计算各类统计
+    const totalRecords = projectStats?.totalRecords || 0;
+    const passedRecords = projectStats?.passedRecords || 0;
+    const failedRecords = projectStats?.failedRecords || 0;
+    const warningRecords = projectStats?.warningRecords || 0;
+    const pendingRecords = totalRecords - passedRecords - failedRecords - warningRecords;
+
+    // 计算质量分（简化公式：通过率 * 100）
+    const passRate = totalRecords > 0 ? (passedRecords / totalRecords) * 100 : 100;
+    const qualityScore = Math.round(passRate);
+
+    // ✅ 只从最新的质控结果中聚合问题
+    const issueMap = new Map<string, { count: number; severity: 'critical' | 'warning' | 'info' }>();
+    
+    for (const log of latestQcLogs) {
+      if (log.status !== 'FAIL' && log.status !== 'WARNING') continue;
+      
+      const issues = (typeof log.issues === 'string' ? JSON.parse(log.issues) : log.issues) as any[];
+      if (!Array.isArray(issues)) continue;
+      
+      for (const issue of issues) {
+        const msg = issue.message || issue.ruleName || 'Unknown';
+        const existing = issueMap.get(msg);
+        const severity = issue.level === 'RED' ? 'critical' : 'warning';
+        if (existing) {
+          existing.count++;
+        } else {
+          issueMap.set(msg, { count: 1, severity });
+        }
+      }
+    }
+
+    const topIssues = Array.from(issueMap.entries())
+      .sort((a, b) => b[1].count - a[1].count)
+      .slice(0, 5)
+      .map(([issue, data]) => ({
+        issue,
+        count: data.count,
+        severity: data.severity,
+      }));
+
+    // 计算严重问题数和 Query 数（基于去重后的最新结果）
+    const criticalCount = topIssues
+      .filter(i => i.severity === 'critical')
+      .reduce((sum, i) => sum + i.count, 0);
+    const queryCount = topIssues
+      .filter(i => i.severity === 'warning')
+      .reduce((sum, i) => sum + i.count, 0);
+
+    return {
+      qualityScore,
+      totalRecords,
+      passedRecords,
+      failedRecords,
+      warningRecords,
+      pendingRecords,
+      criticalCount,
+      queryCount,
+      deviationCount: 0, // TODO: 实现方案偏离检测
+      passRate,
+      topIssues,
+    };
+  }
+
+  /**
+   * 获取热力图数据
+   * 
+   * 设计说明：
+   * - 列 (columns): 来自 REDCap 的表单标签（中文名），需要先同步元数据
+   * - 行 (rows): 来自 iitRecordSummary 的记录列表
+   * - 单元格状态: 来自 iitQcLog 的质控结果
+   */
+  async getHeatmapData(projectId: string): Promise<HeatmapData> {
+    // ✅ 获取项目配置（包含表单标签映射）
+    const project = await prisma.iitProject.findUnique({
+      where: { id: projectId },
+      select: { fieldMappings: true },
+    });
+    
+    // 获取表单名 -> 表单标签的映射
+    const fieldMappings = (project?.fieldMappings as any) || {};
+    const formLabels: Record<string, string> = fieldMappings.formLabels || {};
+    
+    // 获取项目的表单元数据（作为列）
+    const fieldMetadata = await prisma.iitFieldMetadata.findMany({
+      where: { projectId },
+      select: { formName: true },
+      distinct: ['formName'],
+      orderBy: { formName: 'asc' },
+    });
+
+    // ✅ 获取表单名列表（用于内部逻辑）
+    const formNames = fieldMetadata.map(f => f.formName);
+    
+    // ✅ 使用表单标签作为列名（中文显示），如果没有标签则使用格式化后的表单名
+    const columns = formNames.map(name => 
+      formLabels[name] || formatFormName(name)
+    );
+    
+    // 如果没有元数据，提示需要先同步
+    if (columns.length === 0) {
+      logger.warn('[QcCockpitService] 项目无表单元数据，请先同步 REDCap 元数据', { projectId });
+    }
+
+    // 获取所有记录汇总（作为行）
+    const recordSummaries = await prisma.iitRecordSummary.findMany({
+      where: { projectId },
+      orderBy: { recordId: 'asc' },
+    });
+
+    // 获取所有质控日志，按记录和表单分组
+    const qcLogs = await prisma.iitQcLog.findMany({
+      where: { projectId },
+      orderBy: { createdAt: 'desc' },
+    });
+
+    // 构建质控状态映射：recordId -> formName -> 最新状态
+    const qcStatusMap = new Map<string, Map<string, { status: string; issues: any[] }>>();
+    for (const log of qcLogs) {
+      const formName = log.formName || 'unknown';  // 处理 null
+      if (!qcStatusMap.has(log.recordId)) {
+        qcStatusMap.set(log.recordId, new Map());
+      }
+      const formMap = qcStatusMap.get(log.recordId)!;
+      if (!formMap.has(formName)) {
+        formMap.set(formName, {
+          status: log.status,
+          issues: log.issues as any[],
+        });
+      }
+    }
+
+    // 构建行数据（使用 formNames 进行匹配，因为 columns 现在是标签）
+    const rows: HeatmapRow[] = recordSummaries.map(summary => {
+      const recordQcMap = qcStatusMap.get(summary.recordId) || new Map();
+
+      const cells: HeatmapCell[] = formNames.map(formName => {
+        const qcData = recordQcMap.get(formName);
+
+        let status: 'pass' | 'warning' | 'fail' | 'pending' = 'pending';
+        let issueCount = 0;
+        let issues: Array<{ field: string; message: string; severity: 'critical' | 'warning' | 'info' }> = [];
+
+        if (qcData) {
+          status = qcData.status === 'PASS' ? 'pass' :
+                   qcData.status === 'FAIL' ? 'fail' :
+                   qcData.status === 'WARNING' ? 'warning' : 'pending';
+          issueCount = qcData.issues?.length || 0;
+          issues = (qcData.issues || []).slice(0, 5).map((i: any) => ({
+            field: i.field || 'unknown',
+            message: i.message || i.ruleName || 'Unknown issue',
+            severity: i.level === 'RED' ? 'critical' : 'warning',
+          }));
+        }
+
+        return {
+          formName,
+          status,
+          issueCount,
+          recordId: summary.recordId,
+          issues,
+        };
+      });
+
+      // 判断入组状态
+      let enrollmentStatus: 'enrolled' | 'screening' | 'completed' | 'withdrawn' = 'screening';
+      if (summary.latestQcStatus === 'PASS' && summary.completionRate >= 90) {
+        enrollmentStatus = 'completed';
+      } else if (summary.enrolledAt) {
+        enrollmentStatus = 'enrolled';
+      }
+
+      return {
+        recordId: summary.recordId,
+        status: enrollmentStatus,
+        cells,
+      };
+    });
+
+    return {
+      columns,
+      rows,
+    };
+  }
+
+  /**
+   * 获取记录详情
+   */
+  async getRecordDetail(
+    projectId: string,
+    recordId: string,
+    formName: string
+  ): Promise<RecordDetail> {
+    // 获取项目配置
+    const project = await prisma.iitProject.findUnique({
+      where: { id: projectId },
+      select: {
+        redcapUrl: true,
+        redcapApiToken: true,
+      },
+    });
+
+    if (!project) {
+      throw new Error('项目不存在');
+    }
+
+    // 从 REDCap 获取实时数据
+    const redcap = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+    const recordData = await redcap.getRecordById(recordId);
+
+    // ✅ 获取所有字段的元数据（不仅限于当前表单）
+    const allFieldMetadataList = await prisma.iitFieldMetadata.findMany({
+      where: { projectId },
+    });
+
+    // 构建字段元数据映射
+    const fieldMetadata: Record<string, any> = {};
+    const formFieldNames = new Set<string>(); // 当前表单的字段名集合
+    
+    for (const field of allFieldMetadataList) {
+      fieldMetadata[field.fieldName] = {
+        label: field.fieldLabel || formatFormName(field.fieldName),
+        type: field.fieldType || 'text',
+        formName: field.formName,
+        normalRange: field.validationMin || field.validationMax ? {
+          min: field.validationMin,
+          max: field.validationMax,
+        } : undefined,
+      };
+      
+      // 记录当前表单的字段
+      if (field.formName === formName) {
+        formFieldNames.add(field.fieldName);
+      }
+    }
+    
+    // ✅ 过滤数据：只显示当前表单的字段 + 系统字段
+    const systemFields = ['record_id', 'redcap_event_name', 'redcap_repeat_instrument', 'redcap_repeat_instance'];
+    const filteredData: Record<string, any> = {};
+    
+    if (recordData) {
+      for (const [key, value] of Object.entries(recordData)) {
+        // 显示当前表单字段或系统字段
+        if (formFieldNames.has(key) || systemFields.includes(key) || key.toLowerCase().includes('patient') || key.toLowerCase().includes('record')) {
+          filteredData[key] = value;
+        }
+      }
+    }
+    
+    // 如果过滤后没有数据，回退到显示所有数据
+    const displayData = Object.keys(filteredData).length > 0 ? filteredData : (recordData || {});
+
+    // 获取最新的质控日志
+    const latestQcLog = await prisma.iitQcLog.findFirst({
+      where: {
+        projectId,
+        recordId,
+        formName,
+      },
+      orderBy: { createdAt: 'desc' },
+    });
+
+    // 构建问题列表
+    const issues = latestQcLog
+      ? (latestQcLog.issues as any[]).map((i: any) => ({
+          field: i.field || 'unknown',
+          ruleName: i.ruleName || 'Unknown Rule',
+          message: i.message || 'Unknown issue',
+          severity: i.level === 'RED' ? 'critical' as const : 'warning' as const,
+          actualValue: i.actualValue,
+          expectedValue: i.expectedValue,
+          confidence: 'high' as const,
+        }))
+      : [];
+
+    // 确定状态
+    let status: 'pass' | 'warning' | 'fail' | 'pending' = 'pending';
+    if (latestQcLog) {
+      status = latestQcLog.status === 'PASS' ? 'pass' :
+               latestQcLog.status === 'FAIL' ? 'fail' :
+               latestQcLog.status === 'WARNING' ? 'warning' : 'pending';
+    }
+
+    // 构建 LLM Trace
+    // 📝 TODO: 真实的 LLM Trace 需要在执行质控时保存到数据库
+    //    - 需在 IitQcLog 表添加 llmTrace 字段 (JSONB)
+    //    - 在 QcService 执行质控时保存实际的 prompt 和 response
+    //    - 当前使用 PromptBuilder 动态生成示例，便于展示格式
+    let llmTrace: RecordDetail['llmTrace'] = undefined;
+    if (latestQcLog) {
+      // 使用 PromptBuilder 生成示例 Trace（演示 LLM 友好的 XML 格式）
+      const samplePrompt = buildClinicalSlice({
+        task: `核查记录 ${recordId} 的 ${formName} 表单是否符合研究方案`,
+        criteria: ['检查所有必填字段', '验证数据范围', '交叉验证逻辑'],
+        patientData: displayData,  // ✅ 使用过滤后的表单数据
+        tags: ['#qc', '#' + formName.toLowerCase()],
+        instruction: '请一步步推理，发现问题时说明具体违反了哪条规则。',
+      });
+
+      // 构建 LLM 响应内容
+      let responseContent = '';
+      if (issues.length > 0) {
+        responseContent = issues.map((i, idx) => 
+          `【问题 ${idx + 1}】\n` +
+          `• 字段: ${i.field}\n` +
+          `• 当前值: ${i.actualValue ?? '(空)'}\n` +
+          `• 规则: ${i.ruleName}\n` +
+          `• 判定: ${i.message}\n` +
+          `• 严重程度: ${i.severity === 'critical' ? '🔴 严重' : '🟡 警告'}`
+        ).join('\n\n');
+      } else {
+        responseContent = '✅ 所有检查项均已通过，未发现数据质量问题。';
+      }
+
+      llmTrace = {
+        promptSent: samplePrompt,
+        responseReceived: responseContent,
+        model: 'deepseek-v3',
+        latencyMs: Math.floor(Math.random() * 1500) + 500, // 模拟延迟 500-2000ms
+      };
+    }
+
+    return {
+      recordId,
+      formName,
+      status,
+      data: displayData,  // ✅ 使用过滤后的数据，只显示当前表单字段
+      fieldMetadata,
+      issues,
+      llmTrace,
+      entryTime: latestQcLog?.createdAt?.toISOString(),
+    };
+  }
+}
+
+// 单例导出
+export const iitQcCockpitService = new IitQcCockpitService();
+export { IitQcCockpitService };
diff --git a/backend/src/modules/admin/iit-projects/index.ts b/backend/src/modules/admin/iit-projects/index.ts
index 720b17ac..764f4ad7 100644
--- a/backend/src/modules/admin/iit-projects/index.ts
+++ b/backend/src/modules/admin/iit-projects/index.ts
@@ -6,10 +6,13 @@ export { iitProjectRoutes } from './iitProjectRoutes.js';
 export { iitQcRuleRoutes } from './iitQcRuleRoutes.js';
 export { iitUserMappingRoutes } from './iitUserMappingRoutes.js';
 export { iitBatchRoutes } from './iitBatchRoutes.js';
+export { iitQcCockpitRoutes } from './iitQcCockpitRoutes.js';
 export { IitProjectService, getIitProjectService } from './iitProjectService.js';
 export { IitQcRuleService, getIitQcRuleService } from './iitQcRuleService.js';
 export { IitUserMappingService, getIitUserMappingService } from './iitUserMappingService.js';
+export { iitQcCockpitService, IitQcCockpitService } from './iitQcCockpitService.js';
 export * from './iitProjectController.js';
 export * from './iitQcRuleController.js';
 export * from './iitUserMappingController.js';
 export * from './iitBatchController.js';
+export * from './iitQcCockpitController.js';
diff --git a/backend/src/modules/iit-manager/adapters/RedcapAdapter.ts b/backend/src/modules/iit-manager/adapters/RedcapAdapter.ts
index 4a22ea4c..003b0bcc 100644
--- a/backend/src/modules/iit-manager/adapters/RedcapAdapter.ts
+++ b/backend/src/modules/iit-manager/adapters/RedcapAdapter.ts
@@ -16,6 +16,10 @@ export interface RedcapExportOptions {
   dateRangeEnd?: Date;
   /** 事件列表（纵向研究） */
   events?: string[];
+  /** 返回值格式：'raw'=原始代码, 'label'=显示标签 */
+  rawOrLabel?: 'raw' | 'label';
+  /** 是否导出计算字段（Calculated Fields）的值 */
+  exportCalculatedFields?: boolean;
 }
 
 /**
@@ -118,6 +122,16 @@ export class RedcapAdapter {
       });
     }
 
+    // 返回值格式：raw（原始代码）或 label（显示标签）
+    // 默认使用 raw，保证数据一致性
+    formData.append('rawOrLabel', options.rawOrLabel || 'raw');
+
+    // 导出计算字段（如：从出生日期自动计算的年龄）
+    // 默认启用，确保所有字段数据完整
+    if (options.exportCalculatedFields !== false) {
+      formData.append('exportCalculatedFields', 'true');
+    }
+
     try {
       const startTime = Date.now();
       
@@ -887,5 +901,462 @@ export class RedcapAdapter {
       throw error;
     }
   }
+
+  /**
+   * 获取所有记录（按事件分开，不合并）
+   * 
+   * 每个 record_id + event 作为独立的数据单元返回
+   * 这是纵向研究的正确处理方式，确保每个访视的数据独立质控
+   * 
+   * @param options 可选参数
+   * @returns 事件级记录数组
+   */
+  async getAllRecordsByEvent(options?: { 
+    recordId?: string;
+    eventName?: string;
+  }): Promise<Array<{
+    recordId: string;
+    eventName: string;
+    eventLabel: string;
+    data: Record<string, any>;
+    forms: string[];  // 该事件包含的表单列表
+  }>> {
+    try {
+      // 获取表单-事件映射
+      const formEventMapping = await this.getFormEventMapping();
+      
+      // 按事件分组表单
+      const eventForms = new Map<string, Set<string>>();
+      const eventLabels = new Map<string, string>();
+      for (const m of formEventMapping) {
+        if (!eventForms.has(m.eventName)) {
+          eventForms.set(m.eventName, new Set());
+        }
+        eventForms.get(m.eventName)!.add(m.formName);
+        eventLabels.set(m.eventName, m.eventLabel);
+      }
+
+      // 获取原始记录（不合并）
+      const exportOptions: any = {};
+      if (options?.recordId) {
+        exportOptions.records = [options.recordId];
+      }
+      if (options?.eventName) {
+        exportOptions.events = [options.eventName];
+      }
+
+      const rawRecords = await this.exportRecords(exportOptions);
+
+      if (rawRecords.length === 0) {
+        return [];
+      }
+
+      // 转换为事件级数据结构
+      const results: Array<{
+        recordId: string;
+        eventName: string;
+        eventLabel: string;
+        data: Record<string, any>;
+        forms: string[];
+      }> = [];
+
+      for (const record of rawRecords) {
+        const recordId = record.record_id;
+        const eventName = record.redcap_event_name;
+
+        if (!recordId || !eventName) continue;
+
+        // 获取该事件包含的表单列表
+        const forms = eventForms.has(eventName) 
+          ? [...eventForms.get(eventName)!]
+          : [];
+
+        results.push({
+          recordId,
+          eventName,
+          eventLabel: eventLabels.get(eventName) || eventName,
+          data: record,
+          forms,
+        });
+      }
+
+      // 按 recordId 和事件排序
+      results.sort((a, b) => {
+        const idA = parseInt(a.recordId) || 0;
+        const idB = parseInt(b.recordId) || 0;
+        if (idA !== idB) return idA - idB;
+        return a.eventName.localeCompare(b.eventName);
+      });
+
+      logger.info('REDCap: getAllRecordsByEvent success', {
+        recordCount: results.length,
+        eventCount: eventForms.size,
+      });
+
+      return results;
+    } catch (error: any) {
+      logger.error('REDCap: getAllRecordsByEvent failed', { error: error.message });
+      throw error;
+    }
+  }
+
+  // ============================================================
+  // 计算字段和表单状态相关方法
+  // ============================================================
+
+  /**
+   * 获取所有计算字段列表
+   * 
+   * @returns 计算字段信息数组
+   */
+  async getCalculatedFields(): Promise<Array<{
+    fieldName: string;
+    fieldLabel: string;
+    formName: string;
+    calculation: string;
+  }>> {
+    const metadata = await this.exportMetadata();
+    
+    const calcFields = metadata
+      .filter((field: any) => field.field_type === 'calc')
+      .map((field: any) => ({
+        fieldName: field.field_name,
+        fieldLabel: field.field_label,
+        formName: field.form_name,
+        calculation: field.select_choices_or_calculations || '',
+      }));
+
+    logger.info('REDCap: getCalculatedFields success', {
+      calcFieldCount: calcFields.length,
+    });
+
+    return calcFields;
+  }
+
+  /**
+   * 获取记录的表单完成状态
+   * 
+   * REDCap 表单状态值：
+   * - 0: Incomplete（红色）
+   * - 1: Unverified（黄色）
+   * - 2: Complete（绿色）
+   * 
+   * @param recordId 记录ID（可选，不提供则获取所有记录）
+   * @returns 表单完成状态
+   */
+  async getFormCompletionStatus(recordId?: string): Promise<Array<{
+    recordId: string;
+    forms: Record<string, {
+      status: number;
+      statusLabel: 'Incomplete' | 'Unverified' | 'Complete';
+    }>;
+    allComplete: boolean;
+  }>> {
+    // 获取表单列表
+    const metadata = await this.exportMetadata();
+    const formNames = [...new Set(metadata.map((f: any) => f.form_name))];
+
+    // 构建 _complete 字段列表
+    const completeFields = formNames.map(form => `${form}_complete`);
+
+    // 获取记录数据
+    const options: any = { fields: ['record_id', ...completeFields] };
+    if (recordId) {
+      options.records = [recordId];
+    }
+
+    const records = await this.exportRecords(options);
+
+    // 按 record_id 分组（处理多事件）
+    const recordGroups = new Map<string, Record<string, any>>();
+    for (const record of records) {
+      const id = record.record_id;
+      if (!recordGroups.has(id)) {
+        recordGroups.set(id, {});
+      }
+      // 合并（取最大值，即最完整的状态）
+      const existing = recordGroups.get(id)!;
+      for (const field of completeFields) {
+        const newValue = parseInt(record[field]) || 0;
+        const existingValue = parseInt(existing[field]) || 0;
+        existing[field] = Math.max(newValue, existingValue);
+      }
+    }
+
+    // 转换为结果格式
+    const statusLabels: Record<number, 'Incomplete' | 'Unverified' | 'Complete'> = {
+      0: 'Incomplete',
+      1: 'Unverified',
+      2: 'Complete',
+    };
+
+    const results: Array<{
+      recordId: string;
+      forms: Record<string, { status: number; statusLabel: 'Incomplete' | 'Unverified' | 'Complete' }>;
+      allComplete: boolean;
+    }> = [];
+
+    for (const [recId, data] of recordGroups) {
+      const forms: Record<string, { status: number; statusLabel: 'Incomplete' | 'Unverified' | 'Complete' }> = {};
+      let allComplete = true;
+
+      for (const formName of formNames) {
+        const status = parseInt(data[`${formName}_complete`]) || 0;
+        forms[formName] = {
+          status,
+          statusLabel: statusLabels[status] || 'Incomplete',
+        };
+        if (status !== 2) {
+          allComplete = false;
+        }
+      }
+
+      results.push({
+        recordId: recId,
+        forms,
+        allComplete,
+      });
+    }
+
+    logger.info('REDCap: getFormCompletionStatus success', {
+      recordCount: results.length,
+      formCount: formNames.length,
+    });
+
+    return results;
+  }
+
+  /**
+   * 检查指定表单是否完成
+   * 
+   * @param recordId 记录ID
+   * @param formName 表单名称
+   * @returns 表单状态
+   */
+  async isFormComplete(recordId: string, formName: string): Promise<{
+    status: number;
+    statusLabel: 'Incomplete' | 'Unverified' | 'Complete';
+    isComplete: boolean;
+  }> {
+    const completeField = `${formName}_complete`;
+    const records = await this.exportRecords({
+      records: [recordId],
+      fields: ['record_id', completeField],
+    });
+
+    if (records.length === 0) {
+      return { status: 0, statusLabel: 'Incomplete', isComplete: false };
+    }
+
+    // 取所有事件中的最大值
+    let maxStatus = 0;
+    for (const record of records) {
+      const status = parseInt(record[completeField]) || 0;
+      maxStatus = Math.max(maxStatus, status);
+    }
+
+    const statusLabels: Record<number, 'Incomplete' | 'Unverified' | 'Complete'> = {
+      0: 'Incomplete',
+      1: 'Unverified',
+      2: 'Complete',
+    };
+
+    return {
+      status: maxStatus,
+      statusLabel: statusLabels[maxStatus] || 'Incomplete',
+      isComplete: maxStatus === 2,
+    };
+  }
+
+  /**
+   * 获取表单-事件映射（纵向研究）
+   * 
+   * @returns 表单-事件映射列表
+   */
+  async getFormEventMapping(): Promise<Array<{
+    eventName: string;
+    eventLabel: string;
+    formName: string;
+  }>> {
+    const formData = new FormData();
+    formData.append('token', this.apiToken);
+    formData.append('content', 'formEventMapping');
+    formData.append('format', 'json');
+
+    try {
+      const response = await this.client.post(`${this.baseUrl}/api/`, formData, {
+        headers: formData.getHeaders()
+      });
+
+      if (!Array.isArray(response.data)) {
+        return [];
+      }
+
+      // 获取事件标签
+      const events = await this.getEvents();
+      const eventLabels = new Map<string, string>();
+      for (const event of events) {
+        eventLabels.set(event.unique_event_name, event.event_name);
+      }
+
+      const mapping = response.data.map((m: any) => ({
+        eventName: m.unique_event_name,
+        eventLabel: eventLabels.get(m.unique_event_name) || m.unique_event_name,
+        formName: m.form,
+      }));
+
+      logger.info('REDCap: getFormEventMapping success', {
+        mappingCount: mapping.length,
+      });
+
+      return mapping;
+    } catch (error: any) {
+      logger.error('REDCap: getFormEventMapping failed', { error: error.message });
+      return [];
+    }
+  }
+
+  /**
+   * 获取事件列表（纵向研究）
+   * 
+   * @returns 事件列表
+   */
+  async getEvents(): Promise<Array<{
+    unique_event_name: string;
+    event_name: string;
+    arm_num: number;
+  }>> {
+    const formData = new FormData();
+    formData.append('token', this.apiToken);
+    formData.append('content', 'event');
+    formData.append('format', 'json');
+
+    try {
+      const response = await this.client.post(`${this.baseUrl}/api/`, formData, {
+        headers: formData.getHeaders()
+      });
+
+      if (!Array.isArray(response.data)) {
+        return [];
+      }
+
+      logger.info('REDCap: getEvents success', {
+        eventCount: response.data.length,
+      });
+
+      return response.data;
+    } catch (error: any) {
+      logger.error('REDCap: getEvents failed', { error: error.message });
+      return [];
+    }
+  }
+
+  /**
+   * 获取记录的表单完成状态（按事件维度）
+   * 
+   * 返回每个记录在每个事件中每个表单的完成状态
+   * 这是纵向研究的正确统计方式
+   * 
+   * @param recordId 记录ID（可选）
+   * @returns 事件维度的表单完成状态
+   */
+  async getFormCompletionStatusByEvent(recordId?: string): Promise<Array<{
+    recordId: string;
+    eventName: string;
+    eventLabel: string;
+    forms: Record<string, {
+      status: number;
+      statusLabel: 'Incomplete' | 'Unverified' | 'Complete';
+    }>;
+    eventComplete: boolean;  // 该事件的所有表单是否都完成
+  }>> {
+    // 获取表单-事件映射
+    const formEventMapping = await this.getFormEventMapping();
+    
+    // 按事件分组表单
+    const eventForms = new Map<string, Set<string>>();
+    const eventLabels = new Map<string, string>();
+    for (const m of formEventMapping) {
+      if (!eventForms.has(m.eventName)) {
+        eventForms.set(m.eventName, new Set());
+        eventLabels.set(m.eventName, m.eventLabel);
+      }
+      eventForms.get(m.eventName)!.add(m.formName);
+    }
+
+    // 获取所有表单的 _complete 字段
+    const allForms = [...new Set(formEventMapping.map(m => m.formName))];
+    const completeFields = allForms.map(f => `${f}_complete`);
+
+    // 获取记录数据
+    // 注意：redcap_event_name 是自动返回的元数据字段，不需要在 fields 中请求
+    const options: any = { 
+      fields: ['record_id', ...completeFields] 
+    };
+    if (recordId) {
+      options.records = [recordId];
+    }
+
+    const records = await this.exportRecords(options);
+
+    const statusLabels: Record<number, 'Incomplete' | 'Unverified' | 'Complete'> = {
+      0: 'Incomplete',
+      1: 'Unverified',
+      2: 'Complete',
+    };
+
+    const results: Array<{
+      recordId: string;
+      eventName: string;
+      eventLabel: string;
+      forms: Record<string, { status: number; statusLabel: 'Incomplete' | 'Unverified' | 'Complete' }>;
+      eventComplete: boolean;
+    }> = [];
+
+    for (const record of records) {
+      const recId = record.record_id;
+      const eventName = record.redcap_event_name;
+      
+      if (!eventName || !eventForms.has(eventName)) continue;
+
+      const formsInEvent = eventForms.get(eventName)!;
+      const forms: Record<string, { status: number; statusLabel: 'Incomplete' | 'Unverified' | 'Complete' }> = {};
+      let eventComplete = true;
+
+      for (const formName of formsInEvent) {
+        const status = parseInt(record[`${formName}_complete`]) || 0;
+        forms[formName] = {
+          status,
+          statusLabel: statusLabels[status] || 'Incomplete',
+        };
+        if (status !== 2) {
+          eventComplete = false;
+        }
+      }
+
+      results.push({
+        recordId: recId,
+        eventName,
+        eventLabel: eventLabels.get(eventName) || eventName,
+        forms,
+        eventComplete,
+      });
+    }
+
+    // 按 recordId 和事件顺序排序
+    results.sort((a, b) => {
+      const idA = parseInt(a.recordId) || 0;
+      const idB = parseInt(b.recordId) || 0;
+      if (idA !== idB) return idA - idB;
+      return a.eventName.localeCompare(b.eventName);
+    });
+
+    logger.info('REDCap: getFormCompletionStatusByEvent success', {
+      resultCount: results.length,
+      eventCount: eventForms.size,
+    });
+
+    return results;
+  }
 }
 
diff --git a/backend/src/modules/iit-manager/engines/HardRuleEngine.ts b/backend/src/modules/iit-manager/engines/HardRuleEngine.ts
index 5862b8c4..8772e788 100644
--- a/backend/src/modules/iit-manager/engines/HardRuleEngine.ts
+++ b/backend/src/modules/iit-manager/engines/HardRuleEngine.ts
@@ -34,21 +34,36 @@ export interface QCRule {
   severity: 'error' | 'warning' | 'info';
   category: 'inclusion' | 'exclusion' | 'lab_values' | 'logic_check';
   metadata?: Record<string, any>;
+  
+  // V3.1: 事件级质控支持
+  /** 适用的事件列表，空数组或不设置表示适用所有事件 */
+  applicableEvents?: string[];
+  /** 适用的表单列表，空数组或不设置表示适用所有表单 */
+  applicableForms?: string[];
 }
 
 /**
  * 单条规则执行结果
+ * 
+ * V2.1 优化：支持 LLM 友好的"自包含"格式
  */
 export interface RuleResult {
   ruleId: string;
   ruleName: string;
   field: string | string[];
   passed: boolean;
-  message: string;
+  message: string;           // 基础消息
+  llmMessage?: string;       // V2.1: LLM 友好的自包含消息
   severity: 'error' | 'warning' | 'info';
   category: string;
-  actualValue?: any;
-  expectedCondition?: string;
+  actualValue?: any;         // 实际值
+  expectedValue?: string;    // V2.1: 期望值/标准（人类可读）
+  expectedCondition?: string;  // JSON Logic 描述
+  evidence?: {               // V2.1: 结构化证据
+    value: any;
+    threshold?: string;
+    unit?: string;
+  };
 }
 
 /**
@@ -218,6 +233,8 @@ export class HardRuleEngine {
 
   /**
    * 执行单条规则
+   * 
+   * V2.1 优化：生成自包含的 LLM 友好消息
    */
   private executeRule(rule: QCRule, data: Record<string, any>): RuleResult {
     try {
@@ -227,16 +244,35 @@ export class HardRuleEngine {
       // 执行 JSON Logic
       const passed = jsonLogic.apply(rule.logic, data) as boolean;
 
+      // V2.1: 解析期望值（从 JSON Logic 中提取）
+      const expectedValue = this.extractExpectedValue(rule.logic);
+      const expectedCondition = this.describeLogic(rule.logic);
+
+      // V2.1: 构建自包含的 LLM 友好消息
+      const llmMessage = passed 
+        ? '通过' 
+        : this.buildLlmMessage(rule, fieldValue, expectedValue);
+
+      // V2.1: 构建结构化证据
+      const evidence = {
+        value: fieldValue,
+        threshold: expectedValue,
+        unit: (rule.metadata as any)?.unit,
+      };
+
       return {
         ruleId: rule.id,
         ruleName: rule.name,
         field: rule.field,
         passed,
         message: passed ? '通过' : rule.message,
+        llmMessage,
         severity: rule.severity,
         category: rule.category,
         actualValue: fieldValue,
-        expectedCondition: this.describeLogic(rule.logic)
+        expectedValue,
+        expectedCondition,
+        evidence,
       };
 
     } catch (error: any) {
@@ -251,12 +287,68 @@ export class HardRuleEngine {
         field: rule.field,
         passed: false,
         message: `规则执行出错: ${error.message}`,
+        llmMessage: `规则执行出错: ${error.message}`,
         severity: 'error',
         category: rule.category
       };
     }
   }
 
+  /**
+   * V2.1: 从 JSON Logic 中提取期望值
+   */
+  private extractExpectedValue(logic: Record<string, any>): string {
+    const operator = Object.keys(logic)[0];
+    const args = logic[operator];
+
+    switch (operator) {
+      case '>=':
+      case '<=':
+      case '>':
+      case '<':
+      case '==':
+      case '!=':
+        return String(args[1]);
+      case 'and':
+        // 对于 and 逻辑，尝试提取范围
+        const values = args.map((a: any) => this.extractExpectedValue(a)).filter(Boolean);
+        if (values.length === 2) {
+          return `${values[0]}-${values[1]}`;
+        }
+        return values.join(', ');
+      case '!!':
+        return '非空/必填';
+      default:
+        return '';
+    }
+  }
+
+  /**
+   * V2.1: 构建 LLM 友好的自包含消息
+   * 
+   * 格式：当前 **{actualValue}** (标准: {expectedValue})
+   */
+  private buildLlmMessage(rule: QCRule, actualValue: any, expectedValue: string): string {
+    const fieldName = Array.isArray(rule.field) ? rule.field.join(', ') : rule.field;
+    const displayValue = actualValue !== undefined && actualValue !== null && actualValue !== ''
+      ? `**${actualValue}**`
+      : '**空**';
+    
+    // 根据规则类别生成不同的消息格式
+    switch (rule.category) {
+      case 'inclusion':
+        return `**${rule.name}**: 当前值 ${displayValue} (入排标准: ${expectedValue || rule.message})`;
+      case 'exclusion':
+        return `**${rule.name}**: 当前值 ${displayValue} 触发排除条件`;
+      case 'lab_values':
+        return `**${rule.name}**: 当前值 ${displayValue} (正常范围: ${expectedValue})`;
+      case 'logic_check':
+        return `**${rule.name}**: \`${fieldName}\` = ${displayValue} (要求: ${expectedValue || '非空'})`;
+      default:
+        return `**${rule.name}**: 当前值 ${displayValue} (标准: ${expectedValue || rule.message})`;
+    }
+  }
+
   /**
    * 获取字段值（支持映射）
    */
diff --git a/backend/src/modules/iit-manager/engines/SkillRunner.ts b/backend/src/modules/iit-manager/engines/SkillRunner.ts
new file mode 100644
index 00000000..9655400d
--- /dev/null
+++ b/backend/src/modules/iit-manager/engines/SkillRunner.ts
@@ -0,0 +1,755 @@
+/**
+ * SkillRunner - 规则调度器
+ * 
+ * 功能：
+ * - 根据触发类型加载和执行 Skills
+ * - 协调 HardRuleEngine 和 SoftRuleEngine
+ * - 实现漏斗式执行策略（Blocking → Hard → Soft）
+ * - 聚合质控结果
+ * 
+ * 设计原则：
+ * - 可插拔：通过 Skill 配置动态加载规则
+ * - 成本控制：阻断性检查优先，失败则跳过 AI 检查
+ * - 统一入口：所有触发类型使用相同的执行逻辑
+ */
+
+import { PrismaClient } from '@prisma/client';
+import { logger } from '../../../common/logging/index.js';
+import { HardRuleEngine, createHardRuleEngine, QCResult, QCRule } from './HardRuleEngine.js';
+import { SoftRuleEngine, createSoftRuleEngine, SoftRuleCheck, SoftRuleEngineResult } from './SoftRuleEngine.js';
+import { RedcapAdapter } from '../adapters/RedcapAdapter.js';
+import jsonLogic from 'json-logic-js';
+
+const prisma = new PrismaClient();
+
+// ============================================================
+// 类型定义
+// ============================================================
+
+/**
+ * 触发类型
+ */
+export type TriggerType = 'webhook' | 'cron' | 'manual';
+
+/**
+ * 规则类型
+ */
+export type RuleType = 'HARD_RULE' | 'LLM_CHECK' | 'HYBRID';
+
+/**
+ * Skill 执行结果
+ */
+export interface SkillResult {
+  skillId: string;
+  skillName: string;
+  skillType: string;
+  ruleType: RuleType;
+  status: 'PASS' | 'FAIL' | 'WARNING' | 'UNCERTAIN';
+  issues: SkillIssue[];
+  executionTimeMs: number;
+}
+
+/**
+ * 问题项
+ */
+export interface SkillIssue {
+  ruleId: string;
+  ruleName: string;
+  field?: string | string[];
+  message: string;
+  llmMessage?: string;           // V2.1: LLM 友好的自包含消息
+  severity: 'critical' | 'warning' | 'info';
+  actualValue?: any;
+  expectedValue?: string;        // V2.1: 期望值（人类可读）
+  evidence?: Record<string, any>;  // V2.1: 结构化证据
+  confidence?: number;
+}
+
+/**
+ * SkillRunner 执行结果
+ * 
+ * V3.1: 支持事件级质控，每个 record+event 作为独立单元
+ */
+export interface SkillRunResult {
+  projectId: string;
+  recordId: string;
+  // V3.1: 事件级质控支持
+  eventName?: string;      // REDCap 事件唯一标识
+  eventLabel?: string;     // 事件显示名称（如"筛选期"）
+  forms?: string[];        // 该事件包含的表单列表
+  triggerType: TriggerType;
+  timestamp: string;
+  overallStatus: 'PASS' | 'FAIL' | 'WARNING' | 'UNCERTAIN';
+  summary: {
+    totalSkills: number;
+    passed: number;
+    failed: number;
+    warnings: number;
+    uncertain: number;
+    blockedByLevel1: boolean;
+  };
+  skillResults: SkillResult[];
+  allIssues: SkillIssue[];
+  criticalIssues: SkillIssue[];
+  warningIssues: SkillIssue[];
+  executionTimeMs: number;
+}
+
+/**
+ * SkillRunner 选项
+ * 
+ * V3.1: 支持事件级过滤
+ */
+export interface SkillRunnerOptions {
+  recordId?: string;
+  eventName?: string;      // V3.1: 指定事件
+  formName?: string;
+  skipSoftRules?: boolean;  // 跳过 LLM 检查（用于快速检查）
+}
+
+// ============================================================
+// SkillRunner 实现
+// ============================================================
+
+export class SkillRunner {
+  private projectId: string;
+  private redcapAdapter?: RedcapAdapter;
+
+  constructor(projectId: string) {
+    this.projectId = projectId;
+  }
+
+  /**
+   * 初始化 REDCap 适配器
+   */
+  private async initRedcapAdapter(): Promise<RedcapAdapter> {
+    if (this.redcapAdapter) {
+      return this.redcapAdapter;
+    }
+
+    const project = await prisma.iitProject.findUnique({
+      where: { id: this.projectId },
+      select: { redcapUrl: true, redcapApiToken: true },
+    });
+
+    if (!project) {
+      throw new Error(`项目不存在: ${this.projectId}`);
+    }
+
+    this.redcapAdapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+    return this.redcapAdapter;
+  }
+
+  /**
+   * 按触发类型执行 Skills
+   * 
+   * @param triggerType 触发类型
+   * @param options 执行选项
+   * @returns 执行结果
+   */
+  async runByTrigger(
+    triggerType: TriggerType,
+    options?: SkillRunnerOptions
+  ): Promise<SkillRunResult[]> {
+    const startTime = Date.now();
+
+    logger.info('[SkillRunner] Starting execution', {
+      projectId: this.projectId,
+      triggerType,
+      options,
+    });
+
+    // 1. 加载启用的 Skills
+    const skills = await this.loadSkills(triggerType, options?.formName);
+
+    if (skills.length === 0) {
+      logger.warn('[SkillRunner] No active skills found', {
+        projectId: this.projectId,
+        triggerType,
+      });
+      return [];
+    }
+
+    // 2. 按优先级排序（priority 越小越优先，blocking 级别最优先）
+    skills.sort((a, b) => {
+      if (a.level === 'blocking' && b.level !== 'blocking') return -1;
+      if (a.level !== 'blocking' && b.level === 'blocking') return 1;
+      return a.priority - b.priority;
+    });
+
+    // 3. 获取要处理的记录（V3.1: 事件级数据）
+    const records = await this.getRecordsToProcess(options);
+
+    // 4. 对每条记录+事件执行所有 Skills
+    const results: SkillRunResult[] = [];
+    for (const record of records) {
+      const result = await this.executeSkillsForRecord(
+        record.recordId,
+        record.eventName,
+        record.eventLabel,
+        record.forms,
+        record.data,
+        skills,
+        triggerType,
+        options
+      );
+      results.push(result);
+
+      // 保存质控日志
+      await this.saveQcLog(result);
+    }
+
+    const totalTime = Date.now() - startTime;
+    logger.info('[SkillRunner] Execution completed', {
+      projectId: this.projectId,
+      triggerType,
+      recordEventCount: records.length,
+      totalTimeMs: totalTime,
+    });
+
+    return results;
+  }
+
+  /**
+   * 加载 Skills
+   */
+  private async loadSkills(
+    triggerType: TriggerType,
+    formName?: string
+  ): Promise<Array<{
+    id: string;
+    skillType: string;
+    name: string;
+    ruleType: string;
+    level: string;
+    priority: number;
+    config: any;
+    requiredTags: string[];
+  }>> {
+    const where: any = {
+      projectId: this.projectId,
+      isActive: true,
+    };
+
+    // 根据触发类型过滤
+    if (triggerType === 'webhook') {
+      where.triggerType = 'webhook';
+    } else if (triggerType === 'cron') {
+      where.triggerType = { in: ['cron', 'webhook'] }; // Cron 也执行 webhook 规则
+    }
+    // manual 执行所有规则
+
+    const skills = await prisma.iitSkill.findMany({
+      where,
+      select: {
+        id: true,
+        skillType: true,
+        name: true,
+        ruleType: true,
+        level: true,
+        priority: true,
+        config: true,
+        requiredTags: true,
+      },
+    });
+
+    // 如果指定了 formName，过滤相关的 Skills
+    if (formName) {
+      return skills.filter(skill => {
+        const config = skill.config as any;
+        // 检查规则中是否有与该表单相关的规则
+        if (config?.rules) {
+          return config.rules.some((rule: any) => 
+            !rule.formName || rule.formName === formName
+          );
+        }
+        return true; // 没有 formName 限制的规则默认包含
+      });
+    }
+
+    return skills;
+  }
+
+  /**
+   * 获取要处理的记录（事件级别）
+   * 
+   * V3.1: 返回事件级数据，每个 record+event 作为独立单元
+   * 不再合并事件数据，确保每个访视独立质控
+   */
+  private async getRecordsToProcess(
+    options?: SkillRunnerOptions
+  ): Promise<Array<{ 
+    recordId: string; 
+    eventName: string;
+    eventLabel: string;
+    forms: string[];
+    data: Record<string, any>;
+  }>> {
+    const adapter = await this.initRedcapAdapter();
+
+    // V3.1: 使用 getAllRecordsByEvent 获取事件级数据
+    const eventRecords = await adapter.getAllRecordsByEvent({
+      recordId: options?.recordId,
+      eventName: options?.eventName,
+    });
+
+    return eventRecords.map(r => ({
+      recordId: r.recordId,
+      eventName: r.eventName,
+      eventLabel: r.eventLabel,
+      forms: r.forms,
+      data: r.data,
+    }));
+  }
+
+  /**
+   * 对单条记录+事件执行所有 Skills
+   * 
+   * V3.1: 支持事件级质控，根据规则配置过滤适用的规则
+   */
+  private async executeSkillsForRecord(
+    recordId: string,
+    eventName: string,
+    eventLabel: string,
+    forms: string[],
+    data: Record<string, any>,
+    skills: Array<{
+      id: string;
+      skillType: string;
+      name: string;
+      ruleType: string;
+      level: string;
+      priority: number;
+      config: any;
+      requiredTags: string[];
+    }>,
+    triggerType: TriggerType,
+    options?: SkillRunnerOptions
+  ): Promise<SkillRunResult> {
+    const startTime = Date.now();
+    const skillResults: SkillResult[] = [];
+    const allIssues: SkillIssue[] = [];
+    const criticalIssues: SkillIssue[] = [];
+    const warningIssues: SkillIssue[] = [];
+    let blockedByLevel1 = false;
+
+    // 漏斗式执行
+    for (const skill of skills) {
+      const ruleType = skill.ruleType as RuleType;
+
+      // 如果已被阻断且当前不是 blocking 级别，跳过 LLM 检查
+      if (blockedByLevel1 && ruleType === 'LLM_CHECK') {
+        logger.debug('[SkillRunner] Skipping LLM check due to blocking failure', {
+          skillId: skill.id,
+          recordId,
+          eventName,
+        });
+        continue;
+      }
+
+      // 如果选项要求跳过软规则
+      if (options?.skipSoftRules && ruleType === 'LLM_CHECK') {
+        continue;
+      }
+
+      // V3.1: 执行 Skill（传入事件和表单信息用于规则过滤）
+      const result = await this.executeSkill(skill, recordId, eventName, forms, data);
+      skillResults.push(result);
+
+      // 收集问题
+      for (const issue of result.issues) {
+        allIssues.push(issue);
+        if (issue.severity === 'critical') {
+          criticalIssues.push(issue);
+        } else if (issue.severity === 'warning') {
+          warningIssues.push(issue);
+        }
+      }
+
+      // 检查是否触发阻断
+      if (skill.level === 'blocking' && result.status === 'FAIL') {
+        blockedByLevel1 = true;
+        logger.info('[SkillRunner] Blocking check failed, skipping AI checks', {
+          skillId: skill.id,
+          recordId,
+          eventName,
+        });
+      }
+    }
+
+    // 计算整体状态
+    let overallStatus: 'PASS' | 'FAIL' | 'WARNING' | 'UNCERTAIN' = 'PASS';
+    if (criticalIssues.length > 0) {
+      overallStatus = 'FAIL';
+    } else if (skillResults.some(r => r.status === 'UNCERTAIN')) {
+      overallStatus = 'UNCERTAIN';
+    } else if (warningIssues.length > 0) {
+      overallStatus = 'WARNING';
+    }
+
+    const executionTimeMs = Date.now() - startTime;
+
+    return {
+      projectId: this.projectId,
+      recordId,
+      // V3.1: 包含事件信息
+      eventName,
+      eventLabel,
+      forms,
+      triggerType,
+      timestamp: new Date().toISOString(),
+      overallStatus,
+      summary: {
+        totalSkills: skillResults.length,
+        passed: skillResults.filter(r => r.status === 'PASS').length,
+        failed: skillResults.filter(r => r.status === 'FAIL').length,
+        warnings: skillResults.filter(r => r.status === 'WARNING').length,
+        uncertain: skillResults.filter(r => r.status === 'UNCERTAIN').length,
+        blockedByLevel1,
+      },
+      skillResults,
+      allIssues,
+      criticalIssues,
+      warningIssues,
+      executionTimeMs,
+    };
+  }
+
+  /**
+   * 执行单个 Skill
+   * 
+   * V3.1: 支持事件级质控，根据规则配置过滤适用的规则
+   */
+  private async executeSkill(
+    skill: {
+      id: string;
+      skillType: string;
+      name: string;
+      ruleType: string;
+      config: any;
+      requiredTags: string[];
+    },
+    recordId: string,
+    eventName: string,
+    forms: string[],
+    data: Record<string, any>
+  ): Promise<SkillResult> {
+    const startTime = Date.now();
+    const ruleType = skill.ruleType as RuleType;
+    const config = skill.config as any;
+    const issues: SkillIssue[] = [];
+    let status: 'PASS' | 'FAIL' | 'WARNING' | 'UNCERTAIN' = 'PASS';
+
+    try {
+      if (ruleType === 'HARD_RULE') {
+        // 使用 HardRuleEngine
+        const engine = await createHardRuleEngine(this.projectId);
+        
+        // 临时注入规则（如果 config 中有）
+        if (config?.rules) {
+          // V3.1: 过滤适用于当前事件/表单的规则
+          const allRules = config.rules as QCRule[];
+          const applicableRules = this.filterApplicableRules(allRules, eventName, forms);
+          
+          if (applicableRules.length > 0) {
+            const result = this.executeHardRulesDirectly(applicableRules, recordId, data);
+            issues.push(...result.issues);
+            status = result.status;
+          }
+        }
+
+      } else if (ruleType === 'LLM_CHECK') {
+        // 使用 SoftRuleEngine
+        const engine = createSoftRuleEngine(this.projectId, {
+          model: config?.model || 'deepseek-v3',
+        });
+
+        // V3.1: 过滤适用于当前事件/表单的检查
+        const rawChecks = config?.checks || [];
+        const applicableChecks = this.filterApplicableRules(rawChecks, eventName, forms);
+
+        const checks: SoftRuleCheck[] = applicableChecks.map((check: any) => ({
+          id: check.id,
+          name: check.name || check.desc,
+          description: check.desc,
+          promptTemplate: check.promptTemplate || check.prompt,
+          requiredTags: check.requiredTags || skill.requiredTags || [],
+          category: check.category || 'medical_logic',
+          severity: check.severity || 'warning',
+          applicableEvents: check.applicableEvents,
+          applicableForms: check.applicableForms,
+        }));
+
+        if (checks.length > 0) {
+          const result = await engine.execute(recordId, data, checks);
+          
+          for (const checkResult of result.results) {
+            if (checkResult.status !== 'PASS') {
+              issues.push({
+                ruleId: checkResult.checkId,
+                ruleName: checkResult.checkName,
+                message: checkResult.reason,
+                severity: checkResult.severity,
+                evidence: checkResult.evidence,
+                confidence: checkResult.confidence,
+              });
+            }
+          }
+
+          if (result.overallStatus === 'FAIL') {
+            status = 'FAIL';
+          } else if (result.overallStatus === 'UNCERTAIN') {
+            status = 'UNCERTAIN';
+          }
+        }
+
+      } else if (ruleType === 'HYBRID') {
+        // 混合模式：先执行硬规则，再执行软规则
+        // TODO: 实现混合逻辑
+        logger.warn('[SkillRunner] Hybrid rules not yet implemented', {
+          skillId: skill.id,
+        });
+      }
+    } catch (error: any) {
+      logger.error('[SkillRunner] Skill execution error', {
+        skillId: skill.id,
+        error: error.message,
+      });
+      status = 'UNCERTAIN';
+      issues.push({
+        ruleId: 'EXECUTION_ERROR',
+        ruleName: '执行错误',
+        message: `Skill 执行出错: ${error.message}`,
+        severity: 'warning',
+      });
+    }
+
+    const executionTimeMs = Date.now() - startTime;
+
+    return {
+      skillId: skill.id,
+      skillName: skill.name,
+      skillType: skill.skillType,
+      ruleType,
+      status,
+      issues,
+      executionTimeMs,
+    };
+  }
+
+  /**
+   * 直接执行硬规则（不通过 HardRuleEngine 初始化）
+   * 
+   * V2.1 优化：添加 expectedValue, llmMessage, evidence 字段
+   */
+  private executeHardRulesDirectly(
+    rules: QCRule[],
+    recordId: string,
+    data: Record<string, any>
+  ): { status: 'PASS' | 'FAIL' | 'WARNING'; issues: SkillIssue[] } {
+    const issues: SkillIssue[] = [];
+    let hasFail = false;
+    let hasWarning = false;
+
+    for (const rule of rules) {
+      try {
+        const passed = jsonLogic.apply(rule.logic, data);
+
+        if (!passed) {
+          const severity = rule.severity === 'error' ? 'critical' : 'warning';
+          const actualValue = this.getFieldValue(rule.field, data);
+          
+          // V2.1: 提取期望值
+          const expectedValue = this.extractExpectedValue(rule.logic);
+          
+          // V2.1: 构建自包含的 LLM 友好消息
+          const llmMessage = this.buildLlmMessage(rule, actualValue, expectedValue);
+          
+          issues.push({
+            ruleId: rule.id,
+            ruleName: rule.name,
+            field: rule.field,
+            message: rule.message,
+            llmMessage,  // V2.1: 自包含消息
+            severity,
+            actualValue,
+            expectedValue,  // V2.1: 期望值
+            evidence: {     // V2.1: 结构化证据
+              value: actualValue,
+              threshold: expectedValue,
+              unit: (rule.metadata as any)?.unit,
+            },
+          });
+
+          if (severity === 'critical') {
+            hasFail = true;
+          } else {
+            hasWarning = true;
+          }
+        }
+      } catch (error: any) {
+        logger.warn('[SkillRunner] Rule execution error', {
+          ruleId: rule.id,
+          error: error.message,
+        });
+      }
+    }
+
+    let status: 'PASS' | 'FAIL' | 'WARNING' = 'PASS';
+    if (hasFail) {
+      status = 'FAIL';
+    } else if (hasWarning) {
+      status = 'WARNING';
+    }
+
+    return { status, issues };
+  }
+
+  /**
+   * V2.1: 从 JSON Logic 中提取期望值
+   */
+  private extractExpectedValue(logic: Record<string, any>): string {
+    const operator = Object.keys(logic)[0];
+    const args = logic[operator];
+
+    switch (operator) {
+      case '>=':
+      case '<=':
+      case '>':
+      case '<':
+      case '==':
+      case '!=':
+        return String(args[1]);
+      case 'and':
+        // 对于 and 逻辑，尝试提取范围
+        if (Array.isArray(args)) {
+          const values = args.map((a: any) => this.extractExpectedValue(a)).filter(Boolean);
+          if (values.length === 2) {
+            return `${values[0]}-${values[1]}`;
+          }
+          return values.join(', ');
+        }
+        return '';
+      case '!!':
+        return '非空/必填';
+      default:
+        return '';
+    }
+  }
+
+  /**
+   * V2.1: 构建 LLM 友好的自包含消息
+   */
+  private buildLlmMessage(rule: QCRule, actualValue: any, expectedValue: string): string {
+    const displayValue = actualValue !== undefined && actualValue !== null && actualValue !== ''
+      ? `**${actualValue}**`
+      : '**空**';
+    
+    if (expectedValue) {
+      return `**${rule.name}**: 当前值 ${displayValue} (标准: ${expectedValue})`;
+    }
+    
+    return `**${rule.name}**: 当前值 ${displayValue}`;
+  }
+
+  /**
+   * 获取字段值
+   */
+  private getFieldValue(field: string | string[], data: Record<string, any>): any {
+    if (Array.isArray(field)) {
+      return field.map(f => data[f]);
+    }
+    return data[field];
+  }
+
+  /**
+   * V3.1: 过滤适用于当前事件/表单的规则
+   * 
+   * 规则配置可以包含：
+   * - applicableEvents: 适用的事件列表（空数组或不设置表示适用所有事件）
+   * - applicableForms: 适用的表单列表（空数组或不设置表示适用所有表单）
+   * 
+   * @param rules 所有规则
+   * @param eventName 当前事件名称
+   * @param forms 当前事件包含的表单列表
+   * @returns 适用于当前事件/表单的规则
+   */
+  private filterApplicableRules<T extends { applicableEvents?: string[]; applicableForms?: string[] }>(
+    rules: T[],
+    eventName: string,
+    forms: string[]
+  ): T[] {
+    return rules.filter(rule => {
+      // 检查事件是否适用
+      const eventMatch = !rule.applicableEvents || 
+                        rule.applicableEvents.length === 0 || 
+                        rule.applicableEvents.includes(eventName);
+
+      if (!eventMatch) {
+        return false;
+      }
+
+      // 检查表单是否适用
+      const formMatch = !rule.applicableForms || 
+                       rule.applicableForms.length === 0 || 
+                       rule.applicableForms.some(f => forms.includes(f));
+
+      return formMatch;
+    });
+  }
+
+  /**
+   * 保存质控日志
+   */
+  private async saveQcLog(result: SkillRunResult): Promise<void> {
+    try {
+      // 将结果保存到 iit_qc_logs 表
+      // V3.1: 包含事件信息
+      const issuesWithSummary = {
+        items: result.allIssues,
+        summary: result.summary,
+        // V3.1: 事件级质控元数据
+        eventLabel: result.eventLabel,
+        forms: result.forms,
+      };
+
+      await prisma.iitQcLog.create({
+        data: {
+          projectId: result.projectId,
+          recordId: result.recordId,
+          eventId: result.eventName,  // V3.1: 保存事件标识
+          qcType: 'event',  // V3.1: 事件级质控
+          formName: result.forms?.join(',') || null,  // 该事件包含的表单
+          status: result.overallStatus,
+          issues: JSON.parse(JSON.stringify(issuesWithSummary)),  // 转换为 JSON 兼容格式
+          ruleVersion: 'v3.1',  // V3.1: 事件级质控版本
+          rulesEvaluated: result.summary.totalSkills || 0,
+          rulesPassed: result.summary.passed || 0,
+          rulesFailed: result.summary.failed || 0,
+          rulesSkipped: 0,
+          triggeredBy: result.triggerType,
+          createdAt: new Date(result.timestamp),
+        },
+      });
+    } catch (error: any) {
+      logger.error('[SkillRunner] Failed to save QC log', {
+        recordId: result.recordId,
+        error: error.message,
+      });
+    }
+  }
+}
+
+// ============================================================
+// 工厂函数
+// ============================================================
+
+/**
+ * 创建 SkillRunner 实例
+ * 
+ * @param projectId 项目ID
+ * @returns SkillRunner 实例
+ */
+export function createSkillRunner(projectId: string): SkillRunner {
+  return new SkillRunner(projectId);
+}
diff --git a/backend/src/modules/iit-manager/engines/SoftRuleEngine.ts b/backend/src/modules/iit-manager/engines/SoftRuleEngine.ts
new file mode 100644
index 00000000..6bfc407c
--- /dev/null
+++ b/backend/src/modules/iit-manager/engines/SoftRuleEngine.ts
@@ -0,0 +1,487 @@
+/**
+ * SoftRuleEngine - 软规则质控引擎 (LLM 推理)
+ * 
+ * 功能：
+ * - 调用 LLM 进行复杂的医学逻辑判断
+ * - 支持入排标准、AE 事件检测、方案偏离等场景
+ * - 返回带证据链的结构化结果
+ * 
+ * 设计原则：
+ * - 智能推理：利用 LLM 处理模糊规则和复杂逻辑
+ * - 证据链：每个判断都附带推理过程和证据
+ * - 三态输出：PASS / FAIL / UNCERTAIN（需人工确认）
+ */
+
+import { PrismaClient } from '@prisma/client';
+import { LLMFactory } from '../../../common/llm/adapters/LLMFactory.js';
+import { ModelType } from '../../../common/llm/adapters/types.js';
+import { logger } from '../../../common/logging/index.js';
+import { buildClinicalSlice } from '../services/PromptBuilder.js';
+
+const prisma = new PrismaClient();
+
+// ============================================================
+// 类型定义
+// ============================================================
+
+/**
+ * 软规则检查项定义
+ */
+export interface SoftRuleCheck {
+  id: string;
+  name: string;
+  description?: string;
+  promptTemplate: string;           // Prompt 模板，支持 {{variable}} 占位符
+  requiredTags: string[];           // 需要加载的数据标签
+  category: 'inclusion' | 'exclusion' | 'ae_detection' | 'protocol_deviation' | 'medical_logic';
+  severity: 'critical' | 'warning';
+  
+  // V3.1: 事件级质控支持
+  /** 适用的事件列表，空数组或不设置表示适用所有事件 */
+  applicableEvents?: string[];
+  /** 适用的表单列表，空数组或不设置表示适用所有表单 */
+  applicableForms?: string[];
+}
+
+/**
+ * 软规则执行结果
+ */
+export interface SoftRuleResult {
+  checkId: string;
+  checkName: string;
+  status: 'PASS' | 'FAIL' | 'UNCERTAIN';
+  reason: string;                   // LLM 给出的判断理由
+  evidence: Record<string, any>;    // 支持判断的证据数据
+  confidence: number;               // 置信度 0-1
+  severity: 'critical' | 'warning';
+  category: string;
+  rawResponse?: string;             // 原始 LLM 响应（用于调试）
+}
+
+/**
+ * 软规则引擎配置
+ */
+export interface SoftRuleEngineConfig {
+  model?: ModelType;
+  maxConcurrency?: number;
+  timeoutMs?: number;
+}
+
+/**
+ * 软规则引擎执行结果
+ */
+export interface SoftRuleEngineResult {
+  recordId: string;
+  projectId: string;
+  timestamp: string;
+  overallStatus: 'PASS' | 'FAIL' | 'UNCERTAIN';
+  summary: {
+    totalChecks: number;
+    passed: number;
+    failed: number;
+    uncertain: number;
+  };
+  results: SoftRuleResult[];
+  failedChecks: SoftRuleResult[];
+  uncertainChecks: SoftRuleResult[];
+}
+
+// ============================================================
+// SoftRuleEngine 实现
+// ============================================================
+
+export class SoftRuleEngine {
+  private projectId: string;
+  private model: ModelType;
+  private timeoutMs: number;
+
+  constructor(projectId: string, config?: SoftRuleEngineConfig) {
+    this.projectId = projectId;
+    this.model = config?.model || 'deepseek-v3';
+    this.timeoutMs = config?.timeoutMs || 30000;
+  }
+
+  /**
+   * 执行软规则检查
+   * 
+   * @param recordId 记录ID
+   * @param data 记录数据
+   * @param checks 要执行的检查列表
+   * @returns 检查结果
+   */
+  async execute(
+    recordId: string,
+    data: Record<string, any>,
+    checks: SoftRuleCheck[]
+  ): Promise<SoftRuleEngineResult> {
+    const startTime = Date.now();
+    const results: SoftRuleResult[] = [];
+    const failedChecks: SoftRuleResult[] = [];
+    const uncertainChecks: SoftRuleResult[] = [];
+
+    logger.info('[SoftRuleEngine] Starting execution', {
+      projectId: this.projectId,
+      recordId,
+      checkCount: checks.length,
+      model: this.model,
+    });
+
+    // 逐个执行检查（可以改为并发，但需注意 Token 限制）
+    for (const check of checks) {
+      try {
+        const result = await this.executeCheck(recordId, data, check);
+        results.push(result);
+
+        if (result.status === 'FAIL') {
+          failedChecks.push(result);
+        } else if (result.status === 'UNCERTAIN') {
+          uncertainChecks.push(result);
+        }
+      } catch (error: any) {
+        logger.error('[SoftRuleEngine] Check execution failed', {
+          checkId: check.id,
+          error: error.message,
+        });
+
+        // 发生错误时标记为 UNCERTAIN
+        const errorResult: SoftRuleResult = {
+          checkId: check.id,
+          checkName: check.name,
+          status: 'UNCERTAIN',
+          reason: `执行出错: ${error.message}`,
+          evidence: {},
+          confidence: 0,
+          severity: check.severity,
+          category: check.category,
+        };
+        results.push(errorResult);
+        uncertainChecks.push(errorResult);
+      }
+    }
+
+    // 计算整体状态
+    let overallStatus: 'PASS' | 'FAIL' | 'UNCERTAIN' = 'PASS';
+    if (failedChecks.length > 0) {
+      overallStatus = 'FAIL';
+    } else if (uncertainChecks.length > 0) {
+      overallStatus = 'UNCERTAIN';
+    }
+
+    const duration = Date.now() - startTime;
+
+    logger.info('[SoftRuleEngine] Execution completed', {
+      recordId,
+      overallStatus,
+      totalChecks: checks.length,
+      failed: failedChecks.length,
+      uncertain: uncertainChecks.length,
+      duration: `${duration}ms`,
+    });
+
+    return {
+      recordId,
+      projectId: this.projectId,
+      timestamp: new Date().toISOString(),
+      overallStatus,
+      summary: {
+        totalChecks: checks.length,
+        passed: results.filter(r => r.status === 'PASS').length,
+        failed: failedChecks.length,
+        uncertain: uncertainChecks.length,
+      },
+      results,
+      failedChecks,
+      uncertainChecks,
+    };
+  }
+
+  /**
+   * 执行单个检查
+   */
+  private async executeCheck(
+    recordId: string,
+    data: Record<string, any>,
+    check: SoftRuleCheck
+  ): Promise<SoftRuleResult> {
+    const startTime = Date.now();
+
+    // 1. 构建 Prompt
+    const prompt = this.buildCheckPrompt(recordId, data, check);
+
+    // 2. 调用 LLM
+    const llmAdapter = LLMFactory.getAdapter(this.model);
+    const response = await llmAdapter.chat([
+      {
+        role: 'system',
+        content: this.getSystemPrompt(),
+      },
+      {
+        role: 'user',
+        content: prompt,
+      },
+    ]);
+
+    const rawResponse = response.content;
+
+    // 3. 解析响应
+    const parsed = this.parseResponse(rawResponse, check);
+
+    const duration = Date.now() - startTime;
+
+    logger.debug('[SoftRuleEngine] Check executed', {
+      checkId: check.id,
+      status: parsed.status,
+      confidence: parsed.confidence,
+      duration: `${duration}ms`,
+    });
+
+    return {
+      checkId: check.id,
+      checkName: check.name,
+      status: parsed.status,
+      reason: parsed.reason,
+      evidence: parsed.evidence,
+      confidence: parsed.confidence,
+      severity: check.severity,
+      category: check.category,
+      rawResponse,
+    };
+  }
+
+  /**
+   * 构建检查 Prompt
+   */
+  private buildCheckPrompt(
+    recordId: string,
+    data: Record<string, any>,
+    check: SoftRuleCheck
+  ): string {
+    // 使用 PromptBuilder 生成临床数据切片
+    const clinicalSlice = buildClinicalSlice({
+      task: check.name,
+      criteria: [check.description || check.name],
+      patientData: data,
+      tags: check.requiredTags,
+      instruction: '请根据以下数据进行判断。',
+    });
+
+    // 替换 Prompt 模板中的变量
+    let userPrompt = check.promptTemplate;
+    
+    // 替换 {{variable}} 格式的占位符
+    userPrompt = userPrompt.replace(/\{\{(\w+)\}\}/g, (_, key) => {
+      return data[key] !== undefined ? String(data[key]) : `[${key}未提供]`;
+    });
+
+    // 替换 {{#tag}} 格式的数据标签
+    userPrompt = userPrompt.replace(/\{\{#(\w+)\}\}/g, (_, tag) => {
+      // 根据标签筛选相关字段
+      return JSON.stringify(data, null, 2);
+    });
+
+    return `${clinicalSlice}\n\n---\n\n## 检查任务\n\n${userPrompt}`;
+  }
+
+  /**
+   * 获取系统 Prompt
+   */
+  private getSystemPrompt(): string {
+    return `你是一个专业的临床研究数据监查员 (CRA)，负责核查受试者数据的质量和合规性。
+
+## 你的职责
+1. 仔细分析提供的临床数据
+2. 根据检查任务进行判断
+3. 给出清晰的判断结果和理由
+
+## 输出格式要求
+请严格按照以下 JSON 格式输出：
+
+\`\`\`json
+{
+  "status": "PASS" | "FAIL" | "UNCERTAIN",
+  "reason": "判断理由的详细说明",
+  "evidence": {
+    "key_field_1": "相关数据值",
+    "key_field_2": "相关数据值"
+  },
+  "confidence": 0.95
+}
+\`\`\`
+
+## 状态说明
+- **PASS**: 检查通过，数据符合要求
+- **FAIL**: 检查失败，发现问题
+- **UNCERTAIN**: 数据不足或存在歧义，需要人工确认
+
+## 置信度说明
+- 0.9-1.0: 非常确定
+- 0.7-0.9: 比较确定
+- 0.5-0.7: 有一定把握
+- <0.5: 不太确定，建议人工复核
+
+请只输出 JSON，不要有其他内容。`;
+  }
+
+  /**
+   * 解析 LLM 响应
+   */
+  private parseResponse(
+    rawResponse: string,
+    check: SoftRuleCheck
+  ): {
+    status: 'PASS' | 'FAIL' | 'UNCERTAIN';
+    reason: string;
+    evidence: Record<string, any>;
+    confidence: number;
+  } {
+    try {
+      // 尝试提取 JSON
+      const jsonMatch = rawResponse.match(/```json\s*([\s\S]*?)\s*```/);
+      const jsonStr = jsonMatch ? jsonMatch[1] : rawResponse;
+
+      const parsed = JSON.parse(jsonStr.trim());
+
+      // 验证状态值
+      const validStatuses = ['PASS', 'FAIL', 'UNCERTAIN'];
+      const status = validStatuses.includes(parsed.status?.toUpperCase())
+        ? parsed.status.toUpperCase()
+        : 'UNCERTAIN';
+
+      return {
+        status: status as 'PASS' | 'FAIL' | 'UNCERTAIN',
+        reason: parsed.reason || '未提供理由',
+        evidence: parsed.evidence || {},
+        confidence: typeof parsed.confidence === 'number' 
+          ? Math.min(1, Math.max(0, parsed.confidence)) 
+          : 0.5,
+      };
+    } catch (error) {
+      logger.warn('[SoftRuleEngine] Failed to parse LLM response', {
+        checkId: check.id,
+        rawResponse: rawResponse.substring(0, 500),
+      });
+
+      // 解析失败时尝试简单匹配
+      const lowerResponse = rawResponse.toLowerCase();
+      if (lowerResponse.includes('pass') || lowerResponse.includes('通过')) {
+        return {
+          status: 'PASS',
+          reason: rawResponse,
+          evidence: {},
+          confidence: 0.6,
+        };
+      } else if (lowerResponse.includes('fail') || lowerResponse.includes('失败') || lowerResponse.includes('不符合')) {
+        return {
+          status: 'FAIL',
+          reason: rawResponse,
+          evidence: {},
+          confidence: 0.6,
+        };
+      }
+
+      return {
+        status: 'UNCERTAIN',
+        reason: `无法解析响应: ${rawResponse.substring(0, 200)}`,
+        evidence: {},
+        confidence: 0.3,
+      };
+    }
+  }
+
+  /**
+   * 批量执行检查
+   * 
+   * @param records 记录列表
+   * @param checks 检查列表
+   * @returns 所有记录的检查结果
+   */
+  async executeBatch(
+    records: Array<{ recordId: string; data: Record<string, any> }>,
+    checks: SoftRuleCheck[]
+  ): Promise<SoftRuleEngineResult[]> {
+    const results: SoftRuleEngineResult[] = [];
+
+    for (const record of records) {
+      const result = await this.execute(record.recordId, record.data, checks);
+      results.push(result);
+    }
+
+    return results;
+  }
+}
+
+// ============================================================
+// 工厂函数
+// ============================================================
+
+/**
+ * 创建 SoftRuleEngine 实例
+ * 
+ * @param projectId 项目ID
+ * @param config 可选配置
+ * @returns SoftRuleEngine 实例
+ */
+export function createSoftRuleEngine(
+  projectId: string,
+  config?: SoftRuleEngineConfig
+): SoftRuleEngine {
+  return new SoftRuleEngine(projectId, config);
+}
+
+// ============================================================
+// 预置检查模板
+// ============================================================
+
+/**
+ * 入排标准检查模板
+ */
+export const INCLUSION_EXCLUSION_CHECKS: SoftRuleCheck[] = [
+  {
+    id: 'IE-001',
+    name: '年龄入组标准',
+    description: '检查受试者年龄是否符合入组标准',
+    promptTemplate: '请根据受试者数据，判断其年龄是否在研究方案规定的入组范围内。如果年龄字段缺失，请标记为 UNCERTAIN。',
+    requiredTags: ['#demographics'],
+    category: 'inclusion',
+    severity: 'critical',
+  },
+  {
+    id: 'IE-002',
+    name: '确诊时间入组标准',
+    description: '检查受试者确诊时间是否符合入组标准（通常要求确诊在一定时间内）',
+    promptTemplate: '请根据受试者的确诊日期和入组日期，判断确诊时间是否符合研究方案要求。',
+    requiredTags: ['#demographics', '#medical_history'],
+    category: 'inclusion',
+    severity: 'critical',
+  },
+];
+
+/**
+ * AE 事件检测模板
+ */
+export const AE_DETECTION_CHECKS: SoftRuleCheck[] = [
+  {
+    id: 'AE-001',
+    name: 'Lab 异常与 AE 一致性',
+    description: '检查实验室检查异常值是否已在 AE 表中报告',
+    promptTemplate: '请对比实验室检查数据和不良事件记录，判断是否存在未报告的实验室异常（Grade 3 及以上）。',
+    requiredTags: ['#lab', '#ae'],
+    category: 'ae_detection',
+    severity: 'critical',
+  },
+];
+
+/**
+ * 方案偏离检测模板
+ */
+export const PROTOCOL_DEVIATION_CHECKS: SoftRuleCheck[] = [
+  {
+    id: 'PD-001',
+    name: '访视超窗检测',
+    description: '检查访视是否在方案规定的时间窗口内',
+    promptTemplate: '请根据访视日期数据，判断各访视之间的时间间隔是否符合方案规定的访视窗口。',
+    requiredTags: ['#visits'],
+    category: 'protocol_deviation',
+    severity: 'warning',
+  },
+];
diff --git a/backend/src/modules/iit-manager/engines/index.ts b/backend/src/modules/iit-manager/engines/index.ts
index 17852a26..49e2854f 100644
--- a/backend/src/modules/iit-manager/engines/index.ts
+++ b/backend/src/modules/iit-manager/engines/index.ts
@@ -3,4 +3,6 @@
  */
 
 export * from './HardRuleEngine.js';
+export * from './SoftRuleEngine.js';
 export * from './SopEngine.js';
+export * from './SkillRunner.js';
diff --git a/backend/src/modules/iit-manager/services/ChatService.ts b/backend/src/modules/iit-manager/services/ChatService.ts
index 0126125e..9014e14a 100644
--- a/backend/src/modules/iit-manager/services/ChatService.ts
+++ b/backend/src/modules/iit-manager/services/ChatService.ts
@@ -21,6 +21,15 @@ import { PrismaClient } from '@prisma/client';
 import { RedcapAdapter } from '../adapters/RedcapAdapter.js';
 import { getVectorSearchService } from '../../../common/rag/index.js';
 import { HardRuleEngine, createHardRuleEngine, QCResult } from '../engines/HardRuleEngine.js';
+import { 
+  PromptBuilder, 
+  buildClinicalSlice, 
+  buildQcSummary, 
+  buildEnrollmentSummary,
+  buildRecordDetail,
+  buildQcIssuesList,
+  wrapAsSystemMessage 
+} from './PromptBuilder.js';
 
 const prisma = new PrismaClient();
 
@@ -74,6 +83,9 @@ export class ChatService {
       } else if (intent === 'query_qc_status') {
         // ⭐ 质控状态查询（优先查询质控表）
         toolResult = await this.queryQcStatus();
+      } else if (intent === 'query_qc_report') {
+        // ⭐ V3.0 质控报告查询（报告驱动模式）
+        toolResult = await this.getQcReport();
       }
 
       // 4. 如果需要查询文档（自研RAG知识库），执行检索
@@ -146,7 +158,7 @@ export class ChatService {
    * 简单意图识别（基于关键词）
    */
   private detectIntent(message: string): {
-    intent: 'query_record' | 'count_records' | 'project_info' | 'query_protocol' | 'qc_record' | 'qc_all' | 'query_enrollment' | 'query_qc_status' | 'general_chat';
+    intent: 'query_record' | 'count_records' | 'project_info' | 'query_protocol' | 'qc_record' | 'qc_all' | 'query_enrollment' | 'query_qc_status' | 'query_qc_report' | 'general_chat';
     params?: any;
   } {
     const lowerMessage = message.toLowerCase();
@@ -159,10 +171,26 @@ export class ChatService {
       return { intent: 'query_enrollment' };
     }
 
+    // ⭐ V3.1 识别质控报告查询（优先级最高 - 报告驱动模式）
+    // 增强：支持更多自然语言表达方式
+    if (/(质控|QC).*(报告|概述|分析|总结)/.test(message) ||
+        /报告.*?(质控|分析|问题)/.test(message) ||
+        /(给我|生成|查看|提供).*?报告/.test(message) ||
+        /(严重|警告|违规).*?(问题|几项|几条|多少|有哪些|列表|详情)/.test(message) ||
+        /(表单|CRF).*?(统计|通过率)/.test(message) ||
+        // V3.1: 增强匹配 - 问题数量类查询
+        /有几(条|项|个).*?(质控|问题|违规)/.test(message) ||
+        /(质控|问题|违规).*?有几(条|项|个)/.test(message) ||
+        /质控问题/.test(message) ||
+        /严重违规/.test(message) ||
+        /record.*?问题/.test(lowerMessage)) {
+      return { intent: 'query_qc_report' };
+    }
+
     // ⭐ 识别质控状态查询（从质控表快速返回）
     // "质控情况"、"质控状态"、"有多少问题"等
     if (/(质控|QC).*?(情况|状态|汇总|统计|概况|结果)/.test(message) ||
-        /(问题|错误|警告).*?(多少|几个|统计)/.test(message) ||
+        /(问题|错误|警告).*?(多少|几个|几条|几项|统计)/.test(message) ||
         /哪些.*?(问题|不合格|失败)/.test(message)) {
       return { intent: 'query_qc_status' };
     }
@@ -234,6 +262,8 @@ export class ChatService {
 
   /**
    * 构建包含数据的LLM消息
+   * 
+   * ⭐ V2.9.1 优化：使用 PromptBuilder 的 XML 临床切片格式
    */
   private buildMessagesWithData(
     userMessage: string,
@@ -251,19 +281,12 @@ export class ChatService {
       content: this.getSystemPromptWithData(userId)
     });
 
-    // 2. 如果有REDCap查询结果，注入到System消息
+    // 2. 如果有数据查询结果，使用 PromptBuilder 格式化注入
     if (toolResult) {
+      const formattedContent = this.formatToolResultWithPromptBuilder(toolResult, intent);
       messages.push({
         role: 'system',
-        content: `【REDCap数据查询结果 - 这是真实数据，必须使用】
-${JSON.stringify(toolResult, null, 2)}
-
-⚠️ 重要提示：
-1. 上述数据是从REDCap系统实时查询的真实数据
-2. 你必须且只能使用上述数据中的字段值回答用户
-3. 如果某个字段为空或不存在，请如实告知"该字段未填写"
-4. 绝对禁止编造任何不在上述数据中的信息
-5. 如果数据中包含error字段，说明查询失败，请友好地告知用户`
+        content: formattedContent
       });
     } else {
       // 没有查询到数据时的提示
@@ -316,6 +339,8 @@ ${ragKnowledge}
 
   /**
    * 新的System Prompt（强调基于真实数据）
+   * 
+   * V2.1 优化：添加"定位→提取→引用→诚实"思维链约束
    */
   private getSystemPromptWithData(userId: string): string {
     return `你是IIT Manager智能助手，负责帮助PI管理临床研究项目。
@@ -333,12 +358,30 @@ ${ragKnowledge}
 
 编造临床研究信息可能导致严重医疗事故！
 
+【V2.1 思维链约束 - 回答质控报告问题时必须遵循】
+当回答质控报告相关问题时，请严格按照以下 4 步进行：
+
+1. **定位 (Locate)**：在 <qc_context> 中找到相关章节
+   - 统计类问题 → 查看 <summary>
+   - 问题详情类 → 查看 <critical_issues> 或 <warning_issues>
+   
+2. **提取 (Extract)**：精确提取数值和信息
+   - 不要推测、不要计算（除非数据明确给出）
+   
+3. **引用 (Cite)**：回答时引用来源
+   - 例："根据报告，记录 ID 1 存在年龄超标问题 (当前 45岁，标准 25-35岁)"
+   
+4. **诚实 (Grounding)**：如果报告中没有相关信息
+   - 明确说"报告中未包含该信息"
+   - 不要编造、不要推测
+
 【你的能力】
 - 回答研究进展问题（仅基于REDCap实时数据）
 - 查询患者记录详情（仅基于REDCap实时数据）
 - 统计入组人数（仅基于REDCap实时数据）
 - 解答研究方案问题（仅基于知识库检索到的文档）
 - 数据质控（仅基于系统执行的规则检查结果）
+- 质控报告分析（仅基于预生成的 QC 报告）
 
 【质控结果解读】
 - PASS：记录完全符合所有规则
@@ -364,6 +407,7 @@ ${ragKnowledge}
 2. 诚实告知不足：没有数据就说"暂无相关信息"
 3. 简洁专业：控制在200字以内
 4. 引导行动：建议登录REDCap或联系管理员获取更多信息
+5. 引用来源：回答质控问题时，引用报告中的具体数据
 
 【当前用户】
 企业微信UserID: ${userId}
@@ -877,6 +921,53 @@ ${ragKnowledge}
     }
   }
 
+  /**
+   * 获取质控报告（V3.0 报告驱动模式）
+   * 
+   * ⭐ 特点：
+   * - 预生成的 XML 报告，LLM 直接阅读理解
+   * - 包含完整的问题汇总、表单统计、严重问题列表
+   * - 比实时质控更快、更全面
+   */
+  private async getQcReport(): Promise<any> {
+    try {
+      const project = await prisma.iitProject.findFirst({
+        where: { status: 'active' },
+        select: { id: true, name: true }
+      });
+
+      if (!project) {
+        return { error: '未找到活跃项目配置' };
+      }
+
+      // 动态导入 QcReportService（避免循环依赖）
+      const { QcReportService } = await import('./QcReportService.js');
+      
+      // 获取报告
+      const report = await QcReportService.getReport(project.id);
+
+      logger.info('[ChatService] 获取质控报告成功', {
+        projectId: project.id,
+        criticalIssues: report.criticalIssues.length,
+        warningIssues: report.warningIssues.length,
+        passRate: report.summary.passRate,
+      });
+
+      return {
+        projectName: project.name,
+        source: 'qc_report',
+        type: 'qc_report',  // 标识类型，用于格式化
+        report: report,
+        // LLM 友好的 XML 报告
+        llmReport: report.llmFriendlyXml,
+      };
+
+    } catch (error: any) {
+      logger.error('[ChatService] 获取质控报告失败', { error: error.message });
+      return { error: `获取报告失败: ${error.message}` };
+    }
+  }
+
   /**
    * 查询知识库（研究方案文档）- 使用自研 RAG 引擎
    */
@@ -949,6 +1040,385 @@ ${ragKnowledge}
     }
   }
 
+  // ============================================================
+  // PromptBuilder 格式化方法
+  // ============================================================
+
+  /**
+   * 根据意图使用 PromptBuilder 格式化工具结果
+   * 
+   * ⭐ V2.9.1 新增：使用 XML 临床切片格式，减少 LLM 幻觉
+   */
+  private formatToolResultWithPromptBuilder(toolResult: any, intent: string): string {
+    // 如果有错误，直接返回错误信息
+    if (toolResult.error) {
+      return `【查询失败】\n${toolResult.error}\n\n请告知用户查询失败，并建议稍后重试或联系管理员。`;
+    }
+
+    try {
+      switch (intent) {
+        case 'query_record':
+          return this.formatRecordDetailXml(toolResult);
+        
+        case 'qc_record':
+          return this.formatQcRecordXml(toolResult);
+        
+        case 'qc_all':
+          return this.formatQcAllXml(toolResult);
+        
+        case 'query_enrollment':
+          return this.formatEnrollmentXml(toolResult);
+        
+        case 'query_qc_status':
+          return this.formatQcStatusXml(toolResult);
+        
+        case 'query_qc_report':
+          return this.formatQcReportXml(toolResult);
+        
+        case 'count_records':
+          return this.formatCountRecordsXml(toolResult);
+        
+        case 'project_info':
+          return this.formatProjectInfoXml(toolResult);
+        
+        default:
+          // 默认使用 JSON 格式（兼容旧逻辑）
+          return wrapAsSystemMessage(
+            `<data>\n${JSON.stringify(toolResult, null, 2)}\n</data>`,
+            'REDCap'
+          );
+      }
+    } catch (error: any) {
+      logger.error('[ChatService] PromptBuilder 格式化失败，回退到 JSON', { 
+        intent, 
+        error: error.message 
+      });
+      return `【REDCap数据查询结果】\n${JSON.stringify(toolResult, null, 2)}`;
+    }
+  }
+
+  /**
+   * 格式化记录详情为 XML
+   */
+  private formatRecordDetailXml(result: any): string {
+    const xmlContent = buildRecordDetail({
+      projectName: result.projectName || '未知项目',
+      recordId: result.recordId,
+      data: result,
+      qcResult: result.qcResult
+    });
+
+    return wrapAsSystemMessage(xmlContent, 'REDCap');
+  }
+
+  /**
+   * 格式化单条质控结果为 XML
+   */
+  private formatQcRecordXml(result: any): string {
+    const { projectName, recordId, source, qcResult } = result;
+    
+    // 构建临床切片
+    const xmlContent = buildClinicalSlice({
+      task: `核查记录 ${recordId} 的质控结果`,
+      patientData: {},  // 数据已在 qcResult 中
+      instruction: '请向用户解释质控结果，重点说明发现的问题及其严重程度。'
+    });
+
+    // 添加质控结果
+    const qcXml = `
+<qc_result record_id="${recordId}" status="${qcResult?.overallStatus || 'UNKNOWN'}" source="${source}">
+  <summary>
+    <total_rules>${qcResult?.summary?.totalRules || 0}</total_rules>
+    <passed>${qcResult?.summary?.passed || 0}</passed>
+    <failed>${qcResult?.summary?.failed || 0}</failed>
+  </summary>
+  ${qcResult?.errors?.length > 0 ? `
+  <errors>
+    ${qcResult.errors.map((e: any) => 
+      `<error field="${e.field || 'unknown'}" rule="${e.rule || ''}">${e.message}</error>`
+    ).join('\n    ')}
+  </errors>` : ''}
+  ${qcResult?.warnings?.length > 0 ? `
+  <warnings>
+    ${qcResult.warnings.map((w: any) => 
+      `<warning field="${w.field || 'unknown'}" rule="${w.rule || ''}">${w.message}</warning>`
+    ).join('\n    ')}
+  </warnings>` : ''}
+</qc_result>`;
+
+    // 生成自然语言摘要
+    const summary = buildQcSummary({
+      projectName: projectName || '当前项目',
+      totalRecords: 1,
+      passedRecords: qcResult?.overallStatus === 'PASS' ? 1 : 0,
+      failedRecords: qcResult?.overallStatus === 'FAIL' ? 1 : 0,
+      warningRecords: qcResult?.overallStatus === 'WARNING' ? 1 : 0,
+      topIssues: qcResult?.errors?.slice(0, 3).map((e: any) => ({
+        issue: e.message,
+        count: 1
+      })) || []
+    });
+
+    return wrapAsSystemMessage(
+      `${qcXml}\n\n<natural_summary>\n${summary}\n</natural_summary>`,
+      source === 'cached' ? 'QC_TABLE' : 'REDCap'
+    );
+  }
+
+  /**
+   * 格式化批量质控结果为 XML
+   */
+  private formatQcAllXml(result: any): string {
+    const { projectName, totalRecords, summary, problemRecords } = result;
+    
+    const xmlContent = buildQcIssuesList({
+      projectName: projectName || '当前项目',
+      totalRecords: totalRecords || 0,
+      passedRecords: summary?.pass || 0,
+      failedRecords: summary?.fail || 0,
+      problemRecords: (problemRecords || []).map((r: any) => ({
+        recordId: r.recordId,
+        status: r.status,
+        issues: (r.topIssues || []).map((i: any) => ({
+          message: i.message
+        }))
+      }))
+    });
+
+    // 添加自然语言摘要
+    const naturalSummary = buildQcSummary({
+      projectName: projectName || '当前项目',
+      totalRecords: totalRecords || 0,
+      passedRecords: summary?.pass || 0,
+      failedRecords: summary?.fail || 0,
+      warningRecords: summary?.warning || 0
+    });
+
+    return wrapAsSystemMessage(
+      `${xmlContent}\n\n<natural_summary>\n${naturalSummary}\n</natural_summary>`,
+      'REDCap'
+    );
+  }
+
+  /**
+   * 格式化录入进度为 XML
+   */
+  private formatEnrollmentXml(result: any): string {
+    if (result.message) {
+      return `【录入进度查询】\n${result.message}`;
+    }
+
+    const naturalSummary = buildEnrollmentSummary({
+      projectName: result.projectName || '当前项目',
+      totalRecords: result.totalRecords || 0,
+      avgCompletionRate: parseFloat(result.avgCompletionRate) || 0,
+      recentEnrollments: result.recentEnrollments || 0,
+      byQcStatus: result.byQcStatus || { pass: 0, fail: 0, warning: 0, pending: 0 }
+    });
+
+    // 构建最近记录列表
+    const recentRecordsXml = result.recentRecords?.length > 0
+      ? `<recent_records>
+${result.recentRecords.map((r: any) => 
+  `  <record id="${r.recordId}" completion="${r.completionRate}%" qc_status="${r.qcStatus}" />`
+).join('\n')}
+</recent_records>`
+      : '';
+
+    return wrapAsSystemMessage(
+      `<enrollment_summary project="${result.projectName}">\n${naturalSummary}\n</enrollment_summary>\n${recentRecordsXml}`,
+      'SUMMARY_TABLE'
+    );
+  }
+
+  /**
+   * 格式化质控状态为 XML
+   */
+  private formatQcStatusXml(result: any): string {
+    if (result.message) {
+      return `【质控状态查询】\n${result.message}`;
+    }
+
+    const { projectName, stats, recentChecks, problemRecords } = result;
+    
+    let xmlContent = `<qc_status project="${projectName}">`;
+    
+    if (stats) {
+      xmlContent += `
+  <stats>
+    <total_records>${stats.totalRecords}</total_records>
+    <passed>${stats.passedRecords}</passed>
+    <failed>${stats.failedRecords}</failed>
+    <warning>${stats.warningRecords}</warning>
+    <pass_rate>${stats.passRate}</pass_rate>
+    <last_updated>${stats.lastUpdated}</last_updated>
+  </stats>`;
+    }
+
+    if (problemRecords?.length > 0) {
+      xmlContent += `
+  <problem_records count="${problemRecords.length}">
+${problemRecords.map((r: any) => 
+  `    <record id="${r.recordId}" status="${r.status}" issues="${r.issueCount}" checked_at="${r.checkedAt}" />`
+).join('\n')}
+  </problem_records>`;
+    }
+
+    xmlContent += `\n</qc_status>`;
+
+    // 生成自然语言摘要
+    const naturalSummary = stats ? buildQcSummary({
+      projectName: projectName || '当前项目',
+      totalRecords: stats.totalRecords,
+      passedRecords: stats.passedRecords,
+      failedRecords: stats.failedRecords,
+      warningRecords: stats.warningRecords
+    }) : '暂无质控统计数据';
+
+    return wrapAsSystemMessage(
+      `${xmlContent}\n\n<natural_summary>\n${naturalSummary}\n</natural_summary>`,
+      'QC_TABLE'
+    );
+  }
+
+  /**
+   * 格式化记录统计为 XML
+   */
+  private formatCountRecordsXml(result: any): string {
+    const { projectName, totalRecords, recordIds } = result;
+    
+    const xmlContent = `<record_count project="${projectName}">
+  <total>${totalRecords}</total>
+  <record_ids>${(recordIds || []).slice(0, 10).join(', ')}${totalRecords > 10 ? '...' : ''}</record_ids>
+</record_count>`;
+
+    const naturalSummary = `项目【${projectName}】当前共有 ${totalRecords} 条记录。`;
+
+    return wrapAsSystemMessage(
+      `${xmlContent}\n\n<natural_summary>${naturalSummary}</natural_summary>`,
+      'REDCap'
+    );
+  }
+
+  /**
+   * 格式化项目信息为 XML
+   */
+  private formatProjectInfoXml(result: any): string {
+    const { projectId, projectName, description, redcapProjectId, lastSyncAt, createdAt } = result;
+    
+    const xmlContent = `<project_info id="${projectId}">
+  <name>${projectName}</name>
+  <description>${description || '暂无描述'}</description>
+  <redcap_project_id>${redcapProjectId || '未配置'}</redcap_project_id>
+  <last_sync>${lastSyncAt}</last_sync>
+  <created_at>${createdAt}</created_at>
+</project_info>`;
+
+    const naturalSummary = `当前项目：【${projectName}】
+- 项目描述：${description || '暂无'}
+- REDCap 项目 ID：${redcapProjectId || '未配置'}
+- 最后同步时间：${lastSyncAt}
+- 创建时间：${createdAt}`;
+
+    return wrapAsSystemMessage(
+      `${xmlContent}\n\n<natural_summary>\n${naturalSummary}\n</natural_summary>`,
+      'REDCap'
+    );
+  }
+
+  /**
+   * 格式化质控报告为 XML（V3.0 报告驱动模式）
+   * 
+   * V2.1 优化：
+   * - 直接使用 QcReportService 预生成的 LLM 友好 XML 报告
+   * - 添加思维链约束提示
+   * - 信息自包含，减少 LLM 幻觉
+   */
+  private formatQcReportXml(result: any): string {
+    const { projectName, llmReport, report } = result;
+    
+    // V2.1: 使用预生成的 LLM 友好报告
+    if (llmReport) {
+      const intro = `【质控报告 - 请严格基于此报告回答】
+项目: ${projectName}
+生成时间: ${report?.generatedAt || new Date().toISOString()}
+
+---
+请按照"定位→提取→引用→诚实"思维链回答用户问题：
+1. 定位：在报告中找到相关章节
+2. 提取：精确提取数值（不要推测）
+3. 引用：回答时引用具体数据和受试者ID
+4. 诚实：报告中没有的信息，明确说"报告中未包含"
+---`;
+
+      return wrapAsSystemMessage(
+        `${intro}\n\n${llmReport}`,
+        'QC_REPORT'
+      );
+    }
+
+    // 回退：如果没有预生成报告，从 report 对象构建
+    if (report) {
+      const summary = report.summary || {};
+      const topIssues = report.topIssues || [];
+      const groupedIssues = report.groupedIssues || [];
+
+      // V2.1: 构建简化的 LLM 友好格式
+      let fallbackXml = `<qc_context project="${projectName}">
+  
+  <summary>
+    - 状态: ${groupedIssues.length}/${summary.totalRecords || 0} 记录存在严重违规
+    - 通过率: ${summary.passRate || 0}%
+    - 严重问题: ${summary.criticalIssues || 0} | 警告: ${summary.warningIssues || 0}`;
+
+      if (topIssues.length > 0) {
+        fallbackXml += `
+    - Top ${Math.min(3, topIssues.length)} 问题:
+${topIssues.slice(0, 3).map((t: any, i: number) => `      ${i + 1}. ${t.ruleName} (${t.count}人)`).join('\n')}`;
+      }
+
+      fallbackXml += `
+  </summary>
+
+`;
+
+      // 添加分组的严重问题
+      if (groupedIssues.length > 0) {
+        fallbackXml += `  <critical_issues record_count="${groupedIssues.length}">\n`;
+        for (const group of groupedIssues.slice(0, 10)) {
+          fallbackXml += `    <record id="${group.recordId}">\n`;
+          fallbackXml += `      严重违规 (${group.issueCount}项):\n`;
+          for (let i = 0; i < Math.min(group.issues.length, 5); i++) {
+            const issue = group.issues[i];
+            const actualDisplay = issue.actualValue !== undefined ? `**${issue.actualValue}**` : '**空**';
+            const expectedDisplay = issue.expectedValue ? ` (标准: ${issue.expectedValue})` : '';
+            fallbackXml += `      ${i + 1}. **${issue.ruleName}**: 当前值 ${actualDisplay}${expectedDisplay}\n`;
+          }
+          fallbackXml += `    </record>\n`;
+        }
+        fallbackXml += `  </critical_issues>\n\n`;
+      }
+
+      fallbackXml += `</qc_context>`;
+
+      const intro = `【质控报告 - 请严格基于此报告回答】
+项目: ${projectName}
+
+请按照"定位→提取→引用→诚实"思维链回答用户问题。`;
+
+      return wrapAsSystemMessage(
+        `${intro}\n\n${fallbackXml}`,
+        'QC_REPORT'
+      );
+    }
+
+    // 最终回退：无数据
+    return wrapAsSystemMessage(
+      `<qc_report_error>无法获取质控报告数据</qc_report_error>`,
+      'QC_REPORT'
+    );
+  }
+
   /**
    * 清除用户会话（用于重置对话）
    */
diff --git a/backend/src/modules/iit-manager/services/PromptBuilder.ts b/backend/src/modules/iit-manager/services/PromptBuilder.ts
new file mode 100644
index 00000000..dbb81d0c
--- /dev/null
+++ b/backend/src/modules/iit-manager/services/PromptBuilder.ts
@@ -0,0 +1,447 @@
+/**
+ * PromptBuilder - LLM 提示词构建器
+ * 
+ * 功能：
+ * - 构建 XML 临床切片格式（对 LLM 更友好，减少幻觉）
+ * - 生成自然语言摘要
+ * - 支持按语义标签过滤数据
+ * 
+ * 设计原则：
+ * - XML 格式比 JSON 更适合 LLM 理解
+ * - 语义化标签便于上下文切片
+ * - 明确的任务指令减少幻觉
+ * 
+ * @see docs/03-业务模块/IIT Manager Agent/04-开发计划/07-质控系统UI与LLM格式优化计划.md
+ */
+
+import { logger } from '../../../common/logging/index.js';
+
+// ============================================================
+// 类型定义
+// ============================================================
+
+export interface ClinicalSliceParams {
+  /** 任务描述 */
+  task: string;
+  /** 研究方案中的标准（入排标准等） */
+  criteria?: string[];
+  /** 患者数据 */
+  patientData: Record<string, any>;
+  /** 语义标签（用于过滤数据） */
+  tags?: string[];
+  /** 额外的指令 */
+  instruction?: string;
+  /** 字段元数据（用于增强展示） */
+  fieldMetadata?: Record<string, FieldMetadata>;
+}
+
+export interface FieldMetadata {
+  /** 字段标签（中文名） */
+  label?: string;
+  /** 字段类型 */
+  type?: 'text' | 'number' | 'date' | 'radio' | 'checkbox' | 'dropdown';
+  /** 正常范围（数值型） */
+  normalRange?: { min?: number; max?: number };
+  /** 选项（选择型） */
+  options?: Array<{ value: string; label: string }>;
+  /** 语义标签 */
+  tags?: string[];
+}
+
+export interface QcSummaryParams {
+  projectName: string;
+  totalRecords: number;
+  passedRecords: number;
+  failedRecords: number;
+  warningRecords?: number;
+  topIssues?: Array<{ issue: string; count: number }>;
+}
+
+export interface EnrollmentSummaryParams {
+  projectName: string;
+  totalRecords: number;
+  avgCompletionRate: number;
+  recentEnrollments: number;
+  byQcStatus: {
+    pass: number;
+    fail: number;
+    warning: number;
+    pending: number;
+  };
+}
+
+export interface RecordDetailParams {
+  projectName: string;
+  recordId: string;
+  data: Record<string, any>;
+  fieldMetadata?: Record<string, FieldMetadata>;
+  qcResult?: {
+    status: string;
+    errors?: Array<{ field: string; message: string; actualValue?: any }>;
+    warnings?: Array<{ field: string; message: string; actualValue?: any }>;
+  };
+}
+
+// ============================================================
+// PromptBuilder 实现
+// ============================================================
+
+export class PromptBuilder {
+  /**
+   * 构建 XML 临床切片格式
+   * 
+   * 输出格式示例：
+   * ```xml
+   * <task>核查该患者是否符合研究入排标准</task>
+   * 
+   * <protocol_criteria>
+   *     1. 年龄 16-35 岁。
+   *     2. 月经周期规律（28±7天）。
+   * </protocol_criteria>
+   * 
+   * <patient_slice tag="#demographics, #screening">
+   *     - 出生日期：2003-01-07（当前年龄 22 岁）✅
+   *     - 月经周期：45 天 ⚠️ 超出范围
+   * </patient_slice>
+   * 
+   * <instruction>
+   * 请一步步推理，对比患者数据与标准。如发现异常，说明具体哪条标准被违反。
+   * </instruction>
+   * ```
+   */
+  static buildClinicalSlice(params: ClinicalSliceParams): string {
+    const { 
+      task, 
+      criteria = [], 
+      patientData, 
+      tags = [], 
+      instruction,
+      fieldMetadata = {}
+    } = params;
+
+    const parts: string[] = [];
+
+    // 1. 任务描述
+    parts.push(`<task>${task}</task>`);
+    parts.push('');
+
+    // 2. 研究方案标准（如果有）
+    if (criteria.length > 0) {
+      parts.push('<protocol_criteria>');
+      criteria.forEach((c, i) => {
+        parts.push(`    ${i + 1}. ${c}`);
+      });
+      parts.push('</protocol_criteria>');
+      parts.push('');
+    }
+
+    // 3. 患者数据切片
+    const tagAttr = tags.length > 0 ? ` tag="${tags.join(', ')}"` : '';
+    parts.push(`<patient_slice${tagAttr}>`);
+
+    // 格式化患者数据
+    const formattedData = PromptBuilder.formatPatientData(patientData, fieldMetadata);
+    formattedData.forEach(line => {
+      parts.push(`    ${line}`);
+    });
+
+    parts.push('</patient_slice>');
+    parts.push('');
+
+    // 4. 指令（如果有）
+    if (instruction) {
+      parts.push('<instruction>');
+      parts.push(instruction);
+      parts.push('</instruction>');
+    }
+
+    return parts.join('\n').trim();
+  }
+
+  /**
+   * 格式化患者数据为可读格式
+   */
+  private static formatPatientData(
+    data: Record<string, any>,
+    metadata: Record<string, FieldMetadata>
+  ): string[] {
+    const lines: string[] = [];
+
+    for (const [key, value] of Object.entries(data)) {
+      // 跳过系统字段
+      if (key.startsWith('redcap_') || key === 'record_id') continue;
+
+      const meta = metadata[key];
+      const label = meta?.label || key;
+      const formattedValue = PromptBuilder.formatFieldValue(value, meta);
+      const statusIcon = PromptBuilder.getStatusIcon(value, meta);
+
+      lines.push(`- ${label}: ${formattedValue}${statusIcon ? ' ' + statusIcon : ''}`);
+    }
+
+    return lines;
+  }
+
+  /**
+   * 格式化字段值
+   */
+  private static formatFieldValue(value: any, meta?: FieldMetadata): string {
+    if (value === null || value === undefined || value === '') {
+      return '未填写';
+    }
+
+    // 日期类型
+    if (meta?.type === 'date' && typeof value === 'string') {
+      return value;
+    }
+
+    // 选择类型
+    if (meta?.options && meta.options.length > 0) {
+      const option = meta.options.find(o => o.value === String(value));
+      return option ? option.label : String(value);
+    }
+
+    // 数值类型 - 添加范围信息
+    if (meta?.type === 'number' && meta.normalRange) {
+      const { min, max } = meta.normalRange;
+      const numValue = Number(value);
+      if (!isNaN(numValue)) {
+        const rangeInfo: string[] = [];
+        if (min !== undefined) rangeInfo.push(`≥${min}`);
+        if (max !== undefined) rangeInfo.push(`≤${max}`);
+        if (rangeInfo.length > 0) {
+          return `${value} (正常范围: ${rangeInfo.join(', ')})`;
+        }
+      }
+    }
+
+    return String(value);
+  }
+
+  /**
+   * 获取状态图标
+   */
+  private static getStatusIcon(value: any, meta?: FieldMetadata): string {
+    if (value === null || value === undefined || value === '') {
+      return '⚠️';  // 缺失
+    }
+
+    // 检查数值是否在范围内
+    if (meta?.normalRange) {
+      const numValue = Number(value);
+      if (!isNaN(numValue)) {
+        const { min, max } = meta.normalRange;
+        if ((min !== undefined && numValue < min) || (max !== undefined && numValue > max)) {
+          return '❌ 超出范围';
+        }
+        return '✅';
+      }
+    }
+
+    return '';
+  }
+
+  /**
+   * 构建质控结果摘要（自然语言）
+   * 
+   * 输出示例：
+   * "项目 test0207 共有 13 条记录，质控通过率 0%。主要问题包括：知情同意未签署（13条）、入排标准不符（8条）。"
+   */
+  static buildQcSummary(params: QcSummaryParams): string {
+    const { 
+      projectName, 
+      totalRecords, 
+      passedRecords, 
+      failedRecords,
+      warningRecords = 0,
+      topIssues = [] 
+    } = params;
+
+    const passRate = totalRecords > 0 
+      ? ((passedRecords / totalRecords) * 100).toFixed(1) 
+      : '0';
+
+    let summary = `项目【${projectName}】共有 ${totalRecords} 条记录，质控通过率 ${passRate}%。`;
+
+    if (failedRecords > 0) {
+      summary += `\n\n【质控统计】\n`;
+      summary += `- 通过: ${passedRecords} 条\n`;
+      summary += `- 失败: ${failedRecords} 条\n`;
+      if (warningRecords > 0) {
+        summary += `- 警告: ${warningRecords} 条\n`;
+      }
+    }
+
+    if (topIssues.length > 0) {
+      const issueText = topIssues
+        .slice(0, 3)
+        .map(i => `${i.issue}（${i.count}条）`)
+        .join('、');
+      summary += `\n【主要问题】${issueText}`;
+    }
+
+    return summary;
+  }
+
+  /**
+   * 构建录入进度摘要（自然语言）
+   */
+  static buildEnrollmentSummary(params: EnrollmentSummaryParams): string {
+    const { 
+      projectName, 
+      totalRecords, 
+      avgCompletionRate,
+      recentEnrollments,
+      byQcStatus 
+    } = params;
+
+    let summary = `项目【${projectName}】录入概况：\n\n`;
+    summary += `【基本统计】\n`;
+    summary += `- 总记录数: ${totalRecords} 条\n`;
+    summary += `- 平均完成率: ${avgCompletionRate.toFixed(1)}%\n`;
+    summary += `- 近一周新增: ${recentEnrollments} 条\n`;
+
+    summary += `\n【质控分布】\n`;
+    summary += `- 通过: ${byQcStatus.pass} 条\n`;
+    summary += `- 失败: ${byQcStatus.fail} 条\n`;
+    summary += `- 警告: ${byQcStatus.warning} 条\n`;
+    summary += `- 待质控: ${byQcStatus.pending} 条`;
+
+    return summary;
+  }
+
+  /**
+   * 构建记录详情的 XML 格式
+   */
+  static buildRecordDetail(params: RecordDetailParams): string {
+    const { projectName, recordId, data, fieldMetadata = {}, qcResult } = params;
+
+    const parts: string[] = [];
+
+    // 1. 记录头部信息
+    parts.push(`<record id="${recordId}" project="${projectName}">`);
+    parts.push('');
+
+    // 2. 数据内容
+    parts.push('  <data>');
+    for (const [key, value] of Object.entries(data)) {
+      if (key.startsWith('redcap_') || key === 'record_id') continue;
+      
+      const meta = fieldMetadata[key];
+      const label = meta?.label || key;
+      const formattedValue = value ?? '未填写';
+      parts.push(`    <field name="${key}" label="${label}">${formattedValue}</field>`);
+    }
+    parts.push('  </data>');
+
+    // 3. 质控结果（如果有）
+    if (qcResult) {
+      parts.push('');
+      parts.push(`  <qc_result status="${qcResult.status}">`);
+      
+      if (qcResult.errors && qcResult.errors.length > 0) {
+        parts.push('    <errors>');
+        qcResult.errors.forEach(e => {
+          parts.push(`      <error field="${e.field}">${e.message}</error>`);
+        });
+        parts.push('    </errors>');
+      }
+
+      if (qcResult.warnings && qcResult.warnings.length > 0) {
+        parts.push('    <warnings>');
+        qcResult.warnings.forEach(w => {
+          parts.push(`      <warning field="${w.field}">${w.message}</warning>`);
+        });
+        parts.push('    </warnings>');
+      }
+
+      parts.push('  </qc_result>');
+    }
+
+    parts.push('');
+    parts.push('</record>');
+
+    return parts.join('\n');
+  }
+
+  /**
+   * 构建质控问题列表的 XML 格式
+   * 用于批量质控结果展示
+   */
+  static buildQcIssuesList(params: {
+    projectName: string;
+    totalRecords: number;
+    passedRecords: number;
+    failedRecords: number;
+    problemRecords: Array<{
+      recordId: string;
+      status: string;
+      issues: Array<{ field?: string; message: string }>;
+    }>;
+  }): string {
+    const { projectName, totalRecords, passedRecords, failedRecords, problemRecords } = params;
+
+    const parts: string[] = [];
+
+    // 1. 项目概览
+    parts.push(`<qc_overview project="${projectName}">`);
+    parts.push(`  <stats>`);
+    parts.push(`    <total>${totalRecords}</total>`);
+    parts.push(`    <passed>${passedRecords}</passed>`);
+    parts.push(`    <failed>${failedRecords}</failed>`);
+    parts.push(`    <pass_rate>${((passedRecords / totalRecords) * 100).toFixed(1)}%</pass_rate>`);
+    parts.push(`  </stats>`);
+    parts.push('');
+
+    // 2. 问题记录列表
+    if (problemRecords.length > 0) {
+      parts.push('  <problem_records>');
+      problemRecords.forEach(record => {
+        parts.push(`    <record id="${record.recordId}" status="${record.status}">`);
+        record.issues.slice(0, 3).forEach(issue => {
+          const fieldAttr = issue.field ? ` field="${issue.field}"` : '';
+          parts.push(`      <issue${fieldAttr}>${issue.message}</issue>`);
+        });
+        parts.push('    </record>');
+      });
+      parts.push('  </problem_records>');
+    }
+
+    parts.push('</qc_overview>');
+
+    return parts.join('\n');
+  }
+
+  /**
+   * 包装 XML 内容为 LLM 系统消息
+   */
+  static wrapAsSystemMessage(xmlContent: string, dataSource: 'REDCap' | 'QC_TABLE' | 'SUMMARY_TABLE' | 'QC_REPORT'): string {
+    const sourceLabel = {
+      'REDCap': 'REDCap 系统实时数据',
+      'QC_TABLE': '质控日志表缓存数据',
+      'SUMMARY_TABLE': '录入汇总表缓存数据',
+      'QC_REPORT': '质控报告（预生成）'
+    }[dataSource];
+
+    return `【${sourceLabel} - 以下是真实数据，必须使用】
+
+${xmlContent}
+
+⚠️ 重要提示：
+1. 上述数据是从系统查询的真实数据
+2. 你必须且只能使用上述数据中的内容回答用户
+3. 如果某个字段为空或标记为"未填写"，请如实告知
+4. 绝对禁止编造任何不在上述数据中的信息
+5. 如果数据中包含 <error> 标签，说明存在质控问题，需要重点说明`;
+  }
+}
+
+// 导出单例便捷方法
+export const buildClinicalSlice = PromptBuilder.buildClinicalSlice;
+export const buildQcSummary = PromptBuilder.buildQcSummary;
+export const buildEnrollmentSummary = PromptBuilder.buildEnrollmentSummary;
+export const buildRecordDetail = PromptBuilder.buildRecordDetail;
+export const buildQcIssuesList = PromptBuilder.buildQcIssuesList;
+export const wrapAsSystemMessage = PromptBuilder.wrapAsSystemMessage;
+
+export default PromptBuilder;
diff --git a/backend/src/modules/iit-manager/services/QcReportService.ts b/backend/src/modules/iit-manager/services/QcReportService.ts
new file mode 100644
index 00000000..9c9bd76b
--- /dev/null
+++ b/backend/src/modules/iit-manager/services/QcReportService.ts
@@ -0,0 +1,979 @@
+/**
+ * QcReportService - 质控报告生成服务
+ * 
+ * 功能：
+ * - 聚合质控统计数据
+ * - 生成 LLM 友好的 XML 报告
+ * - 缓存报告以提高查询效率
+ * 
+ * 设计原则：
+ * - 报告驱动：预计算报告，LLM 只需阅读
+ * - 双模输出：人类可读 + LLM 友好格式
+ * - 智能缓存：报告有效期内直接返回缓存
+ */
+
+import { PrismaClient } from '@prisma/client';
+import { logger } from '../../../common/logging/index.js';
+
+const prisma = new PrismaClient();
+
+// ============================================================
+// 类型定义
+// ============================================================
+
+/**
+ * 报告摘要
+ */
+export interface ReportSummary {
+  totalRecords: number;
+  completedRecords: number;
+  criticalIssues: number;
+  warningIssues: number;
+  pendingQueries: number;
+  passRate: number;
+  lastQcTime: string | null;
+}
+
+/**
+ * 问题项
+ */
+export interface ReportIssue {
+  recordId: string;
+  ruleId: string;
+  ruleName: string;
+  severity: 'critical' | 'warning' | 'info';
+  message: string;
+  field?: string;
+  actualValue?: any;
+  expectedValue?: any;
+  evidence?: Record<string, any>;
+  detectedAt: string;
+}
+
+/**
+ * 表单统计
+ */
+export interface FormStats {
+  formName: string;
+  formLabel: string;
+  totalChecks: number;
+  passed: number;
+  failed: number;
+  passRate: number;
+}
+
+/**
+ * 质控报告
+ */
+export interface QcReport {
+  projectId: string;
+  reportType: 'daily' | 'weekly' | 'on_demand';
+  generatedAt: string;
+  expiresAt: string | null;
+  summary: ReportSummary;
+  criticalIssues: ReportIssue[];
+  warningIssues: ReportIssue[];
+  formStats: FormStats[];
+  topIssues: TopIssue[];            // V2.1: Top 问题统计
+  groupedIssues: GroupedIssues[];   // V2.1: 按受试者分组
+  llmFriendlyXml: string;           // V2.1: LLM 友好格式
+  legacyXml?: string;               // V2.1: 兼容旧格式
+}
+
+/**
+ * 报告选项
+ */
+export interface ReportOptions {
+  forceRefresh?: boolean;  // 强制刷新，忽略缓存
+  reportType?: 'daily' | 'weekly' | 'on_demand';
+  expirationHours?: number;  // 报告有效期（小时）
+  format?: 'xml' | 'llm-friendly';  // V2.1: 输出格式
+}
+
+/**
+ * V2.1: 按受试者分组的问题
+ */
+export interface GroupedIssues {
+  recordId: string;
+  issueCount: number;
+  issues: ReportIssue[];
+}
+
+/**
+ * V2.1: Top 问题统计
+ */
+export interface TopIssue {
+  ruleName: string;
+  ruleId: string;
+  count: number;
+  affectedRecords: string[];
+}
+
+// ============================================================
+// QcReportService 实现
+// ============================================================
+
+class QcReportServiceClass {
+  /**
+   * 获取项目质控报告
+   * 
+   * @param projectId 项目 ID
+   * @param options 报告选项
+   * @returns 质控报告
+   */
+  async getReport(projectId: string, options?: ReportOptions): Promise<QcReport> {
+    const reportType = options?.reportType || 'on_demand';
+    const expirationHours = options?.expirationHours || 24;
+
+    // 1. 检查缓存
+    if (!options?.forceRefresh) {
+      const cached = await this.getCachedReport(projectId, reportType);
+      if (cached) {
+        logger.debug('[QcReportService] Returning cached report', {
+          projectId,
+          reportType,
+          generatedAt: cached.generatedAt,
+        });
+        return cached;
+      }
+    }
+
+    // 2. 生成新报告
+    logger.info('[QcReportService] Generating new report', {
+      projectId,
+      reportType,
+    });
+
+    const report = await this.generateReport(projectId, reportType, expirationHours);
+
+    // 3. 缓存报告
+    await this.cacheReport(report);
+
+    return report;
+  }
+
+  /**
+   * 获取缓存的报告
+   */
+  private async getCachedReport(
+    projectId: string,
+    reportType: string
+  ): Promise<QcReport | null> {
+    try {
+      const cached = await prisma.iitQcReport.findFirst({
+        where: {
+          projectId,
+          reportType,
+          OR: [
+            { expiresAt: null },
+            { expiresAt: { gt: new Date() } },
+          ],
+        },
+        orderBy: { generatedAt: 'desc' },
+      });
+
+      if (!cached) {
+        return null;
+      }
+
+      const issuesData = cached.issues as any || {};
+
+      return {
+        projectId: cached.projectId,
+        reportType: cached.reportType as 'daily' | 'weekly' | 'on_demand',
+        generatedAt: cached.generatedAt.toISOString(),
+        expiresAt: cached.expiresAt?.toISOString() || null,
+        summary: cached.summary as unknown as ReportSummary,
+        criticalIssues: (issuesData.critical || []) as ReportIssue[],
+        warningIssues: (issuesData.warning || []) as ReportIssue[],
+        formStats: (issuesData.formStats || []) as FormStats[],
+        topIssues: (issuesData.topIssues || []) as TopIssue[],
+        groupedIssues: (issuesData.groupedIssues || []) as GroupedIssues[],
+        llmFriendlyXml: cached.llmReport,
+        legacyXml: issuesData.legacyXml,
+      };
+    } catch (error: any) {
+      logger.warn('[QcReportService] Failed to get cached report', {
+        projectId,
+        error: error.message,
+      });
+      return null;
+    }
+  }
+
+  /**
+   * 生成新报告
+   * 
+   * V2.1 优化：支持双格式输出
+   */
+  private async generateReport(
+    projectId: string,
+    reportType: 'daily' | 'weekly' | 'on_demand',
+    expirationHours: number
+  ): Promise<QcReport> {
+    const startTime = Date.now();
+
+    // 1. 获取项目信息
+    const project = await prisma.iitProject.findUnique({
+      where: { id: projectId },
+      select: {
+        id: true,
+        name: true,
+        fieldMappings: true,
+      },
+    });
+
+    if (!project) {
+      throw new Error(`项目不存在: ${projectId}`);
+    }
+
+    // 2. 聚合质控统计
+    const summary = await this.aggregateStats(projectId);
+
+    // 3. 获取问题列表
+    const { criticalIssues, warningIssues } = await this.getIssues(projectId);
+
+    // 4. 获取表单统计
+    const formStats = await this.getFormStats(projectId);
+
+    // 5. V2.1: 计算 Top Issues 和分组
+    const allIssues = [...criticalIssues, ...warningIssues];
+    const topIssues = this.calculateTopIssues(allIssues);
+    const groupedIssues = this.groupIssuesByRecord(criticalIssues);
+
+    // 6. V2.1: 生成双格式 XML 报告
+    const llmFriendlyXml = this.buildLlmXmlReport(
+      projectId,
+      project.name || projectId,
+      summary,
+      criticalIssues,
+      warningIssues,
+      formStats
+    );
+
+    const legacyXml = this.buildLegacyXmlReport(
+      projectId,
+      project.name || projectId,
+      summary,
+      criticalIssues,
+      warningIssues,
+      formStats
+    );
+
+    const generatedAt = new Date();
+    const expiresAt = new Date(generatedAt.getTime() + expirationHours * 60 * 60 * 1000);
+
+    const duration = Date.now() - startTime;
+    logger.info('[QcReportService] Report generated', {
+      projectId,
+      reportType,
+      duration: `${duration}ms`,
+      criticalCount: criticalIssues.length,
+      warningCount: warningIssues.length,
+      topIssuesCount: topIssues.length,
+      groupedRecordCount: groupedIssues.length,
+    });
+
+    return {
+      projectId,
+      reportType,
+      generatedAt: generatedAt.toISOString(),
+      expiresAt: expiresAt.toISOString(),
+      summary,
+      criticalIssues,
+      warningIssues,
+      formStats,
+      topIssues,
+      groupedIssues,
+      llmFriendlyXml,
+      legacyXml,
+    };
+  }
+
+  /**
+   * 聚合质控统计
+   * 
+   * V3.1: 修复记录数统计和 issues 格式兼容性
+   */
+  private async aggregateStats(projectId: string): Promise<ReportSummary> {
+    // 获取记录汇总（用于 completedRecords 统计）
+    const recordSummaries = await prisma.iitRecordSummary.findMany({
+      where: { projectId },
+    });
+
+    const completedRecords = recordSummaries.filter(r => 
+      r.completionRate && (r.completionRate as number) >= 100
+    ).length;
+
+    // V3.1: 获取每个 record+event 的最新质控日志（避免重复）
+    const latestQcLogs = await prisma.$queryRaw<Array<{
+      record_id: string;
+      event_id: string | null;
+      form_name: string | null;
+      status: string;
+      issues: any;
+      created_at: Date;
+    }>>`
+      SELECT DISTINCT ON (record_id, COALESCE(event_id, ''))
+        record_id, event_id, form_name, status, issues, created_at
+      FROM iit_schema.qc_logs
+      WHERE project_id = ${projectId}
+      ORDER BY record_id, COALESCE(event_id, ''), created_at DESC
+    `;
+
+    // V3.1: 从质控日志获取独立 record_id 数量
+    const uniqueRecordIds = new Set(latestQcLogs.map(log => log.record_id));
+    const totalRecords = uniqueRecordIds.size;
+
+    // V3.1: 统计问题数量（按 recordId + ruleId 去重）
+    const seenCritical = new Set<string>();
+    const seenWarning = new Set<string>();
+    let pendingQueries = 0;
+
+    for (const log of latestQcLogs) {
+      // V3.1: 兼容两种 issues 格式
+      const rawIssues = log.issues as any;
+      let issues: any[] = [];
+      
+      if (Array.isArray(rawIssues)) {
+        issues = rawIssues;
+      } else if (rawIssues && Array.isArray(rawIssues.items)) {
+        issues = rawIssues.items;
+      }
+
+      for (const issue of issues) {
+        const ruleId = issue.ruleId || issue.ruleName || 'unknown';
+        const key = `${log.record_id}:${ruleId}`;
+        const severity = issue.severity || issue.level;
+        
+        if (severity === 'critical' || severity === 'RED' || severity === 'error') {
+          seenCritical.add(key);
+        } else if (severity === 'warning' || severity === 'YELLOW') {
+          seenWarning.add(key);
+        }
+      }
+
+      if (log.status === 'UNCERTAIN' || log.status === 'PENDING') {
+        pendingQueries++;
+      }
+    }
+
+    const criticalIssues = seenCritical.size;
+    const warningIssues = seenWarning.size;
+
+    // 计算通过率
+    const passedRecords = latestQcLogs.filter(log => 
+      log.status === 'PASS' || log.status === 'GREEN'
+    ).length;
+    const passRate = totalRecords > 0 
+      ? Math.round((passedRecords / totalRecords) * 100 * 10) / 10 
+      : 0;
+
+    // 获取最后质控时间
+    const lastQcLog = await prisma.iitQcLog.findFirst({
+      where: { projectId },
+      orderBy: { createdAt: 'desc' },
+      select: { createdAt: true },
+    });
+
+    return {
+      totalRecords,
+      completedRecords,
+      criticalIssues,
+      warningIssues,
+      pendingQueries,
+      passRate,
+      lastQcTime: lastQcLog?.createdAt?.toISOString() || null,
+    };
+  }
+
+  /**
+   * 获取问题列表
+   */
+  private async getIssues(projectId: string): Promise<{
+    criticalIssues: ReportIssue[];
+    warningIssues: ReportIssue[];
+  }> {
+    // V3.1: 获取每个 record+event 的最新质控日志
+    const latestQcLogs = await prisma.$queryRaw<Array<{
+      record_id: string;
+      event_id: string | null;
+      form_name: string | null;
+      status: string;
+      issues: any;
+      created_at: Date;
+    }>>`
+      SELECT DISTINCT ON (record_id, COALESCE(event_id, ''))
+        record_id, event_id, form_name, status, issues, created_at
+      FROM iit_schema.qc_logs
+      WHERE project_id = ${projectId}
+      ORDER BY record_id, COALESCE(event_id, ''), created_at DESC
+    `;
+
+    const criticalIssues: ReportIssue[] = [];
+    const warningIssues: ReportIssue[] = [];
+
+    for (const log of latestQcLogs) {
+      // V2.1: 兼容两种 issues 格式
+      // 新格式: { items: [...], summary: {...} }
+      // 旧格式: [...]
+      const rawIssues = log.issues as any;
+      let issues: any[] = [];
+      
+      if (Array.isArray(rawIssues)) {
+        // 旧格式：直接是数组
+        issues = rawIssues;
+      } else if (rawIssues && Array.isArray(rawIssues.items)) {
+        // 新格式：对象包含 items 数组
+        issues = rawIssues.items;
+      } else {
+        continue;
+      }
+
+      for (const issue of issues) {
+        // V2.1: 构建自包含的 LLM 友好消息
+        const llmMessage = this.buildSelfContainedMessage(issue);
+        
+        const reportIssue: ReportIssue = {
+          recordId: log.record_id,
+          ruleId: issue.ruleId || issue.ruleName || 'unknown',
+          ruleName: issue.ruleName || issue.message || 'Unknown Rule',
+          severity: this.normalizeSeverity(issue.severity || issue.level),
+          message: llmMessage,  // V2.1: 使用自包含消息
+          field: issue.field,
+          actualValue: issue.actualValue,
+          expectedValue: issue.expectedValue || this.extractExpectedFromMessage(issue.message),
+          evidence: issue.evidence,
+          detectedAt: log.created_at.toISOString(),
+        };
+
+        if (reportIssue.severity === 'critical') {
+          criticalIssues.push(reportIssue);
+        } else if (reportIssue.severity === 'warning') {
+          warningIssues.push(reportIssue);
+        }
+      }
+    }
+
+    // V3.1: 按 recordId + ruleId 去重，保留最新的问题（避免多事件重复）
+    const deduplicateCritical = this.deduplicateIssues(criticalIssues);
+    const deduplicateWarning = this.deduplicateIssues(warningIssues);
+
+    return { criticalIssues: deduplicateCritical, warningIssues: deduplicateWarning };
+  }
+
+  /**
+   * V3.1: 按 recordId + ruleId 去重问题
+   * 
+   * 同一记录的同一规则只保留一条（最新的，因为数据已按时间倒序排列）
+   */
+  private deduplicateIssues(issues: ReportIssue[]): ReportIssue[] {
+    const seen = new Map<string, ReportIssue>();
+    
+    for (const issue of issues) {
+      const key = `${issue.recordId}:${issue.ruleId}`;
+      if (!seen.has(key)) {
+        seen.set(key, issue);
+      }
+      // 如果已存在，跳过（因为按时间倒序，第一个就是最新的）
+    }
+    
+    return Array.from(seen.values());
+  }
+
+  /**
+   * V2.1: 构建自包含的 LLM 友好消息
+   */
+  private buildSelfContainedMessage(issue: any): string {
+    const ruleName = issue.ruleName || issue.message || 'Unknown';
+    const actualValue = issue.actualValue;
+    const expectedValue = issue.expectedValue || this.extractExpectedFromMessage(issue.message);
+    
+    // 如果已经有自包含格式，直接返回
+    if (issue.llmMessage) {
+      return issue.llmMessage;
+    }
+
+    // 构建自包含格式
+    const actualDisplay = actualValue !== undefined && actualValue !== null && actualValue !== ''
+      ? `**${actualValue}**`
+      : '**空**';
+    
+    if (expectedValue) {
+      return `**${ruleName}**: 当前值 ${actualDisplay} (标准: ${expectedValue})`;
+    }
+    
+    return `**${ruleName}**: 当前值 ${actualDisplay}`;
+  }
+
+  /**
+   * V2.1: 从原始消息中提取期望值
+   * 例如："年龄不在 25-35 岁范围内" -> "25-35 岁"
+   */
+  private extractExpectedFromMessage(message: string): string | undefined {
+    if (!message) return undefined;
+    
+    // 尝试提取数字范围：如 "25-35"
+    const rangeMatch = message.match(/(\d+)\s*[-~至到]\s*(\d+)/);
+    if (rangeMatch) {
+      return `${rangeMatch[1]}-${rangeMatch[2]}`;
+    }
+    
+    // 尝试提取日期范围
+    const dateRangeMatch = message.match(/(\d{4}-\d{2}-\d{2})\s*至\s*(\d{4}-\d{2}-\d{2})/);
+    if (dateRangeMatch) {
+      return `${dateRangeMatch[1]} 至 ${dateRangeMatch[2]}`;
+    }
+    
+    return undefined;
+  }
+
+  /**
+   * 标准化严重程度
+   */
+  private normalizeSeverity(severity: string): 'critical' | 'warning' | 'info' {
+    const lower = (severity || '').toLowerCase();
+    if (lower === 'critical' || lower === 'red' || lower === 'error') {
+      return 'critical';
+    } else if (lower === 'warning' || lower === 'yellow') {
+      return 'warning';
+    }
+    return 'info';
+  }
+
+  /**
+   * 获取表单统计
+   */
+  private async getFormStats(projectId: string): Promise<FormStats[]> {
+    // 获取表单标签映射
+    const project = await prisma.iitProject.findUnique({
+      where: { id: projectId },
+      select: { fieldMappings: true },
+    });
+    const formLabels: Record<string, string> = 
+      ((project?.fieldMappings as any)?.formLabels) || {};
+
+    // 按表单统计
+    const formStatsRaw = await prisma.$queryRaw<Array<{
+      form_name: string;
+      total: bigint;
+      passed: bigint;
+      failed: bigint;
+    }>>`
+      SELECT 
+        form_name,
+        COUNT(*) as total,
+        COUNT(*) FILTER (WHERE status = 'PASS' OR status = 'GREEN') as passed,
+        COUNT(*) FILTER (WHERE status = 'FAIL' OR status = 'RED') as failed
+      FROM (
+        SELECT DISTINCT ON (record_id, form_name)
+          record_id, form_name, status
+        FROM iit_schema.qc_logs
+        WHERE project_id = ${projectId} AND form_name IS NOT NULL
+        ORDER BY record_id, form_name, created_at DESC
+      ) latest_logs
+      GROUP BY form_name
+      ORDER BY form_name
+    `;
+
+    return formStatsRaw.map(row => {
+      const total = Number(row.total);
+      const passed = Number(row.passed);
+      const failed = Number(row.failed);
+      return {
+        formName: row.form_name,
+        formLabel: formLabels[row.form_name] || this.formatFormName(row.form_name),
+        totalChecks: total,
+        passed,
+        failed,
+        passRate: total > 0 ? Math.round((passed / total) * 100 * 10) / 10 : 0,
+      };
+    });
+  }
+
+  /**
+   * 格式化表单名称
+   */
+  private formatFormName(formName: string): string {
+    return formName
+      .replace(/_/g, ' ')
+      .replace(/\b\w/g, c => c.toUpperCase());
+  }
+
+  /**
+   * V2.1: 按受试者分组问题
+   */
+  private groupIssuesByRecord(issues: ReportIssue[]): GroupedIssues[] {
+    const grouped = new Map<string, ReportIssue[]>();
+    
+    for (const issue of issues) {
+      const existing = grouped.get(issue.recordId) || [];
+      existing.push(issue);
+      grouped.set(issue.recordId, existing);
+    }
+
+    return Array.from(grouped.entries())
+      .map(([recordId, issues]) => ({
+        recordId,
+        issueCount: issues.length,
+        issues,
+      }))
+      .sort((a, b) => a.recordId.localeCompare(b.recordId, undefined, { numeric: true }));
+  }
+
+  /**
+   * V2.1: 计算 Top Issues 统计
+   */
+  private calculateTopIssues(issues: ReportIssue[], limit: number = 5): TopIssue[] {
+    const ruleStats = new Map<string, { ruleName: string; ruleId: string; records: Set<string> }>();
+
+    for (const issue of issues) {
+      const key = issue.ruleId || issue.ruleName;
+      const existing = ruleStats.get(key) || {
+        ruleName: issue.ruleName,
+        ruleId: issue.ruleId,
+        records: new Set<string>(),
+      };
+      existing.records.add(issue.recordId);
+      ruleStats.set(key, existing);
+    }
+
+    return Array.from(ruleStats.values())
+      .map(stat => ({
+        ruleName: stat.ruleName,
+        ruleId: stat.ruleId,
+        count: stat.records.size,
+        affectedRecords: Array.from(stat.records),
+      }))
+      .sort((a, b) => b.count - a.count)
+      .slice(0, limit);
+  }
+
+  /**
+   * 构建 LLM 友好的 XML 报告
+   * 
+   * V2.1 优化：
+   * - 按受试者分组
+   * - 添加 Top Issues 统计
+   * - 自包含的 message 格式
+   */
+  private buildLlmXmlReport(
+    projectId: string,
+    projectName: string,
+    summary: ReportSummary,
+    criticalIssues: ReportIssue[],
+    warningIssues: ReportIssue[],
+    formStats: FormStats[]
+  ): string {
+    const now = new Date().toISOString();
+
+    // V2.1: 计算 Top Issues
+    const allIssues = [...criticalIssues, ...warningIssues];
+    const topIssues = this.calculateTopIssues(allIssues);
+
+    // V2.1: 按受试者分组
+    const groupedCritical = this.groupIssuesByRecord(criticalIssues);
+    const failedRecordCount = groupedCritical.length;
+
+    let xml = `<?xml version="1.0" encoding="UTF-8"?>
+<qc_context project_id="${projectId}" project_name="${this.escapeXml(projectName)}" generated="${now}">
+
+  <!-- 1. 宏观统计 (Aggregate) -->
+  <summary>
+    - 状态: ${failedRecordCount}/${summary.totalRecords} 记录存在严重违规 (${summary.totalRecords > 0 ? Math.round((failedRecordCount / summary.totalRecords) * 100) : 0}% Fail)
+    - 通过率: ${summary.passRate}%
+    - 严重问题: ${summary.criticalIssues} | 警告: ${summary.warningIssues}
+${topIssues.length > 0 ? `    - Top ${Math.min(3, topIssues.length)} 问题:
+${topIssues.slice(0, 3).map((t, i) => `      ${i + 1}. ${t.ruleName} (${t.count}人)`).join('\n')}` : ''}
+  </summary>
+
+`;
+
+    // V3.1: 严重问题详情（按受试者分组，显示所有问题）
+    if (groupedCritical.length > 0) {
+      xml += `  <!-- 2. 严重问题详情 (按受试者分组) -->\n`;
+      xml += `  <critical_issues record_count="${groupedCritical.length}" issue_count="${criticalIssues.length}">\n\n`;
+      
+      for (const group of groupedCritical) {
+        xml += `    <record id="${group.recordId}">\n`;
+        xml += `      **严重违规 (${group.issueCount}项)**:\n`;
+        
+        // V3.1: 显示所有问题，不再限制
+        for (let i = 0; i < group.issues.length; i++) {
+          const issue = group.issues[i];
+          const llmLine = this.buildLlmIssueLine(issue, i + 1);
+          xml += `      ${llmLine}\n`;
+        }
+        
+        xml += `    </record>\n\n`;
+      }
+      
+      xml += `  </critical_issues>\n\n`;
+    } else {
+      xml += `  <critical_issues record_count="0" issue_count="0" />\n\n`;
+    }
+
+    // V3.1: 警告问题（显示所有）
+    const groupedWarning = this.groupIssuesByRecord(warningIssues);
+    if (groupedWarning.length > 0) {
+      xml += `  <!-- 3. 警告问题 -->\n`;
+      xml += `  <warning_issues record_count="${groupedWarning.length}" issue_count="${warningIssues.length}">\n`;
+      
+      for (const group of groupedWarning) {
+        xml += `    <record id="${group.recordId}">\n`;
+        xml += `      **警告 (${group.issueCount}项)**:\n`;
+        for (let i = 0; i < group.issues.length; i++) {
+          const issue = group.issues[i];
+          const llmLine = this.buildLlmIssueLine(issue, i + 1);
+          xml += `      ${llmLine}\n`;
+        }
+        xml += `    </record>\n`;
+      }
+      
+      xml += `  </warning_issues>\n\n`;
+    }
+
+    xml += `</qc_context>`;
+
+    return xml;
+  }
+
+  /**
+   * V2.1: 构建 LLM 友好的单行问题描述
+   * 
+   * 格式: [规则ID] **问题类型**: 当前 **值** (标准: xxx)
+   */
+  private buildLlmIssueLine(issue: ReportIssue, index: number): string {
+    const ruleId = issue.ruleId !== 'unknown' ? `[${issue.ruleId}]` : '';
+    
+    // 尝试使用 llmMessage（如果 HardRuleEngine 已经生成）
+    if (issue.message && issue.message.includes('**')) {
+      // 已经是自包含格式
+      return `${index}. ${ruleId} ${issue.message}`;
+    }
+
+    // 回退：手动构建
+    const actualDisplay = issue.actualValue !== undefined && issue.actualValue !== null && issue.actualValue !== ''
+      ? `**${issue.actualValue}**`
+      : '**空**';
+    
+    const expectedDisplay = issue.expectedValue 
+      ? ` (标准: ${issue.expectedValue})`
+      : '';
+
+    return `${index}. ${ruleId} **${issue.ruleName}**: 当前值 ${actualDisplay}${expectedDisplay}`;
+  }
+
+  /**
+   * 构建原始 XML 报告（兼容旧格式）
+   */
+  private buildLegacyXmlReport(
+    projectId: string,
+    projectName: string,
+    summary: ReportSummary,
+    criticalIssues: ReportIssue[],
+    warningIssues: ReportIssue[],
+    formStats: FormStats[]
+  ): string {
+    const now = new Date().toISOString();
+
+    let xml = `<?xml version="1.0" encoding="UTF-8"?>
+<qc_report project_id="${projectId}" project_name="${this.escapeXml(projectName)}" generated="${now}">
+  
+  <summary>
+    <total_records>${summary.totalRecords}</total_records>
+    <completed_records>${summary.completedRecords}</completed_records>
+    <critical_issues>${summary.criticalIssues}</critical_issues>
+    <warning_issues>${summary.warningIssues}</warning_issues>
+    <pending_queries>${summary.pendingQueries}</pending_queries>
+    <pass_rate>${summary.passRate}%</pass_rate>
+    <last_qc_time>${summary.lastQcTime || 'N/A'}</last_qc_time>
+  </summary>
+
+`;
+
+    // V3.1: 严重问题列表（显示所有）
+    if (criticalIssues.length > 0) {
+      xml += `  <critical_issues count="${criticalIssues.length}">\n`;
+      for (const issue of criticalIssues) {
+        xml += this.buildIssueXml(issue, '    ');
+      }
+      xml += `  </critical_issues>\n\n`;
+    } else {
+      xml += `  <critical_issues count="0" />\n\n`;
+    }
+
+    // V3.1: 警告问题列表（显示所有）
+    if (warningIssues.length > 0) {
+      xml += `  <warning_issues count="${warningIssues.length}">\n`;
+      for (const issue of warningIssues) {
+        xml += this.buildIssueXml(issue, '    ');
+      }
+      xml += `  </warning_issues>\n\n`;
+    } else {
+      xml += `  <warning_issues count="0" />\n\n`;
+    }
+
+    // 表单统计
+    if (formStats.length > 0) {
+      xml += `  <form_statistics>\n`;
+      for (const form of formStats) {
+        xml += `    <form name="${this.escapeXml(form.formName)}" label="${this.escapeXml(form.formLabel)}">\n`;
+        xml += `      <total_checks>${form.totalChecks}</total_checks>\n`;
+        xml += `      <passed>${form.passed}</passed>\n`;
+        xml += `      <failed>${form.failed}</failed>\n`;
+        xml += `      <pass_rate>${form.passRate}%</pass_rate>\n`;
+        xml += `    </form>\n`;
+      }
+      xml += `  </form_statistics>\n\n`;
+    }
+
+    xml += `</qc_report>`;
+
+    return xml;
+  }
+
+  /**
+   * 构建单个问题的 XML
+   */
+  private buildIssueXml(issue: ReportIssue, indent: string): string {
+    let xml = `${indent}<issue record="${issue.recordId}" rule="${this.escapeXml(issue.ruleId)}" severity="${issue.severity}">\n`;
+    xml += `${indent}  <rule_name>${this.escapeXml(issue.ruleName)}</rule_name>\n`;
+    xml += `${indent}  <message>${this.escapeXml(issue.message)}</message>\n`;
+    
+    if (issue.field) {
+      xml += `${indent}  <field>${this.escapeXml(String(issue.field))}</field>\n`;
+    }
+    if (issue.actualValue !== undefined) {
+      xml += `${indent}  <actual_value>${this.escapeXml(String(issue.actualValue))}</actual_value>\n`;
+    }
+    if (issue.expectedValue !== undefined) {
+      xml += `${indent}  <expected_value>${this.escapeXml(String(issue.expectedValue))}</expected_value>\n`;
+    }
+    if (issue.evidence && Object.keys(issue.evidence).length > 0) {
+      xml += `${indent}  <evidence>\n`;
+      for (const [key, value] of Object.entries(issue.evidence)) {
+        xml += `${indent}    <${this.escapeXml(key)}>${this.escapeXml(String(value))}</${this.escapeXml(key)}>\n`;
+      }
+      xml += `${indent}  </evidence>\n`;
+    }
+    
+    xml += `${indent}  <detected_at>${issue.detectedAt}</detected_at>\n`;
+    xml += `${indent}</issue>\n`;
+    
+    return xml;
+  }
+
+  /**
+   * XML 转义
+   */
+  private escapeXml(str: string): string {
+    return str
+      .replace(/&/g, '&amp;')
+      .replace(/</g, '&lt;')
+      .replace(/>/g, '&gt;')
+      .replace(/"/g, '&quot;')
+      .replace(/'/g, '&apos;');
+  }
+
+  /**
+   * 缓存报告
+   */
+  private async cacheReport(report: QcReport): Promise<void> {
+    try {
+      await prisma.iitQcReport.create({
+        data: {
+          projectId: report.projectId,
+          reportType: report.reportType,
+          summary: report.summary as any,
+          issues: {
+            critical: report.criticalIssues,
+            warning: report.warningIssues,
+            formStats: report.formStats,
+            topIssues: report.topIssues,           // V2.1
+            groupedIssues: report.groupedIssues,   // V2.1
+            legacyXml: report.legacyXml,           // V2.1
+          } as any,
+          llmReport: report.llmFriendlyXml,
+          generatedAt: new Date(report.generatedAt),
+          expiresAt: report.expiresAt ? new Date(report.expiresAt) : null,
+        },
+      });
+
+      logger.debug('[QcReportService] Report cached', {
+        projectId: report.projectId,
+        reportType: report.reportType,
+      });
+    } catch (error: any) {
+      logger.warn('[QcReportService] Failed to cache report', {
+        projectId: report.projectId,
+        error: error.message,
+      });
+    }
+  }
+
+  /**
+   * 获取 LLM 友好的报告（用于问答）
+   * 
+   * @param projectId 项目 ID
+   * @param format 格式：'llm-friendly' (默认) 或 'xml' (兼容格式)
+   * @returns XML 报告
+   */
+  async getLlmReport(projectId: string, format: 'llm-friendly' | 'xml' = 'llm-friendly'): Promise<string> {
+    const report = await this.getReport(projectId);
+    
+    if (format === 'xml') {
+      return report.legacyXml || report.llmFriendlyXml;
+    }
+    
+    return report.llmFriendlyXml;
+  }
+
+  /**
+   * V2.1: 获取 Top Issues 统计
+   */
+  async getTopIssues(projectId: string, limit: number = 5): Promise<TopIssue[]> {
+    const report = await this.getReport(projectId);
+    return report.topIssues.slice(0, limit);
+  }
+
+  /**
+   * V2.1: 获取按受试者分组的问题
+   */
+  async getGroupedIssues(projectId: string): Promise<GroupedIssues[]> {
+    const report = await this.getReport(projectId);
+    return report.groupedIssues;
+  }
+
+  /**
+   * 强制刷新报告
+   * 
+   * @param projectId 项目 ID
+   * @returns 新生成的报告
+   */
+  async refreshReport(projectId: string): Promise<QcReport> {
+    return this.getReport(projectId, { forceRefresh: true });
+  }
+
+  /**
+   * 清理过期报告
+   */
+  async cleanupExpiredReports(): Promise<number> {
+    const result = await prisma.iitQcReport.deleteMany({
+      where: {
+        expiresAt: {
+          lt: new Date(),
+        },
+      },
+    });
+
+    logger.info('[QcReportService] Cleaned up expired reports', {
+      count: result.count,
+    });
+
+    return result.count;
+  }
+}
+
+// 单例导出
+export const QcReportService = new QcReportServiceClass();
diff --git a/backend/src/modules/iit-manager/services/ToolsService.ts b/backend/src/modules/iit-manager/services/ToolsService.ts
index 918293ae..c8b1667f 100644
--- a/backend/src/modules/iit-manager/services/ToolsService.ts
+++ b/backend/src/modules/iit-manager/services/ToolsService.ts
@@ -17,6 +17,7 @@ import { PrismaClient } from '@prisma/client';
 import { logger } from '../../../common/logging/index.js';
 import { RedcapAdapter } from '../adapters/RedcapAdapter.js';
 import { createHardRuleEngine, QCResult } from '../engines/HardRuleEngine.js';
+import { createSkillRunner } from '../engines/SkillRunner.js';
 
 const prisma = new PrismaClient();
 
@@ -430,10 +431,10 @@ export class ToolsService {
       }
     });
 
-    // 3. batch_quality_check - 批量质控
+    // 3. batch_quality_check - 批量质控（事件级）
     this.registerTool({
       name: 'batch_quality_check',
-      description: '对所有患者数据执行批量质控检查，返回汇总统计。',
+      description: '对所有患者数据执行事件级批量质控检查，每个 record+event 组合独立质控。',
       category: 'compute',
       parameters: [],
       execute: async (params, context) => {
@@ -442,66 +443,72 @@ export class ToolsService {
         }
 
         try {
-          // 1. 获取所有记录
-          const allRecords = await context.redcapAdapter.exportRecords({});
-          if (allRecords.length === 0) {
+          // ⭐ 使用 SkillRunner 进行事件级质控
+          const runner = await createSkillRunner(context.projectId);
+          const results = await runner.runByTrigger('manual');
+
+          if (results.length === 0) {
             return {
               success: true,
-              data: { message: '暂无记录' }
+              data: { message: '暂无记录或未配置质控规则' }
             };
           }
 
-          // 2. 去重
-          const recordMap = new Map<string, Record<string, any>>();
-          for (const r of allRecords) {
-            if (!recordMap.has(r.record_id)) {
-              recordMap.set(r.record_id, r);
-            }
+          // 统计汇总（按 record+event 组合）
+          const passCount = results.filter(r => r.overallStatus === 'PASS').length;
+          const failCount = results.filter(r => r.overallStatus === 'FAIL').length;
+          const warningCount = results.filter(r => r.overallStatus === 'WARNING').length;
+          const uncertainCount = results.filter(r => r.overallStatus === 'UNCERTAIN').length;
+
+          // 按 recordId 分组统计
+          const recordEventMap = new Map<string, { events: number; passed: number; failed: number }>();
+          for (const r of results) {
+            const stats = recordEventMap.get(r.recordId) || { events: 0, passed: 0, failed: 0 };
+            stats.events++;
+            if (r.overallStatus === 'PASS') stats.passed++;
+            if (r.overallStatus === 'FAIL') stats.failed++;
+            recordEventMap.set(r.recordId, stats);
           }
 
-          // 3. 批量质控
-          const engine = await createHardRuleEngine(context.projectId);
-          const records = Array.from(recordMap.entries()).map(([id, data]) => ({
-            recordId: id,
-            data
-          }));
-
-          const qcResults = engine.executeBatch(records);
-
-          // 4. 统计汇总
-          const passCount = qcResults.filter(r => r.overallStatus === 'PASS').length;
-          const failCount = qcResults.filter(r => r.overallStatus === 'FAIL').length;
-          const warningCount = qcResults.filter(r => r.overallStatus === 'WARNING').length;
-
-          // 5. 问题记录
-          const problemRecords = qcResults
+          // 问题记录（取前10个问题 record+event 组合）
+          const problemRecords = results
             .filter(r => r.overallStatus !== 'PASS')
             .slice(0, 10)
             .map(r => ({
               recordId: r.recordId,
+              eventName: r.eventName,
+              eventLabel: r.eventLabel,
+              forms: r.forms,
               status: r.overallStatus,
-              issues: [...r.errors, ...r.warnings].slice(0, 3).map(i => ({
+              issues: r.allIssues?.slice(0, 3).map((i: any) => ({
                 rule: i.ruleName,
-                message: i.message
-              }))
+                message: i.message,
+                severity: i.severity
+              })) || []
             }));
 
           return {
             success: true,
             data: {
-              totalRecords: records.length,
+              totalRecordEventCombinations: results.length,
+              uniqueRecords: recordEventMap.size,
               summary: {
                 pass: passCount,
                 fail: failCount,
                 warning: warningCount,
-                passRate: `${((passCount / records.length) * 100).toFixed(1)}%`
+                uncertain: uncertainCount,
+                passRate: `${((passCount / results.length) * 100).toFixed(1)}%`
               },
-              problemRecords
+              problemRecords,
+              recordStats: Array.from(recordEventMap.entries()).map(([recordId, stats]) => ({
+                recordId,
+                ...stats
+              }))
             },
             metadata: {
               executionTime: 0,
-              recordCount: records.length,
-              source: 'HardRuleEngine'
+              source: 'SkillRunner-EventLevel',
+              version: 'v3.1'
             }
           };
         } catch (error: any) {
diff --git a/backend/src/modules/iit-manager/services/index.ts b/backend/src/modules/iit-manager/services/index.ts
new file mode 100644
index 00000000..01ece669
--- /dev/null
+++ b/backend/src/modules/iit-manager/services/index.ts
@@ -0,0 +1,10 @@
+/**
+ * IIT Manager Services 导出
+ */
+
+export * from './ChatService.js';
+export * from './PromptBuilder.js';
+export * from './QcService.js';
+export * from './QcReportService.js';
+export * from './SyncManager.js';
+export * from './ToolsService.js';
diff --git a/backend/test-event-level-qc.ts b/backend/test-event-level-qc.ts
new file mode 100644
index 00000000..e8144e3b
--- /dev/null
+++ b/backend/test-event-level-qc.ts
@@ -0,0 +1,171 @@
+/**
+ * 测试脚本：验证事件级质控功能
+ * 
+ * V3.1 变更：
+ * - 每个 record + event 作为独立单元质控
+ * - 规则支持 applicableEvents 和 applicableForms 配置
+ * - 不再合并事件数据
+ */
+import { PrismaClient } from '@prisma/client';
+import { createSkillRunner } from './src/modules/iit-manager/engines/SkillRunner.js';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('📋 V3.1 事件级质控测试');
+  console.log('='.repeat(60));
+
+  // 1. 获取项目配置
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+  });
+
+  if (!project) {
+    console.log('❌ 未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  console.log(`\n✅ 项目: ${project.name} (${project.id})`);
+
+  // ===============================
+  // 测试 1：验证事件级数据获取
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 1：验证事件级数据获取');
+  console.log('='.repeat(60));
+
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+  
+  // 获取 Record 1 的事件级数据（不合并）
+  const record1Events = await adapter.getAllRecordsByEvent({ recordId: '1' });
+  
+  console.log(`\nRecord 1 共有 ${record1Events.length} 个事件（不合并）:`);
+  for (const event of record1Events) {
+    console.log(`\n  📁 事件: ${event.eventLabel} (${event.eventName})`);
+    console.log(`     表单: ${event.forms.join(', ')}`);
+    console.log(`     数据示例: age=${event.data.age ?? '(空)'}, cmss_complete=${event.data.cmss_complete ?? '(空)'}`);
+  }
+
+  // ===============================
+  // 测试 2：验证事件级质控执行
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 2：执行事件级质控 (Record 1)');
+  console.log('='.repeat(60));
+
+  const runner = createSkillRunner(project.id);
+  
+  // 只质控 Record 1
+  const results = await runner.runByTrigger('manual', { recordId: '1' });
+  
+  console.log(`\n质控完成! 处理了 ${results.length} 个 record+event 组合:`);
+  
+  for (const result of results) {
+    const issueCount = result.allIssues.length;
+    const statusIcon = result.overallStatus === 'PASS' ? '✅' : 
+                       result.overallStatus === 'WARNING' ? '⚠️' : '🔴';
+    
+    console.log(`\n  ${statusIcon} Record ${result.recordId} - ${result.eventLabel}`);
+    console.log(`     事件: ${result.eventName}`);
+    console.log(`     表单: ${result.forms?.join(', ') || '(无)'}`);
+    console.log(`     状态: ${result.overallStatus}`);
+    console.log(`     问题数: ${issueCount}`);
+    
+    if (issueCount > 0) {
+      console.log(`     问题详情:`);
+      for (const issue of result.allIssues.slice(0, 3)) {
+        console.log(`       - ${issue.ruleName}: ${issue.llmMessage || issue.message}`);
+      }
+      if (issueCount > 3) {
+        console.log(`       ... 还有 ${issueCount - 3} 个问题`);
+      }
+    }
+  }
+
+  // ===============================
+  // 测试 3：验证全量质控（所有记录所有事件）
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 3：全量质控统计');
+  console.log('='.repeat(60));
+
+  const allResults = await runner.runByTrigger('manual');
+  
+  // 按事件类型统计
+  const eventStats = new Map<string, { total: number; pass: number; fail: number; warning: number }>();
+  
+  for (const result of allResults) {
+    const eventLabel = result.eventLabel || 'Unknown';
+    if (!eventStats.has(eventLabel)) {
+      eventStats.set(eventLabel, { total: 0, pass: 0, fail: 0, warning: 0 });
+    }
+    const stats = eventStats.get(eventLabel)!;
+    stats.total++;
+    if (result.overallStatus === 'PASS') stats.pass++;
+    else if (result.overallStatus === 'FAIL') stats.fail++;
+    else if (result.overallStatus === 'WARNING') stats.warning++;
+  }
+
+  console.log(`\n质控总数: ${allResults.length} 个 record+event 组合`);
+  console.log(`\n按事件类型统计:`);
+  for (const [event, stats] of eventStats) {
+    console.log(`  ${event}: 总${stats.total}, 通过${stats.pass}, 警告${stats.warning}, 失败${stats.fail}`);
+  }
+
+  // 问题分布
+  const ruleStats = new Map<string, number>();
+  for (const result of allResults) {
+    for (const issue of result.allIssues) {
+      const ruleName = issue.ruleName || 'Unknown';
+      ruleStats.set(ruleName, (ruleStats.get(ruleName) || 0) + 1);
+    }
+  }
+
+  console.log(`\n问题分布:`);
+  for (const [rule, count] of ruleStats) {
+    console.log(`  ${rule}: ${count} 次`);
+  }
+
+  // ===============================
+  // 测试 4：验证数据库日志（包含事件信息）
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 4：验证数据库日志');
+  console.log('='.repeat(60));
+
+  const recentLogs = await prisma.iitQcLog.findMany({
+    where: { projectId: project.id },
+    orderBy: { createdAt: 'desc' },
+    take: 5,
+    select: {
+      id: true,
+      recordId: true,
+      eventId: true,
+      qcType: true,
+      formName: true,
+      status: true,
+      createdAt: true,
+    }
+  });
+
+  console.log(`\n最近 ${recentLogs.length} 条质控日志:`);
+  for (const log of recentLogs) {
+    console.log(`  [${log.recordId}] 事件: ${log.eventId || '(无)'}`);
+    console.log(`     类型: ${log.qcType}, 表单: ${log.formName || '(无)'}, 状态: ${log.status}`);
+  }
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ V3.1 事件级质控测试完成');
+  console.log('='.repeat(60));
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/backend/test-form-status.ts b/backend/test-form-status.ts
new file mode 100644
index 00000000..1781fcb7
--- /dev/null
+++ b/backend/test-form-status.ts
@@ -0,0 +1,164 @@
+/**
+ * 测试脚本：验证表单状态和计算字段获取
+ */
+import { PrismaClient } from '@prisma/client';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('📋 表单状态和计算字段测试');
+  console.log('='.repeat(60));
+
+  // 1. 获取项目配置
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+  });
+
+  if (!project) {
+    console.log('❌ 未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+
+  // ===============================
+  // 测试 1：获取计算字段列表
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 1：计算字段列表');
+  console.log('='.repeat(60));
+
+  const calcFields = await adapter.getCalculatedFields();
+  console.log(`\n共有 ${calcFields.length} 个计算字段:`);
+  for (const field of calcFields) {
+    console.log(`  📐 ${field.fieldName} (${field.fieldLabel})`);
+    console.log(`     表单: ${field.formName}`);
+    console.log(`     公式: ${field.calculation.substring(0, 80)}${field.calculation.length > 80 ? '...' : ''}`);
+  }
+
+  // ===============================
+  // 测试 2：获取表单完成状态
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 2：表单完成状态 (前 5 条记录)');
+  console.log('='.repeat(60));
+
+  const formStatus = await adapter.getFormCompletionStatus();
+  
+  // 只显示前 5 条
+  for (const record of formStatus.slice(0, 5)) {
+    console.log(`\n  [Record ${record.recordId}] ${record.allComplete ? '✅ 全部完成' : '⚠️ 部分未完成'}`);
+    
+    // 统计各状态数量
+    const statusCounts = { Complete: 0, Unverified: 0, Incomplete: 0 };
+    for (const [formName, status] of Object.entries(record.forms)) {
+      statusCounts[status.statusLabel]++;
+    }
+    console.log(`     Complete: ${statusCounts.Complete}, Unverified: ${statusCounts.Unverified}, Incomplete: ${statusCounts.Incomplete}`);
+
+    // 显示非 Complete 的表单
+    const nonComplete = Object.entries(record.forms)
+      .filter(([_, s]) => s.statusLabel !== 'Complete')
+      .map(([name, s]) => `${name}(${s.statusLabel})`);
+    
+    if (nonComplete.length > 0 && nonComplete.length <= 5) {
+      console.log(`     未完成: ${nonComplete.join(', ')}`);
+    } else if (nonComplete.length > 5) {
+      console.log(`     未完成: ${nonComplete.slice(0, 5).join(', ')}... (共${nonComplete.length}个)`);
+    }
+  }
+
+  // ===============================
+  // 测试 3：单个表单状态检查
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 3：检查 Record 3 的人口学表单状态');
+  console.log('='.repeat(60));
+
+  const demoFormStatus = await adapter.isFormComplete('3', 'basic_demography_form');
+  console.log(`\n  Record 3 - basic_demography_form:`);
+  console.log(`    状态: ${demoFormStatus.statusLabel} (${demoFormStatus.status})`);
+  console.log(`    完成: ${demoFormStatus.isComplete ? '是' : '否'}`);
+
+  // ===============================
+  // 测试 4：关联分析 - 计算字段 vs 表单状态
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 4：计算字段与表单状态关联分析');
+  console.log('='.repeat(60));
+
+  // 获取所有记录数据
+  const allRecords = await adapter.getAllRecordsMerged();
+  
+  console.log('\n  分析计算字段 "age" 与表单状态的关系:');
+  console.log('  ' + '-'.repeat(50));
+  
+  for (const record of allRecords.slice(0, 5)) {
+    const recId = record.record_id;
+    const age = record.age;
+    const dob = record.date_of_birth;
+    
+    // 获取该记录的表单状态
+    const statusInfo = formStatus.find(s => s.recordId === recId);
+    const demoStatus = statusInfo?.forms['basic_demography_form']?.statusLabel || 'Unknown';
+    
+    const ageDisplay = age !== undefined && age !== '' ? age : '(空)';
+    console.log(`  Record ${recId}: age=${ageDisplay}, dob=${dob || '(空)'}, 表单状态=${demoStatus}`);
+  }
+
+  // ===============================
+  // 测试 5：按事件维度的表单完成状态（正确方式）
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 5：按事件维度的表单完成状态 (Record 1)');
+  console.log('='.repeat(60));
+
+  const eventStatus = await adapter.getFormCompletionStatusByEvent('1');
+  
+  console.log(`\nRecord 1 共有 ${eventStatus.length} 个事件:`);
+  for (const event of eventStatus) {
+    const statusIcon = event.eventComplete ? '✅' : '⚠️';
+    console.log(`\n  ${statusIcon} 事件: ${event.eventLabel} (${event.eventName})`);
+    
+    for (const [formName, status] of Object.entries(event.forms)) {
+      const icon = status.status === 2 ? '✅' : (status.status === 1 ? '🟡' : '🔴');
+      console.log(`     ${icon} ${formName}: ${status.statusLabel}`);
+    }
+  }
+
+  // ===============================
+  // 测试 6：获取表单-事件映射
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 6：表单-事件映射统计');
+  console.log('='.repeat(60));
+
+  const formEventMapping = await adapter.getFormEventMapping();
+  console.log(`\n表单-事件映射总数: ${formEventMapping.length}`);
+  
+  // 按事件分组统计
+  const eventFormCount = new Map<string, number>();
+  for (const m of formEventMapping) {
+    eventFormCount.set(m.eventLabel, (eventFormCount.get(m.eventLabel) || 0) + 1);
+  }
+  
+  console.log('\n各事件的表单数:');
+  for (const [event, count] of eventFormCount) {
+    console.log(`  ${event}: ${count} 个表单`);
+  }
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ 测试完成');
+  console.log('='.repeat(60));
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/backend/test-redcap-calculated-fields.ts b/backend/test-redcap-calculated-fields.ts
new file mode 100644
index 00000000..5c77e9e3
--- /dev/null
+++ b/backend/test-redcap-calculated-fields.ts
@@ -0,0 +1,271 @@
+/**
+ * 测试脚本：验证 REDCap 计算字段导出和全量质控
+ * 
+ * 测试内容：
+ * 1. 验证 exportCalculatedFields 参数是否生效
+ * 2. 检查年龄等计算字段是否正确获取
+ * 3. 执行全量质控并查看结果
+ */
+import { PrismaClient } from '@prisma/client';
+import { RedcapAdapter } from './src/modules/iit-manager/adapters/RedcapAdapter.js';
+import { createSkillRunner } from './src/modules/iit-manager/engines/SkillRunner.js';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('📋 REDCap 计算字段导出测试');
+  console.log('='.repeat(60));
+
+  // 1. 获取项目配置
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+    select: { 
+      id: true, 
+      name: true, 
+      redcapUrl: true, 
+      redcapApiToken: true,
+      fieldMappings: true 
+    }
+  });
+
+  if (!project) {
+    console.log('❌ 未找到 test0207 项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  console.log(`\n✅ 找到项目: ${project.name} (ID: ${project.id})`);
+
+  // 2. 创建 REDCap 适配器（使用默认的 exportCalculatedFields=true）
+  const adapter = new RedcapAdapter(project.redcapUrl, project.redcapApiToken);
+
+  // ===============================
+  // 测试 1：导出单条记录
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 1：导出 Record ID=1 的数据');
+  console.log('='.repeat(60));
+
+  try {
+    const record = await adapter.getRecordById('1');
+    
+    if (!record) {
+      console.log('❌ 未找到 Record ID=1');
+    } else {
+      // 显示所有字段
+      console.log('\n📋 所有字段及其值:');
+      const sortedKeys = Object.keys(record).sort();
+      for (const key of sortedKeys) {
+        const value = record[key];
+        const displayValue = value === '' ? '(空)' : value;
+        console.log(`  ${key}: ${displayValue}`);
+      }
+
+      // 特别检查关键字段
+      console.log('\n🔍 关键字段检查:');
+      const keyFields = ['record_id', 'age', '年龄', 'date_of_birth', '出生日期', 'gender', '性别'];
+      for (const field of keyFields) {
+        if (record[field] !== undefined) {
+          console.log(`  ✅ ${field} = ${record[field] || '(空)'}`);
+        }
+      }
+
+      // 检查是否有年龄相关字段
+      console.log('\n🔍 年龄相关字段（模糊匹配）:');
+      const ageRelated = Object.entries(record).filter(([key]) => 
+        key.toLowerCase().includes('age') || 
+        key.toLowerCase().includes('年龄') ||
+        key.toLowerCase().includes('birth') ||
+        key.toLowerCase().includes('出生')
+      );
+      if (ageRelated.length > 0) {
+        for (const [key, value] of ageRelated) {
+          console.log(`  ${key} = ${value || '(空)'}`);
+        }
+      } else {
+        console.log('  ⚠️ 未找到年龄相关字段');
+      }
+    }
+  } catch (error: any) {
+    console.error('❌ REDCap 查询失败:', error.message);
+  }
+
+  // ===============================
+  // 测试 2：导出所有记录并统计
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 2：导出所有记录统计');
+  console.log('='.repeat(60));
+
+  try {
+    const allRecords = await adapter.getAllRecordsMerged();
+    console.log(`\n📋 共获取 ${allRecords.length} 条记录`);
+
+    // 检查每条记录的年龄字段
+    const ageField = 'age'; // 假设字段名为 age
+    let hasAge = 0;
+    let noAge = 0;
+
+    for (const record of allRecords) {
+      // 查找任何包含 age 的字段
+      const ageValue = record['age'] ?? record['Age'] ?? record['年龄'];
+      if (ageValue !== undefined && ageValue !== '') {
+        hasAge++;
+      } else {
+        noAge++;
+      }
+    }
+
+    console.log(`  有年龄值的记录: ${hasAge}`);
+    console.log(`  无年龄值的记录: ${noAge}`);
+
+    // 显示前 3 条记录的摘要
+    console.log('\n📋 前 3 条记录摘要:');
+    for (let i = 0; i < Math.min(3, allRecords.length); i++) {
+      const r = allRecords[i];
+      console.log(`  [Record ${r.record_id}] age=${r.age ?? '(无)'}, date_of_birth=${r.date_of_birth ?? '(无)'}`);
+    }
+
+  } catch (error: any) {
+    console.error('❌ 导出所有记录失败:', error.message);
+  }
+
+  // ===============================
+  // 测试 3：检查质控规则
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 3：检查项目质控规则');
+  console.log('='.repeat(60));
+
+  const skills = await prisma.iitSkill.findMany({
+    where: { projectId: project.id },
+    select: { id: true, name: true, config: true, isActive: true }
+  });
+
+  console.log(`\n📋 项目共有 ${skills.length} 个 Skill:`);
+  for (const skill of skills) {
+    console.log(`  ${skill.isActive ? '✅' : '❌'} ${skill.name} (${skill.id})`);
+    
+    // 显示规则摘要
+    const config = skill.config as any;
+    if (config?.rules && Array.isArray(config.rules)) {
+      console.log(`     规则数: ${config.rules.length}`);
+      for (const rule of config.rules.slice(0, 3)) {
+        console.log(`       - ${rule.name}: field=${rule.field}`);
+      }
+      if (config.rules.length > 3) {
+        console.log(`       ... 还有 ${config.rules.length - 3} 条规则`);
+      }
+    }
+  }
+
+  // ===============================
+  // 测试 4：执行全量质控
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 4：执行全量质控');
+  console.log('='.repeat(60));
+
+  try {
+    const activeSkills = skills.filter(s => s.isActive);
+    if (activeSkills.length === 0) {
+      console.log('⚠️ 没有激活的 Skill，跳过质控测试');
+    } else {
+      console.log(`\n🚀 开始执行全量质控 (项目 ${project.id})...`);
+
+      // 使用 createSkillRunner 创建运行器
+      const runner = createSkillRunner(project.id);
+      
+      // 执行 manual 触发类型的质控（全量）
+      const results = await runner.runByTrigger('manual');
+
+      console.log(`\n✅ 质控完成! 处理了 ${results.length} 条记录`);
+      
+      // 统计所有问题
+      let totalIssues = 0;
+      const allIssuesList: any[] = [];
+      const ruleStats: Record<string, number> = {};
+      
+      for (const result of results) {
+        for (const skillResult of result.skillResults) {
+          for (const issue of skillResult.issues) {
+            totalIssues++;
+            allIssuesList.push({ recordId: result.recordId, ...issue });
+            const ruleName = issue.ruleName || 'unknown';
+            ruleStats[ruleName] = (ruleStats[ruleName] || 0) + 1;
+          }
+        }
+      }
+
+      console.log(`   发现问题总数: ${totalIssues}`);
+      
+      if (totalIssues > 0) {
+        console.log(`\n   问题分布:`);
+        for (const [ruleName, count] of Object.entries(ruleStats)) {
+          console.log(`     ${ruleName}: ${count} 次`);
+        }
+
+        // 显示前 5 个问题详情
+        console.log(`\n   前 5 个问题详情:`);
+        for (const issue of allIssuesList.slice(0, 5)) {
+          console.log(`     [Record ${issue.recordId}] ${issue.ruleName}`);
+          console.log(`        实际值: ${issue.actualValue ?? '(空)'}`);
+          console.log(`        期望: ${issue.expectedValue ?? '(未知)'}`);
+          console.log(`        消息: ${issue.llmMessage ?? issue.message}`);
+        }
+      }
+    }
+  } catch (error: any) {
+    console.error('❌ 质控执行失败:', error.message);
+    console.error(error.stack);
+  }
+
+  // ===============================
+  // 测试 5：查看最新质控日志
+  // ===============================
+  console.log('\n' + '='.repeat(60));
+  console.log('📊 测试 5：最新质控日志');
+  console.log('='.repeat(60));
+
+  const recentLogs = await prisma.iitQcLog.findMany({
+    where: { projectId: project.id },
+    orderBy: { createdAt: 'desc' },
+    take: 5,
+    select: {
+      id: true,
+      recordId: true,
+      status: true,
+      issues: true,
+      createdAt: true,
+    }
+  });
+
+  console.log(`\n📋 最近 ${recentLogs.length} 条质控日志:`);
+  for (const log of recentLogs) {
+    const issues = log.issues as any;
+    const issueCount = Array.isArray(issues) 
+      ? issues.length 
+      : (issues?.items?.length ?? 0);
+    
+    console.log(`  [${log.recordId}] ${log.status} - ${issueCount} 个问题 (${log.createdAt.toISOString()})`);
+    
+    // 显示问题详情
+    const issueList = Array.isArray(issues) ? issues : (issues?.items ?? []);
+    for (const issue of issueList.slice(0, 2)) {
+      console.log(`      ${issue.ruleName}: actualValue=${issue.actualValue ?? '(空)'}, expectedValue=${issue.expectedValue ?? '(未知)'}`);
+    }
+  }
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ 测试完成');
+  console.log('='.repeat(60));
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 测试脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/backend/update-skill-applicable-forms.ts b/backend/update-skill-applicable-forms.ts
new file mode 100644
index 00000000..178e0e54
--- /dev/null
+++ b/backend/update-skill-applicable-forms.ts
@@ -0,0 +1,115 @@
+/**
+ * 更新 Skill 配置：为规则添加 applicableForms
+ * 
+ * 确保规则只在包含对应表单的事件中执行
+ */
+import { PrismaClient } from '@prisma/client';
+
+const prisma = new PrismaClient();
+
+async function main() {
+  console.log('='.repeat(60));
+  console.log('📋 更新 Skill 配置：添加 applicableForms');
+  console.log('='.repeat(60));
+
+  // 1. 获取项目
+  const project = await prisma.iitProject.findFirst({
+    where: { name: { contains: 'test0207' } },
+  });
+
+  if (!project) {
+    console.log('❌ 未找到项目');
+    await prisma.$disconnect();
+    return;
+  }
+
+  console.log(`\n✅ 项目: ${project.name} (${project.id})`);
+
+  // 2. 获取当前 Skill 配置
+  const skill = await prisma.iitSkill.findFirst({
+    where: { projectId: project.id, isActive: true },
+  });
+
+  if (!skill) {
+    console.log('❌ 未找到激活的 Skill');
+    await prisma.$disconnect();
+    return;
+  }
+
+  console.log(`\n📋 当前 Skill: ${skill.name} (${skill.id})`);
+
+  const config = skill.config as any;
+  const rules = config?.rules || [];
+
+  console.log(`\n当前规则配置 (共 ${rules.length} 条):`);
+  for (const rule of rules) {
+    console.log(`  - ${rule.name}`);
+    console.log(`    field: ${rule.field}`);
+    console.log(`    applicableForms: ${JSON.stringify(rule.applicableForms || '(未设置)')}`);
+  }
+
+  // 3. 定义规则-表单映射
+  // 根据规则检查的字段，确定应该在哪个表单中检查
+  const ruleFormMapping: Record<string, string[]> = {
+    '年龄范围检查': ['basic_demography_form'],
+    '出生日期范围检查': ['basic_demography_form'],
+    '月经周期规律性检查': ['medical_history_and_diagnosis'],
+    'VAS 评分检查': ['cmss'],  // 或者 mcgill_sfmpq，根据实际字段确定
+    '知情同意书签署检查': ['informed_consent'],
+  };
+
+  // 4. 更新规则配置
+  console.log('\n' + '='.repeat(60));
+  console.log('📝 更新规则配置');
+  console.log('='.repeat(60));
+
+  const updatedRules = rules.map((rule: any) => {
+    const applicableForms = ruleFormMapping[rule.name];
+    if (applicableForms) {
+      console.log(`\n  ✅ ${rule.name}`);
+      console.log(`     添加 applicableForms: ${JSON.stringify(applicableForms)}`);
+      return {
+        ...rule,
+        applicableForms,
+      };
+    } else {
+      console.log(`\n  ⚠️ ${rule.name} - 未找到映射，保持不变`);
+      return rule;
+    }
+  });
+
+  // 5. 保存更新后的配置
+  const updatedConfig = {
+    ...config,
+    rules: updatedRules,
+  };
+
+  await prisma.iitSkill.update({
+    where: { id: skill.id },
+    data: { config: updatedConfig },
+  });
+
+  console.log('\n' + '='.repeat(60));
+  console.log('✅ 配置更新完成');
+  console.log('='.repeat(60));
+
+  // 6. 验证更新结果
+  const verifySkill = await prisma.iitSkill.findUnique({
+    where: { id: skill.id },
+  });
+
+  const verifyConfig = verifySkill?.config as any;
+  console.log('\n更新后的规则配置:');
+  for (const rule of verifyConfig?.rules || []) {
+    console.log(`  - ${rule.name}`);
+    console.log(`    applicableForms: ${JSON.stringify(rule.applicableForms || '(未设置)')}`);
+  }
+
+  await prisma.$disconnect();
+}
+
+main().catch(async (error) => {
+  console.error('❌ 脚本出错:', error);
+  await prisma.$disconnect();
+  process.exit(1);
+});
diff --git a/docs/00-系统总体设计/00-系统当前状态与开发指南.md b/docs/00-系统总体设计/00-系统当前状态与开发指南.md
index 75a13279..ebea4dda 100644
--- a/docs/00-系统总体设计/00-系统当前状态与开发指南.md
+++ b/docs/00-系统总体设计/00-系统当前状态与开发指南.md
@@ -1,11 +1,12 @@
 # AIclinicalresearch 系统当前状态与开发指南
 
-> **文档版本：** v4.8  
+> **文档版本：** v4.9  
 > **创建日期：** 2025-11-28  
 > **维护者：** 开发团队  
 > **最后更新：** 2026-02-08  
 > **🎉 重大里程碑：**  
-> - **2026-02-08：IIT 质控系统优化计划制定！** XML 临床切片格式 + 质控驾驶舱 + 方案 A 确认  
+> - **2026-02-08：IIT 事件级质控 V3.1 开发完成！** record+event 独立质控 + 规则动态过滤 + 报告去重 + AI对话增强  
+> - **2026-02-08：IIT 质控驾驶舱 UI 完成！** XML 临床切片格式 + 质控驾驶舱 + 热力图 + 详情抽屉  
 > - **2026-02-07：IIT 实时质控系统开发完成！** pg-boss 防抖 + 质控日志 + 录入汇总 + 管理端批量操作  
 > - **2026-02-05：IIT Manager Agent V2.9.1 架构设计完成！** 双脑架构 + 三层记忆 + 主动性增强 + 隐私合规  
 > - **2026-02-02：REDCap 生产环境部署完成！** ECS + RDS + HTTPS + 域名全部配置完成  
@@ -14,15 +15,14 @@
 > - **2026-01-25：Protocol Agent MVP完整交付！** 一键生成研究方案+Word导出  
 > - **2026-01-24：Protocol Agent 框架完成！** 可复用Agent框架+5阶段对话流程  
 > - **2026-01-22：OSS 存储集成完成！** 阿里云 OSS 正式接入平台基础层  
-> - **2026-01-21：成功替换 Dify！** PKB 模块完全使用自研 pgvector RAG 引擎  
 >  
 > **最新进展（IIT Manager Agent 2026-02-08）：**  
-> - ✅ **实时质控系统**：pg-boss 防抖 + 质控日志（审计轨迹） + 录入汇总（upsert）  
-> - ✅ **管理端批量操作**：一键全量质控 + 一键全量汇总（前后端完整）  
-> - ✅ **质控优化计划**：XML 临床切片格式 + 质控驾驶舱 + 变量标签系统  
-> - ✅ **双脑架构**：SOP 状态机（结构化任务） + ReAct 引擎（模糊查询）  
-> - ✅ **三层记忆**：流水账（全量日志） + 热记忆（高频注入） + 历史书（按需检索）  
-> - ✅ **隐私合规**：PII 脱敏中间件 + 审计日志 + 可恢复脱敏  
+> - ✅ **事件级质控 V3.1**：每个 record+event 独立质控，不再合并覆盖数据  
+> - ✅ **规则动态过滤**：applicableEvents/applicableForms 配置规则适用范围  
+> - ✅ **质控报告去重**：按 recordId+ruleId 去重，避免多事件重复问题  
+> - ✅ **AI 对话增强**：支持"严重违规有几项"等自然语言查询  
+> - ✅ **质控驾驶舱 UI**：PromptBuilder XML 格式 + 热力图 + 详情抽屉  
+> - ✅ **Bug 修复**：formatPatientData 500 错误 + 记录数统计 + 报告限制移除  
 >  
 > **部署状态：** ✅ 生产环境运行中 | 公网地址：http://8.140.53.236/  
 > **REDCap 状态：** ✅ 生产环境运行中 | 地址：https://redcap.xunzhengyixue.com/  
@@ -62,7 +62,7 @@
 | **PKB** | 个人知识库 | RAG问答、私人文献库 | ⭐⭐⭐ | 🎉 **Dify已替换！自研RAG上线（95%）** | P1 |
 | **ASL** | AI智能文献 | 文献筛选、Meta分析、证据图谱 | ⭐⭐⭐⭐⭐ | 🎉 **智能检索MVP完成（60%）** - DeepSearch集成 | **P0** |
 | **DC** | 数据清洗整理 | ETL + 医学NER（百万行级数据） | ⭐⭐⭐⭐⭐ | ✅ **Tool B完成 + Tool C 99%（异步架构+性能优化-99%+多指标转换+7大功能）** | **P0** |
-| **IIT** | IIT Manager Agent | AI驱动IIT研究助手 - 双脑架构+REDCap集成 | ⭐⭐⭐⭐⭐ | 🎉 **实时质控完成 + UI优化计划制定（设计100%，代码45%）** | **P0** |
+| **IIT** | IIT Manager Agent | AI驱动IIT研究助手 - 双脑架构+REDCap集成 | ⭐⭐⭐⭐⭐ | 🎉 **事件级质控V3.1完成（设计100%，代码60%）** | **P0** |
 | **SSA** | 智能统计分析 | 队列/预测模型/RCT分析 | ⭐⭐⭐⭐⭐ | 📋 规划中 | P2 |
 | **ST** | 统计分析工具 | 100+轻量化统计工具 | ⭐⭐⭐⭐ | 📋 规划中 | P2 |
 | **RVW** | 稿件审查系统 | 方法学评估、审稿流程、Word导出 | ⭐⭐⭐⭐ | ✅ **开发完成（95%）** | P3 |
diff --git a/docs/03-业务模块/IIT Manager Agent/00-模块当前状态与开发指南.md b/docs/03-业务模块/IIT Manager Agent/00-模块当前状态与开发指南.md
index 0648aee4..537e1b4d 100644
--- a/docs/03-业务模块/IIT Manager Agent/00-模块当前状态与开发指南.md	
+++ b/docs/03-业务模块/IIT Manager Agent/00-模块当前状态与开发指南.md	
@@ -1,10 +1,12 @@
 # IIT Manager Agent模块 - 当前状态与开发指南
 
-> **文档版本：** v2.2  
+> **文档版本：** v2.4  
 > **创建日期：** 2026-01-01  
 > **维护者：** IIT Manager开发团队  
-> **最后更新：** 2026-02-08 🎉 **质控系统 UI 与 LLM 格式优化计划制定完成！**  
+> **最后更新：** 2026-02-08 🎉 **事件级质控架构 V3.1 开发完成！**  
 > **重大里程碑：**  
+> - ✅ 2026-02-08：**事件级质控架构 V3.1 完成**（record+event 独立质控 + 规则动态过滤 + 报告去重 + AI对话增强）  
+> - ✅ 2026-02-08：**质控驾驶舱 UI 开发完成**（PromptBuilder XML 格式 + 驾驶舱页面 + 热力图 + 详情抽屉）  
 > - ✅ 2026-02-08：**质控系统优化计划制定**（XML 临床切片格式 + 质控驾驶舱设计 + 方案 A 确认）  
 > - ✅ 2026-02-07：**实时质控系统开发完成**（pg-boss防抖 + 质控日志 + 录入汇总 + 管理端批量操作）  
 > - ✅ 2026-02-05：**V2.9.1 完整开发计划发布**（双脑架构 + 三层记忆 + 主动性增强 + 隐私合规）  
@@ -44,11 +46,11 @@ IIT Manager Agent（研究者发起试验管理助手）是一个基于企业微
   - AI能力：DeepSeek/Qwen + 自研 RAG
 
 ### 当前状态
-- **开发阶段**：🎉 **实时质控系统核心功能开发完成！待端到端测试**
+- **开发阶段**：🎉 **事件级质控架构 V3.1 开发完成！基本测试通过**
 - **整体完成度**：
-  - **基础设施**：85%（REDCap + 企业微信 + AI 对话 + 实时质控）
+  - **基础设施**：95%（REDCap + 企业微信 + AI 对话 + 实时质控 + 驾驶舱 UI + 事件级质控）
   - **架构设计**：100%（V2.9.1 完整开发计划发布）
-  - **代码实现**：45%（实时质控系统已实现）
+  - **代码实现**：60%（实时质控系统 + 驾驶舱 UI + 事件级质控 V3.1 已实现）
 
 #### ✅ 已完成功能（基础设施）
 - ✅ 数据库Schema创建（iit_schema，9个表 = 原5个 + 新增4个质控表）
@@ -77,6 +79,26 @@ IIT Manager Agent（研究者发起试验管理助手）是一个基于企业微
 - ✅ **自动化工具设计**（AutoMapper REDCap Schema 对齐）
 - ✅ **模块化开发文档**（6 份专项文档）
 
+#### ✅ 已完成功能（质控驾驶舱 UI - 2026-02-08）
+- ✅ **PromptBuilder 类**（XML 临床切片格式构建器，减少 LLM 幻觉）
+- ✅ **ChatService 优化**（集成 PromptBuilder，使用 XML 格式化数据）
+- ✅ **质控驾驶舱页面**（IitQcCockpitPage.tsx，全屏展示模式）
+- ✅ **统计卡片组件**（QcStatCards.tsx，4 个核心指标）
+- ✅ **风险热力图组件**（RiskHeatmap.tsx，受试者×表单矩阵视图）
+- ✅ **详情抽屉组件**（QcDetailDrawer.tsx，含 LLM Trace 视图）
+- ✅ **驾驶舱后端 API**（iitQcCockpitService + Controller + Routes）
+- ✅ **前端类型定义**（qcCockpit.ts，完整的 TypeScript 类型）
+
+#### ✅ 已完成功能（事件级质控 V3.1 - 2026-02-08）
+- ✅ **事件级质控架构**（每个 record+event 独立质控，不再合并数据）
+- ✅ **规则动态过滤**（applicableEvents/applicableForms 配置规则适用范围）
+- ✅ **RedcapAdapter 增强**（getAllRecordsByEvent + getFormEventMapping + getEvents）
+- ✅ **SkillRunner 重构**（按 record+event 执行 + filterApplicableRules）
+- ✅ **质控报告去重**（按 recordId+ruleId 去重，避免多事件重复问题）
+- ✅ **报告自动刷新**（导出 XML 前自动获取最新数据）
+- ✅ **AI 意图识别增强**（支持"严重违规有几项"等自然语言查询）
+- ✅ **Bug 修复**（formatPatientData 500 错误 + 记录数统计 + 报告限制移除）
+
 #### ⏳ 待实施功能（按 Phase 规划）
 | Phase | 内容 | 优先级 | 状态 |
 |-------|------|--------|------|
@@ -914,10 +936,11 @@ npx ts-node src/modules/iit-manager/test-wechat-push.ts
 ---
 
 > **提示**：本文档反映IIT Manager Agent模块的最新真实状态，每个里程碑完成后必须更新！  
-> **最后更新**：2026-01-03 22:30  
-> **当前进度**：Day 1-3 + Phase 1.5完成（60%）| 下一步：Phase 2 Function Calling + Dify知识库  
+> **最后更新**：2026-02-08 22:00  
+> **当前进度**：事件级质控 V3.1 完成（60%）| 下一步：Phase 3 ReAct 引擎 + 流水账  
 > **重要文档**：
-> - [Phase 1.5开发完成记录](./06-开发记录/Phase1.5-AI对话集成REDCap完成记录.md) ⭐⭐⭐⭐⭐
+> - [事件级质控开发记录](./06-开发记录/2026-02-08-事件级质控与报告优化开发记录.md) ⭐⭐⭐⭐⭐
+> - [实时质控系统开发记录](./06-开发记录/2026-02-07-实时质控系统开发记录.md) ⭐⭐⭐⭐⭐
 > - [REDCap对接技术方案与实施指南](./04-开发计划/REDCap对接技术方案与实施指南.md) ⭐⭐⭐⭐⭐
 
 
diff --git a/docs/03-业务模块/IIT Manager Agent/02-技术设计/CRA Agent 业务逻辑与执行架构书 (1).md b/docs/03-业务模块/IIT Manager Agent/02-技术设计/CRA Agent 业务逻辑与执行架构书 (1).md
new file mode 100644
index 00000000..d8516dc4
--- /dev/null
+++ b/docs/03-业务模块/IIT Manager Agent/02-技术设计/CRA Agent 业务逻辑与执行架构书 (1).md	
@@ -0,0 +1,72 @@
+# **CRA Agent 业务逻辑与执行架构书**
+
+**文档目的：** 基于用户定义的 5 大规则体系，构建标准化的 CRA 智能监查工作流。
+
+**适用版本：** IIT Manager Agent V2.9.1
+
+**创建日期：** 2026-02-07
+
+## **🏛️ 一、 规则体系定义 (The 5 Pillars)**
+
+我们将规则分为两类引擎执行，以平衡成本与智能。
+
+| 编号 | 规则类型 | 执行引擎 | 来源方式 | 典型示例 |
+| :---- | :---- | :---- | :---- | :---- |
+| **1** | **变量质控** | **Hard Engine** (代码) | 自动从 Metadata 同步 | 空值检查、数值范围 (0\<BMI\<50)、逻辑跳转 |
+| **2** | **入排标准** | **AI Engine** (LLM) | AI 解析 Protocol \+ 人工确认 | 确诊时间 \< 3个月、实验室指标符合入组线 |
+| **3** | **方案偏离 (PD)** | **Hybrid** (混合) | 人工配置逻辑 | 访视超窗 (Date2 \- Date1 \> 28+3)、禁用药物使用 |
+| **4** | **AE 事件** | **AI Engine** (LLM) | 预置医学 Prompt | Lab 异常值 vs AE 记录一致性检查 (SAE Reconciliation) |
+| **5** | **伦理合规** | **Hard Engine** (代码) | 预置逻辑 | 知情同意书签署日期 \> 访视 1 日期 |
+
+## **🔄 二、 智能监查工作流 (The Workflow)**
+
+### **Step 1: 触发与范围界定 (Trigger)**
+
+* **触发源**：  
+  * **自动触发**：Webhook (REDCap 数据录入) 或 Cron (每日凌晨)。  
+  * **人工触发**：用户点击“立即监查”。  
+* **范围优化**：使用 **增量检查 (Incremental Check)**。只对新录入或变更的数据及其相关联规则进行检查。
+
+### **Step 2: 漏斗式质控执行 (Funnel Execution)**
+
+为每个受试者执行以下管道：
+
+1. **Level 1: 阻断性检查 (Blocking)**  
+   * 检查伦理 (ICF) 和 关键变量缺失。  
+   * *如果 Fail*：直接标记为 Critical，**中止后续 AI 检查**（省钱）。  
+2. **Level 2: 基础清洗 (Cleaning)**  
+   * 运行所有变量质控规则 (Hard Rules)。  
+   * 生成基础错误日志。  
+3. **Level 3: AI 深度监查 (AI Reasoning)**  
+   * 组装 Context (XML+Markdown)。  
+   * 调用 LLM 检查 入排、PD、AE。  
+   * **输出证据链**：{ "status": "FAIL", "reason": "...", "evidence": { "var": "alt", "val": 150 } }
+
+### **Step 3: 结果汇总 (Aggregation)**
+
+更新 iit\_qc\_project\_stats 和 iit\_record\_summary 表。
+
+* 生成 **风险热力图 (Risk Heatmap)** 数据源。
+
+### **Step 4: 双模报告输出 (Dual-Mode Reporting)**
+
+* **Mode A: 人类阅读版 (Interactive UI)**  
+  * 热力图 \+ 诊断卡片。  
+  * 支持 **“确认/忽略”** 操作 (Query Loop)。  
+* **Mode B: LLM 阅读版 (Context Protocol)**  
+  * XML 结构化数据，包含统计摘要 \+ 严重问题清单 \+ 证据链。
+
+### **Step 5: 智能问答 (Q\&A Loop)**
+
+* 用户提问 \-\> ContextBuilder 提取 Mode B 报告 \-\> LLM 回答。  
+* *场景*：“帮我列出所有疑似未报 AE 的患者。”
+
+## **💡 三、 关键增强点**
+
+1. **SDV 边界声明**：明确系统仅进行“逻辑一致性监查”，无法核对原始病历真伪。  
+2. **人机回环 (HITL)**：所有 AI 生成的复杂规则（入排/PD），必须经过人工 **"Review & Activate"** 才能生效。  
+3. **三态管理**：质控结果包含 Pending (AI 疑似), Confirmed (人工确认), Ignored (人工忽略)。
+
+## **✅ 结论**
+
+该方案逻辑闭环，技术可行。通过引入 **漏斗执行** 和 **人机回环**，可有效解决成本与准确性问题。
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/02-技术设计/docs_03-业务模块_IIT Manager Agent_02-技术设计_11-基于Skills的CRA规则配置实施指南.md b/docs/03-业务模块/IIT Manager Agent/02-技术设计/docs_03-业务模块_IIT Manager Agent_02-技术设计_11-基于Skills的CRA规则配置实施指南.md
new file mode 100644
index 00000000..421b0f82
--- /dev/null
+++ b/docs/03-业务模块/IIT Manager Agent/02-技术设计/docs_03-业务模块_IIT Manager Agent_02-技术设计_11-基于Skills的CRA规则配置实施指南.md	
@@ -0,0 +1,200 @@
+# **基于 Skills 的 CRA 规则配置实施指南**
+
+**文档目的：** 定义如何通过 iit\_skills 表配置化实现 CRA 的 5 大核心工作（变量质控、入排、PD、AE、伦理）。
+
+**适用版本：** IIT Manager Agent V2.9.1
+
+**创建日期：** 2026-02-07
+
+## **🏗️ 核心概念：Skill \= 规则容器**
+
+在我们的架构中，**Skill (技能)** 是一个可执行的最小业务单元。它定义了：
+
+1. **触发条件**：什么时候跑？(Webhook/Cron)  
+2. **执行引擎**：用哪个引擎跑？(Hard/Soft)  
+3. **配置数据**：具体规则是什么？(JSON/Prompt)  
+4. **数据依赖**：需要哪些数据？(Tags)
+
+### **数据库模型映射 (iit\_skills)**
+
+我们复用并扩展 V2.6 计划中的 iit\_skills 表设计：
+
+model IitSkill {  
+  id          String   @id @default(uuid())  
+  projectId   String   @map("project\_id")  
+  name        String   // e.g., "入排标准核查"  
+  type        String   // 'HARD\_RULE' | 'LLM\_CHECK' | 'HYBRID'  
+    
+  // 触发配置  
+  triggerType String   @map("trigger\_type") // 'WEBHOOK' | 'CRON' | 'MANUAL'  
+  cronExpr    String?  @map("cron\_expr")    // 如果是定时任务  
+    
+  // 核心配置 (JSONB)  
+  // 包含：Prompts, JSONLogic, Thresholds  
+  config      Json  
+    
+  // 数据依赖 (智能路由用)  
+  // 告诉 ContextBuilder 需要加载哪些 Tag  
+  requiredTags String\[\] @map("required\_tags") // e.g., \['\#lab', '\#demographics'\]
+
+  isEnabled   Boolean  @default(true)  
+  createdAt   DateTime @default(now())  
+    
+  @@map("iit\_skills")  
+  @@schema("iit\_schema")  
+}
+
+## **🛠️ 五大规则的 Skill 实现方案**
+
+我们通过配置不同类型的 Skill 来覆盖 CRA 的所有工作。
+
+### **1\. 变量质控 Skill (Type: HARD\_RULE)**
+
+**对应需求：** 针对每个变量，构建数据质控规则。
+
+* **场景**：空值检查、数值范围、逻辑跳转。  
+* **配置来源**：Rule Studio (Layer 1\) 自动生成。  
+* **Config 结构**：  
+  {  
+    "engine": "HardRuleEngine",  
+    "rules": \[  
+      { "field": "age", "op": "between", "args": \[18, 80\] },  
+      { "field": "bmi", "op": "lt", "args": \[50\] }  
+    \]  
+  }
+
+* **执行**：Node.js 直接计算，毫秒级响应。
+
+### **2\. 入排标准 Skill (Type: LLM\_CHECK)**
+
+**对应需求：** 针对是否符合入排标准，建立医学逻辑规则。
+
+* **场景**：复杂的医学判断（如：病理确诊时间 \< 3个月）。  
+* **配置来源**：Rule Studio (Layer 3\) AI 提取 \+ 人工确认。  
+* **数据依赖**：\['\#demographics', '\#lab', '\#history'\]  
+* **Config 结构**：  
+  {  
+    "engine": "SoftRuleEngine",  
+    "model": "deepseek-v3",  
+    "system\_prompt": "你是一个医学监查员...",  
+    "checks": \[  
+      {  
+        "id": "I-03",  
+        "desc": "肝肾功能正常 (ALT/AST \< 2.5 ULN)",  
+        "prompt\_template": "基于以下实验室数据 {{\#lab}}，判断..."  
+      }  
+    \]  
+  }
+
+### **3\. 方案偏离 Skill (Type: HYBRID)**
+
+**对应需求：** 针对是否出现方案偏离，建立核查规则。
+
+* **场景**：访视超窗、漏做检查。  
+* **配置来源**：Rule Studio (Layer 2\) 逻辑构建器。  
+* **Config 结构**：  
+  {  
+    "engine": "HybridEngine",  
+    "logic": {  
+      "if": \[  
+        { "date\_diff": \["$V2.date", "$V1.date"\] },  
+        { "\>": 31 }, // 28 \+ 3  
+        "FAIL",  
+        "PASS"  
+      \]  
+    }  
+  }
+
+### **4\. AE 监测 Skill (Type: LLM\_CHECK)**
+
+**对应需求：** 针对是否出现 AE 事件，建立核查规则。
+
+* **场景**：SAE Reconciliation（Lab 异常 vs AE 记录）。  
+* **数据依赖**：\['\#lab', '\#ae'\]  
+* **Config 结构**：  
+  {  
+    "engine": "SoftRuleEngine",  
+    "task": "AE\_RECONCILIATION",  
+    "prompt": "对比 \<lab\_data\> 中的 Grade 3+ 异常值与 \<ae\_data\> 记录，找出未报告的 AE。"  
+  }
+
+### **5\. 伦理合规 Skill (Type: HARD\_RULE)**
+
+**对应需求：** 针对是否出现伦理问题，建立规则。
+
+* **场景**：ICF 日期逻辑。  
+* **Config 结构**：  
+  {  
+    "engine": "HardRuleEngine",  
+    "rule": {  
+      "op": "date\_before",  
+      "a": "$icf\_date",  
+      "b": "$first\_visit\_date"  
+    },  
+    "severity": "CRITICAL"  
+  }
+
+## **⏰ 三大触发时机详解 (Trigger Strategy)**
+
+我们将质控规则的执行时机划分为“实时、定时、人工”黄金三角，以平衡时效性与成本。
+
+### **1\. 🟢 实时触发 (Real-time / Webhook)**
+
+* **触发源**：REDCap DET (Data Entry Trigger)。CRC 保存任意表单时触发。  
+* **执行范围**：**单点切片 (Micro-Batch)**。  
+  * 仅针对 **当前受试者 (Current Record)**。  
+  * 仅加载 **与当前表单相关** 的 Skill (通过 formName 过滤)。  
+  * *例如：录入“血常规”单，系统只检查 \#lab 相关规则，不会检查人口学。*  
+* **核心价值**：**阻断错误**。在 CRC 记忆犹新时（秒级）推送企微提醒，纠正成本最低。  
+* **成本策略**：默认优先跑 **Hard Rules**。涉及核心安全指标（如 AE）时才触发 Soft Rules (LLM)。
+
+### **2\. 🔵 定时触发 (Scheduled / Cron)**
+
+* **触发源**：pg-boss Cron Job。每日凌晨 (e.g., 02:00) 执行。  
+* **执行范围**：**全量扫描 (Full Scan)**。  
+  * 针对 **所有活跃受试者**。  
+  * 重点运行 **跨表逻辑** (如一致性检查) 和 **时间敏感型规则** (如访视超窗 PD)。  
+* **核心价值**：**发现隐患**。捕捉“因时间流逝而产生的问题”（如昨天未超窗，今天超窗）和“漏录问题”。  
+* **成本策略**：使用 **增量标记**。若数据 Hash 未变且无时间规则，跳过 LLM 检查。
+
+### **3\. 🟠 人工触发 (Manual / On-Demand)**
+
+* **触发源**：管理端 "一键全量质控" 或 "单受试者重跑" 按钮。  
+* **执行范围**：**按需全量**。  
+  * 针对选定的受试者范围。  
+  * 运行 **所有启用** 的 Skill。  
+* **核心价值**：**合规审计与验证**。用于项目初始化清洗、规则调整后的验证、或上级核查前的自查。
+
+## **🔄 调度与执行：Skill Runner**
+
+我们不需要为每个规则写死代码，而是实现一个通用的 **SkillRunner**。
+
+### **执行流程**
+
+1. **触发 (Trigger)**：  
+   * Webhook 收到数据 \-\> 触发 SkillRunner.runByTrigger('WEBHOOK', projectId, recordId, formName)  
+   * Cron Job 到点 \-\> 触发 SkillRunner.runByTrigger('CRON', projectId)  
+   * 人工点击 \-\> 触发 SkillRunner.runByTrigger('MANUAL', projectId)  
+2. **加载 (Load)**：  
+   * Runner 从 iit\_skills 表加载所有启用的 Skill。  
+   * **过滤**：如果是 WEBHOOK 触发，仅加载与当前 formName 关联的 Skill。  
+3. **路由 (Route)**：  
+   * 根据 Skill 的 type 分发给对应的 Engine (HardRuleEngine 或 SoftRuleEngine)。  
+4. **上下文构建 (Context)**：  
+   * 如果需要 LLM，调用 ContextBuilder，传入 Skill 定义的 requiredTags，只拉取相关数据。  
+5. **结果聚合 (Aggregate)**：  
+   * 收集所有 Skill 的执行结果，存入 iit\_qc\_logs。
+
+## **✅ 结论：对当前计划的影响**
+
+你的 **V2.6 开发计划** 非常稳健，只需要在细节上明确 Skill 的定义即可。
+
+**建议调整：**
+
+1. **Phase 1**：重点设计 iit\_skills 的 JSON Schema，确保它能容纳上述 5 种类型的配置。  
+2. **Phase 2**：实现 SkillRunner，作为连接 SOP 和 Engine 的中间件。
+
+**总结**：通过 SKILLS 配置化，你的系统就像一个\*\*“可插拔的乐高玩具”\*\*。
+
+* 如果明天要加一个“肿瘤评估 (RECIST)”规则，你只需要新增一个 Skill，完全不用改后端代码。  
+* 这正是 SaaS 化产品的核心竞争力。
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/04-开发计划/07-质控系统UI与LLM格式优化计划.md b/docs/03-业务模块/IIT Manager Agent/04-开发计划/07-质控系统UI与LLM格式优化计划.md
index ead04c31..201b1d4a 100644
--- a/docs/03-业务模块/IIT Manager Agent/04-开发计划/07-质控系统UI与LLM格式优化计划.md	
+++ b/docs/03-业务模块/IIT Manager Agent/04-开发计划/07-质控系统UI与LLM格式优化计划.md	
@@ -338,18 +338,33 @@ WHERE field_name = 'informed_consent';
 
 ## 六、验收标准
 
-### 6.1 阶段 1 验收
+### 6.1 阶段 1 验收 ✅ **已完成 (2026-02-08)**
 
-- [ ] 企业微信问"质控情况"，AI 回答格式清晰、无幻觉
-- [ ] AI 回答包含具体问题和记录数
-- [ ] 日志中可看到 XML 格式的 Prompt
+- [x] 企业微信问"质控情况"，AI 回答格式清晰、无幻觉
+- [x] AI 回答包含具体问题和记录数
+- [x] 日志中可看到 XML 格式的 Prompt
 
-### 6.2 阶段 2 验收
+**完成的文件：**
+- `backend/src/modules/iit-manager/services/PromptBuilder.ts` - XML 临床切片格式构建器
+- `backend/src/modules/iit-manager/services/ChatService.ts` - 集成 PromptBuilder，优化 LLM 格式
 
-- [ ] 点击"质控全览图"按钮可进入驾驶舱页面
-- [ ] 统计卡片正确显示质量分、违规数、完成率
-- [ ] 热力图正确显示记录×表单的质控状态
-- [ ] 点击红色单元格可查看问题详情
+### 6.2 阶段 2 验收 ✅ **已完成 (2026-02-08)**
+
+- [x] 点击"质控全览图"按钮可进入驾驶舱页面
+- [x] 统计卡片正确显示质量分、违规数、完成率
+- [x] 热力图正确显示记录×表单的质控状态
+- [x] 点击红色单元格可查看问题详情
+
+**完成的文件：**
+- `frontend-v2/src/modules/admin/pages/IitQcCockpitPage.tsx` - 驾驶舱主页面
+- `frontend-v2/src/modules/admin/pages/IitQcCockpitPage.css` - 驾驶舱样式
+- `frontend-v2/src/modules/admin/components/qc-cockpit/QcStatCards.tsx` - 统计卡片组件
+- `frontend-v2/src/modules/admin/components/qc-cockpit/RiskHeatmap.tsx` - 风险热力图组件
+- `frontend-v2/src/modules/admin/components/qc-cockpit/QcDetailDrawer.tsx` - 详情抽屉组件
+- `frontend-v2/src/modules/admin/types/qcCockpit.ts` - 类型定义
+- `backend/src/modules/admin/iit-projects/iitQcCockpitService.ts` - 驾驶舱数据服务
+- `backend/src/modules/admin/iit-projects/iitQcCockpitController.ts` - 驾驶舱 API 控制器
+- `backend/src/modules/admin/iit-projects/iitQcCockpitRoutes.ts` - 驾驶舱路由
 
 ### 6.3 阶段 3 验收
 
diff --git a/docs/03-业务模块/IIT Manager Agent/04-开发计划/08-CRA智能质控引擎开发计划.md b/docs/03-业务模块/IIT Manager Agent/04-开发计划/08-CRA智能质控引擎开发计划.md
new file mode 100644
index 00000000..e48bf109
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+++ b/docs/03-业务模块/IIT Manager Agent/04-开发计划/08-CRA智能质控引擎开发计划.md	
@@ -0,0 +1,583 @@
+# CRA 智能质控引擎开发计划
+
+> **版本：** V1.0  
+> **日期：** 2026-02-08  
+> **基于：** V2.6 综合开发计划、CRA Agent 业务逻辑与执行架构书、Skills 配置实施指南  
+> **核心目标：** 实现基于规则的智能质控引擎 + 报告驱动的 LLM 问答
+
+---
+
+## 📋 目录
+
+1. [背景与目标](#1-背景与目标)
+2. [架构设计](#2-架构设计)
+3. [五大规则体系](#3-五大规则体系)
+4. [当前代码现状](#4-当前代码现状)
+5. [开发任务清单](#5-开发任务清单)
+6. [数据库设计补充](#6-数据库设计补充)
+7. [验收标准](#7-验收标准)
+
+---
+
+## 1. 背景与目标
+
+### 1.1 业务需求
+
+针对 CRA（临床研究助理）的质控工作，基于 REDCap 系统的数据结构，建立以下规则体系：
+
+| 编号 | 规则类型 | 说明 | 来源 |
+|------|----------|------|------|
+| 1 | 变量质控 | 针对每个变量的数据校验（空值、范围、格式） | 自动从 Metadata 同步 |
+| 2 | 入排标准 | 判断是否符合入组/排除标准 | AI 解析 Protocol + 人工确认 |
+| 3 | 方案偏离 (PD) | 检测访视超窗、漏做检查等 | 人工配置逻辑 |
+| 4 | AE 事件 | 检测未报告的不良事件 | 预置医学 Prompt |
+| 5 | 伦理合规 | ICF 签署时间、隐私保护等 | 预置硬规则 |
+
+### 1.2 核心目标
+
+```
+┌─────────────────────────────────────────────────────────────────┐
+│  🎯 目标：报告驱动的智能质控                                      │
+│                                                                 │
+│  后台预计算 → 生成结构化报告 → LLM 阅读报告 → 回答用户问题         │
+│                                                                 │
+│  ✅ 快速（报告已预生成）                                          │
+│  ✅ 全面（后台执行所有规则）                                       │
+│  ✅ 省钱（LLM 只做阅读理解）                                       │
+└─────────────────────────────────────────────────────────────────┘
+```
+
+### 1.3 与 V2.6 计划的关系
+
+本计划是 V2.6 综合开发计划的**专项实施细化**，聚焦于：
+- Phase 1 的 `HardRuleEngine` 深化
+- Phase 2 的 `SoftRuleEngine` 实现
+- Phase 4 的 `SchedulerService` 和 `ReportService` 实现
+
+---
+
+## 2. 架构设计
+
+### 2.1 整体架构
+
+```
+┌─────────────────────────────────────────────────────────────────┐
+│                        触发层 (Trigger)                          │
+├──────────────────┬──────────────────┬───────────────────────────┤
+│  🟢 Webhook       │  🔵 Cron          │  🟠 Manual                 │
+│  REDCap DET      │  每日凌晨         │  一键全量质控              │
+│  单记录实时       │  全量扫描         │  按需执行                  │
+└──────────────────┴──────────────────┴───────────────────────────┘
+                            │
+                            ▼
+┌─────────────────────────────────────────────────────────────────┐
+│                    🎯 SkillRunner (调度器)                        │
+│                                                                 │
+│  1. 加载启用的 Skills                                            │
+│  2. 根据 triggerType 过滤                                        │
+│  3. 路由到对应 Engine                                            │
+│  4. 聚合结果                                                     │
+└─────────────────────────────────────────────────────────────────┘
+                            │
+          ┌─────────────────┼─────────────────┐
+          ▼                 ▼                 ▼
+┌──────────────────┐ ┌──────────────────┐ ┌──────────────────┐
+│  HardRuleEngine  │ │  SoftRuleEngine  │ │  HybridEngine    │
+│  (已实现 ✅)      │ │  (待实现 ❌)      │ │  (待实现 ❌)     │
+│                  │ │                  │ │                  │
+│  - 变量质控      │ │  - 入排标准      │ │  - 方案偏离      │
+│  - 伦理合规      │ │  - AE 检测       │ │  - Hard + Soft   │
+│                  │ │                  │ │                  │
+│  JSON Logic      │ │  LLM 推理        │ │  条件分支        │
+└──────────────────┘ └──────────────────┘ └──────────────────┘
+                            │
+                            ▼
+┌─────────────────────────────────────────────────────────────────┐
+│                    📊 结果存储 & 报告生成                          │
+├─────────────────────────────────────────────────────────────────┤
+│  iit_qc_logs          → 详细质控日志                              │
+│  iit_qc_project_stats → 项目统计摘要                              │
+│  iit_qc_report (新)   → LLM 友好的结构化报告                      │
+└─────────────────────────────────────────────────────────────────┘
+                            │
+                            ▼
+┌─────────────────────────────────────────────────────────────────┐
+│                    💬 用户问答 (实时)                              │
+│                                                                 │
+│  用户提问 → ContextBuilder 加载报告 → LLM 阅读 → 回答             │
+└─────────────────────────────────────────────────────────────────┘
+```
+
+### 2.2 漏斗式执行策略
+
+为每个受试者执行以下管道，**分级检查，逐层深入**：
+
+```
+┌─────────────────────────────────────────────────────────────────┐
+│  Level 1: 阻断性检查 (Blocking)                                  │
+│  - 伦理合规 (ICF 日期)                                           │
+│  - 关键字段缺失                                                  │
+│  如果 FAIL → 直接标记 Critical，跳过后续 AI 检查（省钱）           │
+├─────────────────────────────────────────────────────────────────┤
+│  Level 2: 基础清洗 (Hard Rules)                                  │
+│  - 所有变量质控规则                                               │
+│  - 生成基础错误日志                                               │
+├─────────────────────────────────────────────────────────────────┤
+│  Level 3: AI 深度监查 (Soft Rules)                               │
+│  - 入排标准判断                                                  │
+│  - 方案偏离检测                                                  │
+│  - AE 事件核查                                                   │
+│  - 输出证据链                                                    │
+└─────────────────────────────────────────────────────────────────┘
+```
+
+---
+
+## 3. 五大规则体系
+
+### 3.1 规则类型与执行引擎
+
+| 编号 | 规则类型 | 执行引擎 | 触发时机 | 典型示例 |
+|------|----------|----------|----------|----------|
+| 1 | 变量质控 | HardRuleEngine | 实时 + 定时 | 空值检查、0 < BMI < 50 |
+| 2 | 入排标准 | SoftRuleEngine | 定时 + 人工 | 确诊时间 < 3个月 |
+| 3 | 方案偏离 | HybridEngine | 定时 | 访视超窗 (Date2 - Date1 > 28+3) |
+| 4 | AE 事件 | SoftRuleEngine | 定时 | Lab 异常 vs AE 记录一致性 |
+| 5 | 伦理合规 | HardRuleEngine | 实时 | ICF 签署日期 > 首次访视 |
+
+### 3.2 Skill 配置示例
+
+#### 3.2.1 变量质控 Skill (HARD_RULE)
+
+```json
+{
+  "skillType": "VARIABLE_QC",
+  "name": "变量质控",
+  "type": "HARD_RULE",
+  "triggerType": "webhook",
+  "config": {
+    "engine": "HardRuleEngine",
+    "rules": [
+      {
+        "id": "VQ-001",
+        "name": "年龄范围检查",
+        "field": "age",
+        "formName": "demographics",
+        "logic": { "and": [{ ">=": [{ "var": "age" }, 18] }, { "<=": [{ "var": "age" }, 80] }] },
+        "message": "年龄必须在 18-80 岁之间",
+        "severity": "error",
+        "category": "lab_values"
+      },
+      {
+        "id": "VQ-002",
+        "name": "BMI 范围检查",
+        "field": "bmi",
+        "formName": "demographics",
+        "logic": { "and": [{ ">": [{ "var": "bmi" }, 0] }, { "<": [{ "var": "bmi" }, 50] }] },
+        "message": "BMI 值异常",
+        "severity": "warning",
+        "category": "lab_values"
+      }
+    ]
+  }
+}
+```
+
+#### 3.2.2 入排标准 Skill (LLM_CHECK)
+
+```json
+{
+  "skillType": "INCLUSION_EXCLUSION",
+  "name": "入排标准核查",
+  "type": "LLM_CHECK",
+  "triggerType": "cron",
+  "config": {
+    "engine": "SoftRuleEngine",
+    "model": "deepseek-v3",
+    "systemPrompt": "你是一个专业的临床研究监查员，负责核查受试者是否符合入组标准。",
+    "checks": [
+      {
+        "id": "IE-001",
+        "name": "确诊时间核查",
+        "promptTemplate": "基于以下数据，判断受试者的确诊时间是否在 3 个月内：\n{{#demographics}}\n{{#medical_history}}\n\n请给出判断结果 (PASS/FAIL) 和理由。",
+        "requiredTags": ["#demographics", "#medical_history"]
+      }
+    ]
+  },
+  "requiredTags": ["#demographics", "#medical_history", "#lab"]
+}
+```
+
+#### 3.2.3 伦理合规 Skill (HARD_RULE)
+
+```json
+{
+  "skillType": "ETHICS_COMPLIANCE",
+  "name": "伦理合规检查",
+  "type": "HARD_RULE",
+  "triggerType": "webhook",
+  "config": {
+    "engine": "HardRuleEngine",
+    "level": "blocking",
+    "rules": [
+      {
+        "id": "EC-001",
+        "name": "知情同意书签署时间",
+        "field": ["icf_date", "first_visit_date"],
+        "logic": { "<=": [{ "var": "icf_date" }, { "var": "first_visit_date" }] },
+        "message": "知情同意书签署日期必须早于或等于首次访视日期",
+        "severity": "error",
+        "category": "ethics"
+      }
+    ]
+  }
+}
+```
+
+---
+
+## 4. 当前代码现状
+
+### 4.1 已实现组件 ✅
+
+| 组件 | 路径 | 说明 |
+|------|------|------|
+| `IitSkill` 表 | `prisma/schema.prisma` | 已定义，支持 triggerType |
+| `IitFieldMapping` 表 | `prisma/schema.prisma` | 字段映射表 |
+| `HardRuleEngine` | `engines/HardRuleEngine.ts` | 基于 JSON Logic，支持 formName 过滤 |
+| `QcService` | `services/QcService.ts` | 基础查询服务 |
+| `PromptBuilder` | `services/PromptBuilder.ts` | XML Clinical Slice 格式 |
+| `RedcapAdapter` | `adapters/RedcapAdapter.ts` | REDCap API 适配 |
+| QC Cockpit UI | `frontend-v2/.../IitQcCockpitPage.tsx` | 热力图 + 详情抽屉 |
+| 字段元数据同步 | `iitProjectService.syncMetadata` | 含 Form Labels |
+
+### 4.2 缺失组件 ❌
+
+| 组件 | 优先级 | 依赖 | 说明 |
+|------|--------|------|------|
+| `SoftRuleEngine` | P0 | LLMFactory | LLM 推理引擎 |
+| `HybridEngine` | P1 | HardRule + SoftRule | 混合执行引擎 |
+| `SkillRunner` | P0 | 所有 Engine | 规则调度器 |
+| `QcReportService` | P0 | SkillRunner | LLM 友好报告生成 |
+| `iit_qc_report` 表 | P0 | - | 报告存储 |
+| 定时调度 | P1 | pg-boss / node-cron | Cron 触发 |
+| 增量检查 | P2 | - | 数据 Hash 策略 |
+| Rule Studio UI | P2 | - | 规则配置界面 |
+| 默认规则配置 | P0 | - | 5 大规则的初始 JSON |
+
+---
+
+## 5. 开发任务清单
+
+### Phase 1: 核心引擎 (Week 1)
+
+| 任务 | 优先级 | 预估 | 产出 |
+|------|--------|------|------|
+| 1.1 实现 `SoftRuleEngine` | P0 | 2天 | LLM 推理引擎 |
+| 1.2 实现 `SkillRunner` | P0 | 1天 | 规则调度器 |
+| 1.3 扩展 `IitSkill` Schema | P0 | 0.5天 | 添加 `requiredTags` 字段 |
+| 1.4 创建默认规则配置 | P0 | 1天 | 5 大规则的 Seed 数据 |
+
+#### 1.1 SoftRuleEngine 设计
+
+```typescript
+// backend/src/modules/iit-manager/engines/SoftRuleEngine.ts
+
+export interface SoftRuleCheck {
+  id: string;
+  name: string;
+  promptTemplate: string;
+  requiredTags: string[];
+}
+
+export interface SoftRuleResult {
+  checkId: string;
+  status: 'PASS' | 'FAIL' | 'UNCERTAIN';
+  reason: string;
+  evidence: Record<string, any>;
+  confidence: number;
+}
+
+export class SoftRuleEngine {
+  private projectId: string;
+  private llmClient: LLMClient;
+  
+  async execute(
+    recordId: string, 
+    data: Record<string, any>,
+    checks: SoftRuleCheck[]
+  ): Promise<SoftRuleResult[]>;
+}
+```
+
+#### 1.2 SkillRunner 设计
+
+```typescript
+// backend/src/modules/iit-manager/engines/SkillRunner.ts
+
+export class SkillRunner {
+  /**
+   * 按触发类型执行 Skills
+   */
+  async runByTrigger(
+    triggerType: 'webhook' | 'cron' | 'manual',
+    projectId: string,
+    options?: {
+      recordId?: string;      // webhook 时必传
+      formName?: string;      // webhook 时过滤相关规则
+    }
+  ): Promise<SkillRunResult>;
+  
+  /**
+   * 执行单个 Skill
+   */
+  private async executeSkill(
+    skill: IitSkill,
+    recordId: string,
+    data: Record<string, any>
+  ): Promise<SkillResult>;
+}
+```
+
+### Phase 2: 报告系统 (Week 2)
+
+| 任务 | 优先级 | 预估 | 产出 |
+|------|--------|------|------|
+| 2.1 设计 `iit_qc_report` 表 | P0 | 0.5天 | 报告存储 Schema |
+| 2.2 实现 `QcReportService` | P0 | 2天 | 报告生成服务 |
+| 2.3 集成到 Cockpit UI | P1 | 1天 | 报告查看入口 |
+| 2.4 实现 LLM 问答集成 | P1 | 1天 | 基于报告回答 |
+
+#### 2.2 QcReportService 设计
+
+```typescript
+// backend/src/modules/iit-manager/services/QcReportService.ts
+
+export interface QcReport {
+  projectId: string;
+  generatedAt: Date;
+  summary: {
+    totalRecords: number;
+    criticalIssues: number;
+    pendingQueries: number;
+    passRate: number;
+  };
+  criticalList: QcIssue[];
+  warningList: QcIssue[];
+  llmFriendlyXml: string;  // LLM 阅读版
+}
+
+export class QcReportService {
+  /**
+   * 生成项目质控报告
+   */
+  async generateReport(projectId: string): Promise<QcReport>;
+  
+  /**
+   * 获取缓存的报告（用于 LLM 问答）
+   */
+  async getCachedReport(projectId: string): Promise<string>;
+  
+  /**
+   * 构建 LLM 友好的 XML 报告
+   */
+  private buildLlmXmlReport(stats: ProjectStats, issues: QcIssue[]): string;
+}
+```
+
+#### LLM 阅读版报告格式
+
+```xml
+<qc_report project="PD-001" generated="2026-02-08T10:00:00Z">
+  <summary>
+    <total_records>50</total_records>
+    <critical_issues>3</critical_issues>
+    <pending_queries>12</pending_queries>
+    <pass_rate>85.2%</pass_rate>
+  </summary>
+  
+  <critical_list>
+    <issue record="P001" rule="EC-001" severity="RED">
+      <description>知情同意书签署日期(2026-01-15)晚于首次访视(2026-01-10)</description>
+      <evidence>
+        <field name="icf_date">2026-01-15</field>
+        <field name="first_visit_date">2026-01-10</field>
+      </evidence>
+    </issue>
+    <issue record="P003" rule="IE-001" severity="RED">
+      <description>受试者确诊时间超过入组标准（确诊日期距入组已超过3个月）</description>
+      <evidence>
+        <field name="diagnosis_date">2025-10-01</field>
+        <field name="enrollment_date">2026-02-01</field>
+      </evidence>
+    </issue>
+  </critical_list>
+  
+  <warning_list>
+    <issue record="P007" rule="VQ-002" severity="YELLOW">
+      <description>BMI 值偏高(42.5)，请核实</description>
+    </issue>
+  </warning_list>
+  
+  <by_form>
+    <form name="人口学" total="50" pass="48" fail="2" />
+    <form name="实验室检查" total="150" pass="142" fail="8" />
+  </by_form>
+</qc_report>
+```
+
+### Phase 3: 定时调度 (Week 3)
+
+| 任务 | 优先级 | 预估 | 产出 |
+|------|--------|------|------|
+| 3.1 集成 node-cron | P1 | 0.5天 | 定时任务框架 |
+| 3.2 实现 Cron 触发逻辑 | P1 | 1天 | 定时全量质控 |
+| 3.3 实现增量检查 | P2 | 1天 | 数据 Hash 跳过 |
+| 3.4 实现 Webhook 触发 | P2 | 1天 | REDCap DET 集成 |
+
+### Phase 4: 规则配置 UI (Week 4)
+
+| 任务 | 优先级 | 预估 | 产出 |
+|------|--------|------|------|
+| 4.1 Rule Studio 页面框架 | P2 | 1天 | 规则列表 + 详情 |
+| 4.2 规则编辑器 | P2 | 2天 | JSON 可视化编辑 |
+| 4.3 规则测试功能 | P2 | 1天 | 单条规则验证 |
+
+---
+
+## 6. 数据库设计补充
+
+### 6.1 扩展 IitSkill 表
+
+```prisma
+model IitSkill {
+  id           String   @id @default(uuid())
+  projectId    String   @map("project_id")
+  skillType    String   @map("skill_type")
+  name         String
+  description  String?
+  
+  // 规则类型
+  ruleType     String   @default("HARD_RULE") @map("rule_type")  // 'HARD_RULE' | 'LLM_CHECK' | 'HYBRID'
+  
+  // 执行级别
+  level        String   @default("normal")  // 'blocking' | 'normal'
+  
+  // 核心配置
+  config       Json     @db.JsonB
+  
+  // 数据依赖（智能路由用）
+  requiredTags String[] @map("required_tags")  // 新增：e.g., ['#lab', '#demographics']
+  
+  // 触发配置
+  triggerType  String   @default("webhook") @map("trigger_type")
+  cronSchedule String?  @map("cron_schedule")
+  
+  isActive     Boolean  @default(true) @map("is_active")
+  priority     Int      @default(100)  // 新增：执行优先级
+  
+  createdAt    DateTime @default(now()) @map("created_at")
+  updatedAt    DateTime @updatedAt @map("updated_at")
+
+  @@unique([projectId, skillType], map: "unique_iit_skill_project_type")
+  @@index([projectId], map: "idx_iit_skill_project")
+  @@index([isActive, triggerType], map: "idx_iit_skill_active_trigger")
+  @@map("skills")
+  @@schema("iit_schema")
+}
+```
+
+### 6.2 新增 IitQcReport 表
+
+```prisma
+/// 质控报告存储表 - 存储预生成的 LLM 友好报告
+model IitQcReport {
+  id           String   @id @default(uuid())
+  projectId    String   @map("project_id")
+  
+  // 报告类型
+  reportType   String   @default("daily") @map("report_type")  // 'daily' | 'weekly' | 'on_demand'
+  
+  // 统计摘要
+  summary      Json     @db.JsonB  // { totalRecords, criticalIssues, pendingQueries, passRate }
+  
+  // 详细问题列表
+  issues       Json     @db.JsonB  // [{ record, rule, severity, description, evidence }]
+  
+  // LLM 友好的 XML 报告
+  llmReport    String   @map("llm_report") @db.Text
+  
+  // 报告生成时间
+  generatedAt  DateTime @default(now()) @map("generated_at")
+  
+  // 报告有效期
+  expiresAt    DateTime? @map("expires_at")
+  
+  @@index([projectId, reportType], map: "idx_qc_report_project_type")
+  @@index([generatedAt], map: "idx_qc_report_generated")
+  @@map("qc_reports")
+  @@schema("iit_schema")
+}
+```
+
+---
+
+## 7. 验收标准
+
+### 7.1 功能验收
+
+| 功能 | 验收标准 |
+|------|----------|
+| 变量质控 | 单记录质控 < 100ms；批量 50 记录 < 2s |
+| 入排标准 | LLM 判断准确率 > 90%；单记录 < 3s |
+| 报告生成 | 50 记录的项目报告生成 < 5s |
+| LLM 问答 | 基于报告回答延迟 < 2s |
+| 定时任务 | 每日凌晨自动执行，连续 7 天无故障 |
+
+### 7.2 性能指标
+
+| 指标 | 目标值 |
+|------|--------|
+| HardRuleEngine 执行时间 | < 100ms / 记录 |
+| SoftRuleEngine 执行时间 | < 3s / 记录 |
+| 报告加载时间 | < 200ms |
+| 端到端问答延迟 | < 3s |
+
+### 7.3 业务验收
+
+- [ ] CRA 可以通过 Cockpit 查看所有严重问题
+- [ ] 点击问题可以查看详细数据和证据
+- [ ] 用户可以通过对话询问质控问题，LLM 基于报告回答
+- [ ] 定时任务每日自动执行，生成最新报告
+- [ ] 规则可以通过配置界面增删改
+
+---
+
+## 8. 风险与应对
+
+| 风险 | 影响 | 应对措施 |
+|------|------|----------|
+| LLM 判断不准确 | 入排/AE 检测误报 | 三态管理（Pending → 人工确认） |
+| 规则配置复杂 | 用户上手困难 | 提供预置规则模板 |
+| 数据量大时性能下降 | 质控变慢 | 增量检查 + 分批执行 |
+| REDCap Webhook 不稳定 | 实时质控失效 | 定时任务兜底 |
+
+---
+
+## 9. 参考文档
+
+- [CRA Agent 业务逻辑与执行架构书](../02-技术设计/CRA%20Agent%20业务逻辑与执行架构书%20(1).md)
+- [基于 Skills 的 CRA 规则配置实施指南](../02-技术设计/docs_03-业务模块_IIT%20Manager%20Agent_02-技术设计_11-基于Skills的CRA规则配置实施指南.md)
+- [V2.6 综合开发计划](./IIT%20Manager%20Agent%20V2.6%20综合开发计划.md)
+- [02-核心引擎实现指南](./02-核心引擎实现指南.md)
+
+---
+
+**文档维护人**：AI Agent  
+**最后更新**：2026-02-08
+
+### 更新日志
+
+| 版本 | 日期 | 更新内容 |
+|------|------|----------|
+| V1.0 | 2026-02-08 | 初始版本，基于方案审查和代码分析 |
diff --git a/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 交互协议与 Prompt 最佳实践指南.md b/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 交互协议与 Prompt 最佳实践指南.md
new file mode 100644
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@@ -0,0 +1,122 @@
+# **LLM 交互协议与 Prompt 最佳实践指南**
+
+**文档目的：** 定义“质控报告”的标准上下文格式，并提供配套的 System Prompt，以消除幻觉、确保回复准确性。
+
+**适用版本：** IIT Manager Agent V2.9.1
+
+**创建日期：** 2026-02-08
+
+## **🧠 一、 核心原理：为什么“混合格式”能防幻觉？**
+
+我们将数据格式定义为 **Context Protocol v2.0**，采用 **XML 骨架 \+ Markdown 血肉** 的形式。
+
+### **1.1 格式对比**
+
+| 格式 | 示例 | LLM 视角的优缺点 |
+| :---- | :---- | :---- |
+| **纯 JSON** | {"age": 45, "error": true} | ❌ **缺点**：Token 消耗大，括号层级深时 LLM 容易“晕”，注意力机制容易分散。 |
+| **纯 Markdown** | \*\*Age\*\*: 45 (Error) | ❌ **缺点**：边界不清晰，多条记录容易混在一起，导致“张冠李戴”。 |
+| **混合模式 (推荐)** | \<record id="1"\>- Age: \*\*45\*\*\</record\> | ✅ **优点**：XML \<tag\> 明确告诉 LLM “这是独立的一条记录”，Markdown \*\* 告诉 LLM “这是重点”。 |
+
+### **1.2 防幻觉的三道防线**
+
+1. **防线一：证据注入 (Evidence Injection)**  
+   * **以前**：只给 Age Error。LLM 被问“多少岁”时，只能瞎编。  
+   * **现在**：给 Age Error (Current: 45, Range: 25-35)。LLM 看到了 45，直接引用，无需生成。  
+2. **防线二：预计算 (Pre-computation)**  
+   * **以前**：给 DOB: 1980，让 LLM 算年龄。LLM 数学不好，可能算错。  
+   * **现在**：Node.js 算好 Age: 46，直接喂给 LLM。LLM 只负责读，不负责算。  
+3. **防线三：结构化边界 (XML Boundaries)**  
+   * **以前**：平铺文本。LLM 可能把 A 病人的合并用药安到 B 病人头上。  
+   * **现在**：\<record id="A"\>...\</record\>。强制物理隔离，杜绝串行。
+
+## **📝 二、 Context Protocol v2.0 标准格式**
+
+这是后端 ReportGenerator 需要生成的最终字符串格式。
+
+\<qc\_context project="test0102" generated\_at="2026-02-08"\>
+
+  \<\!-- 1\. 规则定义 (让 LLM 知道判罚标准) \--\>  
+  \<rule\_definitions\>  
+    \<rule id="R\_AGE"\>入排标准 I-01: 年龄应在 25-35 岁之间\</rule\>  
+    \<rule id="R\_ICF"\>伦理合规 E-01: 必须签署知情同意书\</rule\>  
+  \</rule\_definitions\>
+
+  \<\!-- 2\. 严重问题清单 (按受试者分组) \--\>  
+  \<critical\_issues\>  
+      
+    \<subject id="1"\>  
+      \<summary\>存在 2 个严重违规\</summary\>  
+      \<issues\>  
+        1\. \[R\_AGE\] \*\*年龄超标\*\*  
+           \- 现状: 当前年龄 \*\*45岁\*\*  
+           \- 标准: 25-35岁  
+           \- 证据: \`birth\_date\` \= 1981-05-12  
+        2\. \[R\_ICF\] \*\*知情同意缺失\*\*  
+           \- 现状: 字段为空  
+           \- 证据: \`icf\_date\` \= null  
+      \</issues\>  
+    \</subject\>
+
+    \<subject id="10"\>  
+      \<summary\>存在 1 个严重违规\</summary\>  
+      \<issues\>  
+        1\. \[R\_AGE\] \*\*年龄超标\*\*  
+           \- 现状: 当前年龄 \*\*52岁\*\*  
+           \- 证据: \`birth\_date\` \= 1974-02-01  
+      \</issues\>  
+    \</subject\>
+
+  \</critical\_issues\>
+
+\</qc\_context\>
+
+## **🗣️ 三、 配套 Prompt 设计 (System Prompt)**
+
+仅有好的数据格式是不够的，必须用 Prompt 教会 LLM 如何阅读这个格式。
+
+### **3.1 CRA 监查员 System Prompt**
+
+\# Role  
+你是一名资深的临床监查员 (CRA)。你的任务是根据提供的【质控报告上下文】回答用户关于项目质量、违规情况的问题。
+
+\# Input Format  
+你收到的上下文将包含在 \`\<qc\_context\>\` XML 标签中。  
+\- \`\<rule\_definitions\>\`: 定义了项目的质控规则。  
+\- \`\<critical\_issues\>\`: 列出了具体的违规记录，按受试者 (\`\<subject\>\`) 分组。
+
+\# Constraints (绝对准则)  
+1\. \*\*基于证据\*\*：回答必须严格基于 \`\<issues\>\` 中的数据。如果上下文中没有提到某条记录或某个数值，\*\*必须直接说“报告中未包含相关信息”\*\*，严禁编造数值。  
+2\. \*\*引用原文\*\*：在解释违规原因时，必须引用上下文中的 "证据" (Evidence) 字段（例如：“因为患者当前年龄为 45 岁...”）。  
+3\. \*\*结构化输出\*\*：回答多个受试者问题时，请使用 Markdown 列表。  
+4\. \*\*语气专业\*\*：保持客观、冷静的医疗专业语气。
+
+\# Example  
+User: "1号病人有什么问题？"  
+Assistant: "1号受试者存在 \*\*2个严重违规\*\*：  
+1\. \*\*年龄超标\*\*：患者当前 \*\*45岁\*\*，不符合“25-35岁”的入排标准 (R\_AGE)。  
+2\. \*\*伦理缺失\*\*：未检测到知情同意书签署日期 (\`icf\_date\` 为空)。  
+建议立即核查原始病历或剔除该病例。"
+
+## **🔬 四、 验证与测试 (Evaluation)**
+
+### **4.1 幻觉压力测试**
+
+**测试用例 A：询问不存在的数值**
+
+* **Prompt**: "1号病人的血压是多少？"  
+* **Context**: (上下文中只有年龄和ICF问题，没有血压数据)  
+* **预期回答**: "报告中未包含1号受试者的血压数据。当前仅记录了年龄和知情同意书相关的违规信息。"  
+* **失败回答 (幻觉)**: "1号病人的血压是 120/80 mmHg。" (如果 LLM 只有 Message 没有 Evidence，容易顺口胡编一个正常值)
+
+**测试用例 B：询问违规原因**
+
+* **Prompt**: "为什么10号病人年龄违规？"  
+* **Context**: \<subject id="10"\>...当前年龄 \*\*52岁\*\*...\</subject\>  
+* **预期回答**: "因为10号受试者当前年龄为 **52岁**，超出了研究方案规定的 25-35 岁范围。"
+
+### **4.2 结论**
+
+通过 **"XML 结构化 \+ 证据注入 \+ 严格约束 Prompt"** 三位一体的方案，我们可以将幻觉率控制在 **极低水平 (\< 1%)**。
+
+AI 在这里不再是“创造者”，而是精准的“阅读理解者”。
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 友好型质控报告评估与优化方案 V2.md b/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 友好型质控报告评估与优化方案 V2.md
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@@ -0,0 +1,107 @@
+# **LLM 友好型质控报告评估与优化方案**
+
+**文档版本：** v2.1 (基于团队反馈优化)
+
+**评估对象：** qc-report-test0102-pd-study-2026-02-08.xml
+
+**评估日期：** 2026-02-08
+
+## **🚀 一、 核心共识：Context Protocol v2.1**
+
+经过团队讨论，确定采用 **“XML 容器 \+ Markdown 内容”** 的混合模式，并支持 **双格式输出** 以满足不同场景。
+
+### **1.1 双格式策略 (Dual Format Strategy)**
+
+后端 QcService 应支持 format 参数：
+
+* **format=json (Default)**: 面向 **前端 UI**。结构化强，用于渲染热力图、表格。  
+* **format=llm-friendly**: 面向 **LLM Context**。Token 密度高，语义清晰，包含“证据”。
+
+### **1.2 理想的 LLM Context 结构 (V2.1)**
+
+**设计原则**：
+
+1. **去重**：不再单独列出 rule\_definitions，要求每条 issue **自包含**（同时包含现状与标准）。  
+2. **聚合**：按 Record ID 分组。  
+3. **压缩**：使用 Markdown 列表替代冗余的 XML 标签。
+
+\<qc\_context project\_id="test0102" generated="2026-02-08"\>  
+    
+  \<\!-- 1\. 宏观统计 (Aggregate) \--\>  
+  \<summary\>  
+    \- 状态: 13/13 记录存在严重违规 (100% Fail)  
+    \- Top 3 问题:   
+      1\. 年龄超标 (13人)  
+      2\. 未签知情同意书 (13人)  
+      3\. 疼痛评分不达标 (13人)  
+  \</summary\>
+
+  \<\!-- 2\. 问题详情 (Markdown List in XML) \--\>  
+  \<details\>  
+      
+    \<record id="1"\>  
+      \*\*严重违规 (5项)\*\*:  
+      1\. \[R\_AGE\] \*\*年龄超标\*\*: 当前 \*\*45岁\*\* (标准: 25-35岁)。  
+      2\. \[R\_ICF\] \*\*伦理缺失\*\*: \`informed\_consent\` 为空 (必须签署)。  
+      3\. \[R\_VAS\] \*\*入排不符\*\*: VAS评分 \*\*2分\*\* (要求 \>= 4分)。  
+    \</record\>
+
+    \<record id="10"\>  
+      \*\*严重违规 (5项)\*\*:  
+      1\. \[R\_AGE\] \*\*年龄超标\*\*: 当前 \*\*52岁\*\* (标准: 25-35岁)。  
+      \<\!-- 其他同上 \--\>  
+    \</record\>
+
+  \</details\>
+
+\</qc\_context\>
+
+## **🛠️ 二、 实施建议 (Action Items)**
+
+### **2.1 后端改造：让报错信息“自包含”**
+
+这是消除 rule\_definitions 依赖的关键。我们需要在生成 Issue 时，就把标准塞进去。
+
+* **Before (HardRuleEngine)**:  
+  return { message: "年龄不在范围内" }
+
+* **After (HardRuleEngine)**:  
+  // 动态拼接模板  
+  return {   
+      message: \`当前 \*\*${actualValue}\*\* (标准: ${rule.min}-${rule.max})\`,  
+      structured\_evidence: { value: actualValue, range: \[25, 35\] }  
+  }
+
+### **2.2 System Prompt 增强 (V2.1)**
+
+参考团队建议，强化“证据引用”指令。
+
+\# Role  
+你是一名资深的临床监查员 (CRA)。
+
+\# Input Format  
+你收到的 \`\<qc\_context\>\` 包含了项目的质控报告。  
+\- \`\<details\>\` 区域按受试者列出了具体违规项。  
+\- 每一行违规项都包含了 \*\*\[规则ID\]\*\*、\*\*错误类型\*\*、\*\*现状值\*\* 和 \*\*标准值\*\*。
+
+\# Critical Instructions (思维链约束)  
+在回答用户问题时，你必须遵循以下步骤：  
+1\. \*\*定位 (Locate)\*\*: 找到用户询问的 \`\<record\>\`。  
+2\. \*\*提取 (Extract)\*\*: 读取具体的报错行。  
+3\. \*\*引用 (Cite)\*\*: 在回答中明确引用现状值和标准值。  
+   \- ✅ 正确: "1号患者年龄违规，因为他当前 \*\*45岁\*\*，而方案要求 \*\*25-35岁\*\*。"  
+   \- ❌ 错误: "1号患者年龄不对。" (太模糊)  
+   \- ❌ 错误: "1号患者年龄违规，请检查。" (无证据)  
+4\. \*\*诚实 (Grounding)\*\*: 如果报告里没写的数值（比如血压），绝对不要编造，直接回答“报告未提及”。
+
+\# Example  
+User: "10号病人有什么大问题？"  
+Assistant: "10号病人有 \*\*5项严重违规\*\*。最主要的是 \*\*年龄超标\*\*，他当前 \*\*52岁\*\*，远超出了 \*\*25-35岁\*\* 的入排标准。此外还存在伦理知情同意书缺失的问题。"
+
+## **📊 三、 收益预估**
+
+1. **Token 节省**：相比 V1.0 XML，V2.1 混合格式预计节省 **40%-60%** 的 Token（去掉了大量的 \<issue\>, \<field\>, \<message\> 标签）。  
+2. **幻觉消除**：通过“自包含”设计，LLM 不需要跨段落去查找规则定义，所有信息都在一行内，上下文注意力极其集中。  
+3. **开发解耦**：前端用 JSON 渲染界面，LLM 用 Text 文本推理，互不干扰。
+
+**结论：** 团队的建议非常棒。V2.1 方案已采纳 **混合格式** \+ **自包含报错** \+ **引用增强 Prompt**，这是目前最优的工程解法。
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 友好型质控报告评估与优化方案.md b/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 友好型质控报告评估与优化方案.md
new file mode 100644
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--- /dev/null
+++ b/docs/03-业务模块/IIT Manager Agent/05-测试文档/LLM 友好型质控报告评估与优化方案.md	
@@ -0,0 +1,120 @@
+# **LLM 友好型质控报告评估与优化方案**
+
+**评估对象：** qc-report-test0102-pd-study-2026-02-08.xml
+
+**评估目的：** 确定该格式是否适合作为 Context 喂给 LLM 以回答用户提问。
+
+**评估日期：** 2026-02-08
+
+## **📊 一、 现状评估 (Current State Analysis)**
+
+### **1\. 评分卡**
+
+| 维度 | 评分 (1-10) | 评价 |
+| :---- | :---- | :---- |
+| **结构化程度** | 9/10 | XML 结构清晰，解析容易。 |
+| **Token 效率** | 3/10 | **极差**。重复信息太多（如 rule\_name 重复 64 次）。 |
+| **信息完整性** | 4/10 | **缺失核心证据**。只说了“错”，没说“值为多少”。 |
+| **语义清晰度** | 5/10 | rule="unknown" 对 AI 毫无帮助，缺乏语义标签。 |
+
+### **2\. 核心缺陷分析**
+
+#### **❌ 缺陷 1：缺乏“原始值” (The "Evidence Gap")**
+
+* **现状**：  
+  \<message\>年龄不在 25-35 岁范围内\</message\>  
+  \<field\>age\</field\>
+
+* **LLM 的困惑**："我知道年龄不对，但这个病人到底几岁？是 24 岁（轻微偏差）还是 80 岁（严重偏差）？用户如果问我‘为什么报错’，我只能复读 Message，无法解释原因。"
+
+#### **❌ 缺陷 2：Token 冗余 (The "Echo Chamber")**
+
+* **现状**：  
+  13 条记录都有“年龄”问题，rule\_name 和 message 重复了 13 次。  
+* **LLM 的困惑**："为什么要让我读 13 遍同样的一句话？这浪费了宝贵的上下文窗口。"
+
+#### **❌ 缺陷 3：逻辑扁平 (Lack of Hierarchy)**
+
+* **现状**：  
+  所有问题平铺在 \<critical\_issues\> 下，没有按 Record ID 聚合。  
+* **LLM 的困惑**："如果用户问‘001号病人有哪些问题？’，我得遍历整个列表去挑出 record=1 的项，容易看漏。"
+
+## **🚀 二、 优化方案：Context Protocol v2.0**
+
+根据我们的 **CRA Agent 深度设计**，我们需要将报告重构为 **“以实体为中心，以证据为支撑”** 的结构。
+
+### **2.1 理想的 Context 结构 (Gold Standard)**
+
+建议采用 **混合模式**：XML 定义边界，Markdown 描述详情。
+
+\<qc\_context project\_id="test0102" generated="2026-02-08"\>  
+    
+  \<\!-- 1\. 宏观统计 (Aggregate) \--\>  
+  \<overview\>  
+    \- 总记录数: 13 | ❌ 严重违规: 13人 (100%)  
+    \- 主要问题: 年龄超标 (13), 未签知情同意书 (13), 疼痛评分不达标 (13)  
+  \</overview\>
+
+  \<\!-- 2\. 规则定义 (Reference) \- 只定义一次，省 Token \--\>  
+  \<rule\_definitions\>  
+    \<rule id="R\_AGE" tag="\#demographics"\>年龄应在 25-35 岁之间\</rule\>  
+    \<rule id="R\_ICF" tag="\#ethics"\>必须签署知情同意书\</rule\>  
+  \</rule\_definitions\>
+
+  \<\!-- 3\. 问题详情 (Grouped by Record) \--\>  
+  \<issues\_list\>  
+      
+    \<record id="1" status="CRITICAL"\>  
+      \<summary\>存在 5 个严重违规\</summary\>  
+      \<details\>  
+        \- \[R\_AGE\] ❌ \*\*年龄违规\*\*: 当前值 \`45\` (不在 25-35 范围内)。  
+        \- \[R\_ICF\] ❌ \*\*伦理违规\*\*: \`informed\_consent\` 为空。  
+        \- \[R\_VAS\] ❌ \*\*入排不符\*\*: VAS评分 \`2\` (要求 \>= 4)。  
+      \</details\>  
+    \</record\>
+
+    \<record id="10" status="CRITICAL"\>  
+      \<summary\>存在 5 个严重违规\</summary\>  
+      \<details\>  
+        \- \[R\_AGE\] ❌ \*\*年龄违规\*\*: 当前值 \`52\`。  
+        \<\!-- 省略重复描述，仅列出差异或关键点 \--\>  
+      \</details\>  
+    \</record\>
+
+  \</issues\_list\>
+
+\</qc\_context\>
+
+## **🛠️ 三、 实施建议 (Action Items)**
+
+### **3.1 后端代码调整 (QcService / ReportGenerator)**
+
+你需要修改生成 XML 的逻辑，不仅要查 iit\_qc\_logs，还要关联 **原始数据**。
+
+1. **补充 value 字段**：  
+   在存入 iit\_qc\_logs 时，或者在生成报告时，必须把触发报错的 **具体数值** 写进去。  
+   * *Bad:* { "message": "Age error" }  
+   * *Good:* { "message": "Age error", "evidence": { "value": 45, "threshold": "25-35" } }  
+2. **补充 rule\_id 和 tag**：  
+   目前的 rule="unknown" 是不可接受的。  
+   * 在 HardRuleEngine 里，每条规则必须有一个唯一的 code (例如 AGE\_CHECK)。  
+   * 在 iit\_skills 配置中，关联 Tags。  
+3. **按受试者聚合 (Group By Record)**：  
+   不要输出扁平的 List，要输出 Map：Map\<RecordId, Issues\[\]\>。
+
+### **3.2 优化后的 LLM 交互流程**
+
+当用户问：“**为什么 1 号病人不合格？**”
+
+* **旧 XML**：LLM 看到 "年龄不在范围内"，只能回答“因为年龄不对”。  
+* **新 XML**：LLM 看到 当前值 45 (要求 25-35)，可以回答：  
+  “1号病人不合格主要有 3 个原因：  
+  1. **年龄不符**：患者 **45岁**，超出了研究要求的 25-35 岁范围。  
+  2. **疼痛评分不足**：VAS 评分为 **2分**，未达到入组要求的 4分。  
+  3. **伦理缺失**：系统中未查询到知情同意书签署记录。”
+
+### **3.3 总结**
+
+**现有报告是给程序员调试用的，不是给 LLM 用的。**
+
+请按照 **Context Protocol** 规范，增加 **Evidence (原始值)**，增加 **Grouping (聚合)**，并消除冗余文本。
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/05-测试文档/qc-report-test0102-pd-study-2026-02-08.xml b/docs/03-业务模块/IIT Manager Agent/05-测试文档/qc-report-test0102-pd-study-2026-02-08.xml
new file mode 100644
index 00000000..efa2868f
--- /dev/null
+++ b/docs/03-业务模块/IIT Manager Agent/05-测试文档/qc-report-test0102-pd-study-2026-02-08.xml	
@@ -0,0 +1,320 @@
+<?xml version="1.0" encoding="UTF-8"?>
+<qc_report project_id="test0102-pd-study" project_name="test0207" generated="2026-02-08T08:14:32.847Z">
+  
+  <summary>
+    <total_records>13</total_records>
+    <completed_records>0</completed_records>
+    <critical_issues>64</critical_issues>
+    <warning_issues>0</warning_issues>
+    <pending_queries>0</pending_queries>
+    <pass_rate>0%</pass_rate>
+    <last_qc_time>2026-02-08T05:30:56.082Z</last_qc_time>
+  </summary>
+
+  <critical_issues count="64">
+    <issue record="1" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:55.980Z</detected_at>
+    </issue>
+    <issue record="1" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:55.980Z</detected_at>
+    </issue>
+    <issue record="1" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:55.980Z</detected_at>
+    </issue>
+    <issue record="1" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:55.980Z</detected_at>
+    </issue>
+    <issue record="1" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:55.980Z</detected_at>
+    </issue>
+    <issue record="10" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.060Z</detected_at>
+    </issue>
+    <issue record="10" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.060Z</detected_at>
+    </issue>
+    <issue record="10" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.060Z</detected_at>
+    </issue>
+    <issue record="10" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.060Z</detected_at>
+    </issue>
+    <issue record="10" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.060Z</detected_at>
+    </issue>
+    <issue record="11" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.068Z</detected_at>
+    </issue>
+    <issue record="11" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.068Z</detected_at>
+    </issue>
+    <issue record="11" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.068Z</detected_at>
+    </issue>
+    <issue record="11" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.068Z</detected_at>
+    </issue>
+    <issue record="11" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.068Z</detected_at>
+    </issue>
+    <issue record="12" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.075Z</detected_at>
+    </issue>
+    <issue record="12" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.075Z</detected_at>
+    </issue>
+    <issue record="12" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.075Z</detected_at>
+    </issue>
+    <issue record="12" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.075Z</detected_at>
+    </issue>
+    <issue record="13" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.082Z</detected_at>
+    </issue>
+    <issue record="13" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.082Z</detected_at>
+    </issue>
+    <issue record="13" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.082Z</detected_at>
+    </issue>
+    <issue record="13" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.082Z</detected_at>
+    </issue>
+    <issue record="13" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.082Z</detected_at>
+    </issue>
+    <issue record="2" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:55.990Z</detected_at>
+    </issue>
+    <issue record="2" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:55.990Z</detected_at>
+    </issue>
+    <issue record="2" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:55.990Z</detected_at>
+    </issue>
+    <issue record="2" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:55.990Z</detected_at>
+    </issue>
+    <issue record="2" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:55.990Z</detected_at>
+    </issue>
+    <issue record="3" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:55.998Z</detected_at>
+    </issue>
+    <issue record="3" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:55.998Z</detected_at>
+    </issue>
+    <issue record="3" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:55.998Z</detected_at>
+    </issue>
+    <issue record="3" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:55.998Z</detected_at>
+    </issue>
+    <issue record="3" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:55.998Z</detected_at>
+    </issue>
+    <issue record="4" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.008Z</detected_at>
+    </issue>
+    <issue record="4" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.008Z</detected_at>
+    </issue>
+    <issue record="4" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.008Z</detected_at>
+    </issue>
+    <issue record="4" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.008Z</detected_at>
+    </issue>
+    <issue record="4" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.008Z</detected_at>
+    </issue>
+    <issue record="5" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.019Z</detected_at>
+    </issue>
+    <issue record="5" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.019Z</detected_at>
+    </issue>
+    <issue record="5" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.019Z</detected_at>
+    </issue>
+    <issue record="5" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.019Z</detected_at>
+    </issue>
+    <issue record="5" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.019Z</detected_at>
+    </issue>
+    <issue record="6" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.028Z</detected_at>
+    </issue>
+    <issue record="6" rule="unknown" severity="critical">
+      <rule_name>出生日期不在 1989-01-01 至 2008-01-01 范围内</rule_name>
+      <message>出生日期不在 1989-01-01 至 2008-01-01 范围内</message>
+      <field>birth_date</field>
+      <detected_at>2026-02-08T05:30:56.028Z</detected_at>
+    </issue>
+    <issue record="6" rule="unknown" severity="critical">
+      <rule_name>月经周期不在 21-35 天范围内（28±7天）</rule_name>
+      <message>月经周期不在 21-35 天范围内（28±7天）</message>
+      <field>menstrual_cycle</field>
+      <detected_at>2026-02-08T05:30:56.028Z</detected_at>
+    </issue>
+    <issue record="6" rule="unknown" severity="critical">
+      <rule_name>VAS 疼痛评分 &lt; 4 分，不符合入组条件</rule_name>
+      <message>VAS 疼痛评分 &lt; 4 分，不符合入组条件</message>
+      <field>vas_score</field>
+      <detected_at>2026-02-08T05:30:56.028Z</detected_at>
+    </issue>
+    <issue record="6" rule="unknown" severity="critical">
+      <rule_name>未签署知情同意书</rule_name>
+      <message>未签署知情同意书</message>
+      <field>informed_consent</field>
+      <detected_at>2026-02-08T05:30:56.028Z</detected_at>
+    </issue>
+    <issue record="7" rule="unknown" severity="critical">
+      <rule_name>年龄不在 25-35 岁范围内</rule_name>
+      <message>年龄不在 25-35 岁范围内</message>
+      <field>age</field>
+      <detected_at>2026-02-08T05:30:56.038Z</detected_at>
+    </issue>
+    <!-- ... 还有 14 个严重问题未显示 -->
+  </critical_issues>
+
+  <warning_issues count="0" />
+
+</qc_report>
\ No newline at end of file
diff --git a/docs/03-业务模块/IIT Manager Agent/06-开发记录/2026-02-08-事件级质控与报告优化开发记录.md b/docs/03-业务模块/IIT Manager Agent/06-开发记录/2026-02-08-事件级质控与报告优化开发记录.md
new file mode 100644
index 00000000..fb2c05a2
--- /dev/null
+++ b/docs/03-业务模块/IIT Manager Agent/06-开发记录/2026-02-08-事件级质控与报告优化开发记录.md	
@@ -0,0 +1,217 @@
+# 2026-02-08 事件级质控与报告优化开发记录
+
+> **开发日期：** 2026-02-08  
+> **开发人员：** AI Assistant  
+> **版本：** V3.1  
+> **状态：** ✅ 基本测试成功
+
+---
+
+## 📋 开发概述
+
+本次开发主要完成了 IIT Manager Agent 质控系统的重大架构升级，从"记录级合并质控"改为"事件级独立质控"，同时优化了质控报告生成逻辑和 AI 对话能力。
+
+---
+
+## 🎯 核心改动
+
+### 1. 事件级质控架构（V3.1）
+
+**问题背景：**
+- REDCap 纵向研究中，一个 record_id 可能有多个事件（如筛选期、随访1、随访2等）
+- 之前的质控将所有事件的数据合并到一条记录，导致数据覆盖问题
+- 不同事件的表单应该独立质控
+
+**解决方案：**
+
+| 改动文件 | 改动内容 |
+|---------|---------|
+| `RedcapAdapter.ts` | 新增 `getAllRecordsByEvent()` 方法，按 record+event 返回独立数据单元 |
+| `RedcapAdapter.ts` | 新增 `getFormEventMapping()` 和 `getEvents()` 获取事件配置 |
+| `RedcapAdapter.ts` | 新增 `getFormCompletionStatusByEvent()` 按事件获取表单完成状态 |
+| `HardRuleEngine.ts` | `QCRule` 接口新增 `applicableEvents` 和 `applicableForms` 字段 |
+| `SoftRuleEngine.ts` | `SoftRuleCheck` 接口同样新增事件/表单适用性字段 |
+| `SkillRunner.ts` | 重构 `runByTrigger()` 按 record+event 独立执行质控 |
+| `SkillRunner.ts` | 新增 `filterApplicableRules()` 方法，按事件/表单动态过滤规则 |
+| `SkillRunner.ts` | `SkillRunResult` 新增 `eventName`、`eventLabel`、`forms` 字段 |
+| `SkillRunner.ts` | `saveQcLog()` 现在保存 `eventId` 到数据库 |
+
+**架构变化：**
+
+```
+之前（记录级合并）：
+Record 1 = Event A 数据 + Event B 数据 + ... (合并可能覆盖)
+
+之后（事件级独立）：
+Record 1 + Event A = 独立质控单元 1
+Record 1 + Event B = 独立质控单元 2
+...
+```
+
+### 2. 质控报告优化
+
+**问题背景：**
+- 报告从多个事件收集问题，导致同一规则重复出现
+- 报告使用缓存，不是最新数据
+- 显示限制导致部分问题被隐藏
+
+**解决方案：**
+
+| 改动文件 | 改动内容 |
+|---------|---------|
+| `QcReportService.ts` | SQL 查询改用 `DISTINCT ON (record_id, event_id)` |
+| `QcReportService.ts` | 新增 `deduplicateIssues()` 按 recordId+ruleId 去重 |
+| `QcReportService.ts` | 统计计数也按 recordId+ruleId 去重（使用 Set） |
+| `QcReportService.ts` | 移除所有 slice 显示限制，显示所有问题 |
+| `QcReportService.ts` | 兼容新旧两种 issues 格式（数组 vs { items: [...] }）|
+
+### 3. 批量操作 API 更新
+
+| 改动文件 | 改动内容 |
+|---------|---------|
+| `iitBatchController.ts` | `batchQualityCheck` 改用 `SkillRunner.runByTrigger()` |
+| `ToolsService.ts` | `batch_quality_check` 工具同样改用事件级质控 |
+
+### 4. 前端优化
+
+| 改动文件 | 改动内容 |
+|---------|---------|
+| `QcReportDrawer.tsx` | 导出 XML 前自动刷新报告（确保获取最新数据）|
+| `QcReportDrawer.tsx` | 文件名添加时分（HHMM格式）便于区分 |
+| `IitQcCockpitPage.tsx` | 删除重复的"全量质控"按钮（保留配置页的）|
+
+### 5. AI 对话增强
+
+| 改动文件 | 改动内容 |
+|---------|---------|
+| `ChatService.ts` | 增强意图识别，支持更多质控查询表达方式 |
+| `PromptBuilder.ts` | 修复 `this` 上下文丢失导致的 500 错误 |
+
+---
+
+## 🐛 修复的 Bug
+
+### Bug 1: `formatPatientData` undefined 错误
+
+**现象：** 点击记录详情时返回 500 错误
+
+**原因：** `buildClinicalSlice` 函数导出时丢失了 `this` 上下文
+
+**修复：** 将 `this.formatPatientData` 改为 `PromptBuilder.formatPatientData`
+
+### Bug 2: 质控报告重复问题
+
+**现象：** Record 1 显示 14 条违规，实际应该是 5 条
+
+**原因：** 同一规则在多个事件中执行，结果都被收集到报告中
+
+**修复：** 按 `recordId + ruleId` 去重，只保留最新结果
+
+### Bug 3: 报告记录数不正确
+
+**现象：** 显示 13 条记录，实际有 14 条
+
+**原因：** 从 `iitRecordSummary` 获取记录数，该表可能缺少记录
+
+**修复：** 从质控日志获取独立 `record_id` 数量
+
+### Bug 4: AI 无法回答质控问题
+
+**现象：** 问"严重违规有几项"，AI 说"没有相关信息"
+
+**原因：** 意图识别规则不够全面
+
+**修复：** 增加更多匹配模式（质控问题、严重违规、record问题等）
+
+---
+
+## 📁 涉及文件清单
+
+### 后端核心文件
+
+```
+backend/src/modules/iit-manager/
+├── adapters/
+│   └── RedcapAdapter.ts              ✅ 新增 3 个方法
+├── engines/
+│   ├── HardRuleEngine.ts             ✅ QCRule 接口扩展
+│   ├── SoftRuleEngine.ts             ✅ SoftRuleCheck 接口扩展
+│   └── SkillRunner.ts                ✅ 事件级质控核心重构
+├── services/
+│   ├── QcReportService.ts            ✅ 去重 + 移除限制
+│   ├── ChatService.ts                ✅ 意图识别增强
+│   ├── PromptBuilder.ts              ✅ 修复 this 上下文
+│   └── ToolsService.ts               ✅ batch_quality_check 更新
+
+backend/src/modules/admin/iit-projects/
+└── iitBatchController.ts             ✅ 使用 SkillRunner
+```
+
+### 前端文件
+
+```
+frontend-v2/src/modules/admin/
+├── components/qc-cockpit/
+│   └── QcReportDrawer.tsx            ✅ 自动刷新 + 文件名优化
+└── pages/
+    └── IitQcCockpitPage.tsx          ✅ 删除重复按钮
+```
+
+---
+
+## 🧪 测试验证
+
+### 测试结果
+
+| 测试项 | 结果 | 备注 |
+|--------|------|------|
+| 事件级质控执行 | ✅ | 14 条记录 × 5 个事件 = 70 个质控单元 |
+| 规则动态过滤 | ✅ | 配置 applicableForms 后规则只在相关事件执行 |
+| 报告去重 | ✅ | 168 条问题去重后变为 69 条 |
+| XML 导出 | ✅ | 自动刷新 + 显示所有问题 |
+| AI 质控查询 | ✅ | 能正确回答"严重违规有几项" |
+| 详情页 500 错误 | ✅ | formatPatientData 修复后正常 |
+
+---
+
+## 📝 配置说明
+
+### 规则适用性配置示例
+
+```typescript
+// 在 Skill 配置中设置规则的适用表单
+{
+  "id": "inc_001",
+  "name": "年龄范围检查",
+  "applicableForms": ["basic_demography_form"],  // 只在人口学表单执行
+  "applicableEvents": []  // 空数组 = 适用所有事件
+}
+```
+
+### 执行配置更新脚本
+
+```bash
+cd backend
+npx tsx update-skill-applicable-forms.ts
+```
+
+---
+
+## 🔄 后续优化建议
+
+1. **规则配置 UI**：在管理端添加规则 → 表单映射的可视化配置界面
+2. **事件标签显示**：在报告中显示事件的中文标签（如"筛选期"）而非唯一标识
+3. **增量质控**：只对有变化的事件执行质控，避免全量重算
+4. **质控历史**：保留历史质控结果，支持趋势分析
+
+---
+
+## 📚 相关文档
+
+- [模块状态文档](../00-模块当前状态与开发指南.md)
+- [实时质控系统开发记录](./2026-02-07-实时质控系统开发记录.md)
+- [质控系统 UI 与 LLM 格式优化计划](../04-开发计划/07-质控系统UI与LLM格式优化计划.md)
+
+---
+
+> **总结：** 本次开发完成了 IIT 质控系统从"记录级"到"事件级"的架构升级，解决了数据合并覆盖、报告重复、AI 无法回答等多个问题，为 REDCap 纵向研究提供了更精确的质控能力。
diff --git a/frontend-v2/src/App.tsx b/frontend-v2/src/App.tsx
index 61056225..be58c183 100644
--- a/frontend-v2/src/App.tsx
+++ b/frontend-v2/src/App.tsx
@@ -27,6 +27,7 @@ import SystemKbDetailPage from './modules/admin/pages/SystemKbDetailPage'
 // IIT 项目管理
 import IitProjectListPage from './modules/admin/pages/IitProjectListPage'
 import IitProjectDetailPage from './modules/admin/pages/IitProjectDetailPage'
+import IitQcCockpitPage from './modules/admin/pages/IitQcCockpitPage'
 // 运营日志
 import ActivityLogsPage from './pages/admin/ActivityLogsPage'
 // 个人中心页面
@@ -123,6 +124,7 @@ function App() {
                   {/* IIT 项目管理 */}
                   <Route path="iit-projects" element={<IitProjectListPage />} />
                   <Route path="iit-projects/:id" element={<IitProjectDetailPage />} />
+                  <Route path="iit-projects/:id/cockpit" element={<IitQcCockpitPage />} />
                   {/* 运营日志 */}
                   <Route path="activity-logs" element={<ActivityLogsPage />} />
                   {/* 系统配置 */}
diff --git a/frontend-v2/src/modules/admin/api/iitProjectApi.ts b/frontend-v2/src/modules/admin/api/iitProjectApi.ts
index 42d761e6..54a4c505 100644
--- a/frontend-v2/src/modules/admin/api/iitProjectApi.ts
+++ b/frontend-v2/src/modules/admin/api/iitProjectApi.ts
@@ -18,6 +18,10 @@ import type {
   RoleOption,
   KnowledgeBaseOption,
 } from '../types/iitProject';
+import type {
+  QcCockpitData,
+  RecordDetail,
+} from '../types/qcCockpit';
 
 const BASE_URL = '/api/v1/admin/iit-projects';
 
@@ -260,3 +264,93 @@ export async function batchSummary(projectId: string): Promise<{
   const response = await apiClient.post(`${BASE_URL}/${projectId}/batch-summary`);
   return response.data;
 }
+
+// ==================== 质控驾驶舱 ====================
+
+/** 获取质控驾驶舱数据 */
+export async function getQcCockpitData(projectId: string): Promise<QcCockpitData> {
+  const response = await apiClient.get(`${BASE_URL}/${projectId}/qc-cockpit`);
+  return response.data.data;
+}
+
+/** 获取记录质控详情 */
+export async function getQcRecordDetail(
+  projectId: string,
+  recordId: string,
+  formName: string
+): Promise<RecordDetail> {
+  const response = await apiClient.get(
+    `${BASE_URL}/${projectId}/qc-cockpit/records/${recordId}`,
+    { params: { formName } }
+  );
+  return response.data.data;
+}
+
+/** 质控报告类型 */
+export interface QcReport {
+  projectId: string;
+  reportType: 'daily' | 'weekly' | 'on_demand';
+  generatedAt: string;
+  expiresAt: string | null;
+  summary: {
+    totalRecords: number;
+    completedRecords: number;
+    criticalIssues: number;
+    warningIssues: number;
+    pendingQueries: number;
+    passRate: number;
+    lastQcTime: string | null;
+  };
+  criticalIssues: Array<{
+    recordId: string;
+    ruleId: string;
+    ruleName: string;
+    severity: 'critical' | 'warning' | 'info';
+    message: string;
+    field?: string;
+    actualValue?: any;
+    expectedValue?: any;
+    detectedAt: string;
+  }>;
+  warningIssues: Array<{
+    recordId: string;
+    ruleId: string;
+    ruleName: string;
+    severity: 'critical' | 'warning' | 'info';
+    message: string;
+    field?: string;
+    detectedAt: string;
+  }>;
+  formStats: Array<{
+    formName: string;
+    formLabel: string;
+    totalChecks: number;
+    passed: number;
+    failed: number;
+    passRate: number;
+  }>;
+  llmFriendlyXml: string;
+}
+
+/** 获取质控报告 */
+export async function getQcReport(
+  projectId: string,
+  format: 'json' | 'xml' = 'json'
+): Promise<QcReport | string> {
+  const response = await apiClient.get(
+    `${BASE_URL}/${projectId}/qc-cockpit/report`,
+    { 
+      params: { format },
+      responseType: format === 'xml' ? 'text' : 'json',
+    }
+  );
+  return format === 'xml' ? response.data : response.data.data;
+}
+
+/** 刷新质控报告 */
+export async function refreshQcReport(projectId: string): Promise<QcReport> {
+  const response = await apiClient.post(
+    `${BASE_URL}/${projectId}/qc-cockpit/report/refresh`
+  );
+  return response.data.data;
+}
diff --git a/frontend-v2/src/modules/admin/components/qc-cockpit/QcDetailDrawer.tsx b/frontend-v2/src/modules/admin/components/qc-cockpit/QcDetailDrawer.tsx
new file mode 100644
index 00000000..59438b1a
--- /dev/null
+++ b/frontend-v2/src/modules/admin/components/qc-cockpit/QcDetailDrawer.tsx
@@ -0,0 +1,327 @@
+/**
+ * 质控详情抽屉组件
+ * 
+ * 展示受试者某个表单/访视的详细质控信息
+ * - 左侧：真实数据 (Source of Truth)
+ * - 右侧：AI 诊断报告 + LLM Trace
+ */
+
+import React, { useState, useEffect } from 'react';
+import { Drawer, Button, Spin, message, Empty, Tag, Space, Tooltip } from 'antd';
+import {
+  CloseOutlined,
+  ExclamationCircleOutlined,
+  WarningOutlined,
+  CheckCircleOutlined,
+  DatabaseOutlined,
+  RobotOutlined,
+  CodeOutlined,
+  ExportOutlined,
+  DeleteOutlined,
+  QuestionCircleOutlined,
+} from '@ant-design/icons';
+import * as iitProjectApi from '../../api/iitProjectApi';
+import type { HeatmapCell, RecordDetail } from '../../types/qcCockpit';
+
+interface QcDetailDrawerProps {
+  open: boolean;
+  onClose: () => void;
+  cell: HeatmapCell | null;
+  projectId: string;
+  projectName: string;
+}
+
+const QcDetailDrawer: React.FC<QcDetailDrawerProps> = ({
+  open,
+  onClose,
+  cell,
+  projectId,
+  projectName,
+}) => {
+  const [loading, setLoading] = useState(false);
+  const [detail, setDetail] = useState<RecordDetail | null>(null);
+  const [activeTab, setActiveTab] = useState<'report' | 'trace'>('report');
+
+  // 加载详情
+  useEffect(() => {
+    if (open && cell) {
+      loadDetail();
+    }
+  }, [open, cell]);
+
+  const loadDetail = async () => {
+    if (!cell) return;
+    setLoading(true);
+    try {
+      const data = await iitProjectApi.getQcRecordDetail(
+        projectId,
+        cell.recordId,
+        cell.formName
+      );
+      setDetail(data);
+    } catch (error: any) {
+      message.error(error.message || '加载详情失败');
+    } finally {
+      setLoading(false);
+    }
+  };
+
+  const handleConfirmViolation = () => {
+    message.info('确认违规功能开发中...');
+  };
+
+  const handleSendQuery = () => {
+    message.info('发送 Query 功能开发中...');
+  };
+
+  const handleIgnore = () => {
+    message.info('忽略功能开发中...');
+  };
+
+  const handleOpenRedcap = () => {
+    message.info('打开 REDCap 功能开发中...');
+  };
+
+  if (!cell) return null;
+
+  // 从 recordId 提取数字部分作为头像
+  const avatarNum = cell.recordId.replace(/\D/g, '').slice(-2) || '00';
+
+  return (
+    <Drawer
+      title={null}
+      placement="right"
+      width={1000}
+      open={open}
+      onClose={onClose}
+      closable={false}
+      styles={{ body: { padding: 0, display: 'flex', flexDirection: 'column' } }}
+    >
+      {/* 抽屉头部 */}
+      <div style={{
+        padding: '16px 24px',
+        borderBottom: '1px solid #f0f0f0',
+        display: 'flex',
+        justifyContent: 'space-between',
+        alignItems: 'center',
+        background: '#fafafa',
+      }}>
+        <div className="qc-drawer-header">
+          <div className="qc-drawer-avatar">{avatarNum}</div>
+          <div className="qc-drawer-info">
+            <div className="qc-drawer-title">受试者 {cell.recordId}</div>
+            <div className="qc-drawer-subtitle">
+              访视阶段: {cell.formName} | 
+              项目: {projectName} | 
+              {detail?.entryTime && ` 录入时间: ${detail.entryTime}`}
+            </div>
+          </div>
+        </div>
+        <Space>
+          <Tooltip title="在 REDCap 中查看">
+            <Button icon={<ExportOutlined />} onClick={handleOpenRedcap}>
+              REDCap
+            </Button>
+          </Tooltip>
+          <Button type="text" icon={<CloseOutlined />} onClick={onClose} />
+        </Space>
+      </div>
+
+      {/* 抽屉内容 */}
+      <Spin spinning={loading}>
+        {detail ? (
+          <div className="qc-drawer-content">
+            {/* 左栏：真实数据 */}
+            <div className="qc-drawer-left">
+              <div className="qc-drawer-section">
+                <div className="qc-drawer-section-title">
+                  <DatabaseOutlined />
+                  真实数据 ({cell.formName})
+                  <Tag color="default" style={{ marginLeft: 8 }}>Read Only</Tag>
+                </div>
+              </div>
+              <div style={{ padding: 16 }}>
+                <div className="qc-field-list">
+                  {Object.entries(detail.data).map(([key, value]) => {
+                    // 查找该字段是否有问题
+                    const issue = detail.issues.find(i => i.field === key);
+                    const fieldMeta = detail.fieldMetadata?.[key];
+                    const label = fieldMeta?.label || key;
+                    
+                    return (
+                      <div key={key} className="qc-field-item">
+                        <label className="qc-field-label">{label}</label>
+                        <div className={`qc-field-value ${issue ? (issue.severity === 'critical' ? 'error' : 'warning') : ''}`}>
+                          {value ?? <span style={{ color: '#999' }}>未填写</span>}
+                          {issue && (
+                            <ExclamationCircleOutlined 
+                              style={{ 
+                                marginLeft: 8, 
+                                color: issue.severity === 'critical' ? '#ff4d4f' : '#faad14' 
+                              }} 
+                            />
+                          )}
+                        </div>
+                        {issue && (
+                          <div style={{ fontSize: 12, color: '#ff4d4f', marginTop: 4 }}>
+                            {issue.message}
+                            {fieldMeta?.normalRange && (
+                              <span style={{ marginLeft: 8, color: '#999' }}>
+                                正常范围: {fieldMeta.normalRange.min ?? '-'} ~ {fieldMeta.normalRange.max ?? '-'}
+                              </span>
+                            )}
+                          </div>
+                        )}
+                      </div>
+                    );
+                  })}
+                </div>
+              </div>
+            </div>
+
+            {/* 右栏：AI 诊断 + Trace */}
+            <div className="qc-drawer-right">
+              {/* Tab 切换 */}
+              <div className="qc-drawer-tabs">
+                <div 
+                  className={`qc-drawer-tab ${activeTab === 'report' ? 'active' : ''}`}
+                  onClick={() => setActiveTab('report')}
+                >
+                  <RobotOutlined style={{ marginRight: 8 }} />
+                  智能诊断报告
+                </div>
+                <div 
+                  className={`qc-drawer-tab ${activeTab === 'trace' ? 'active' : ''}`}
+                  onClick={() => setActiveTab('trace')}
+                >
+                  <CodeOutlined style={{ marginRight: 8 }} />
+                  LLM Trace (透视)
+                </div>
+              </div>
+
+              {/* Tab 内容 */}
+              {activeTab === 'report' ? (
+                <div style={{ padding: 16, overflowY: 'auto' }}>
+                  {detail.issues.length > 0 ? (
+                    detail.issues.map((issue, idx) => (
+                      <div 
+                        key={idx} 
+                        className={`qc-issue-card ${issue.severity === 'critical' ? 'critical' : 'warning'}`}
+                      >
+                        <div className={`qc-issue-card-header ${issue.severity === 'critical' ? 'critical' : 'warning'}`}>
+                          <span className={`qc-issue-card-title ${issue.severity === 'critical' ? 'critical' : 'warning'}`}>
+                            {issue.severity === 'critical' ? (
+                              <><ExclamationCircleOutlined /> 违反入排标准 (Critical)</>
+                            ) : (
+                              <><WarningOutlined /> 数据完整性警告</>
+                            )}
+                          </span>
+                          <span className="qc-issue-card-confidence">
+                            置信度: {issue.confidence || 'High'}
+                          </span>
+                        </div>
+                        <div className="qc-issue-card-body">
+                          <p className="qc-issue-card-description">
+                            <strong>AI 观点：</strong>{issue.message}
+                          </p>
+                          <div className="qc-issue-card-evidence">
+                            <p style={{ fontWeight: 600, marginBottom: 8 }}>原始证据链 (Evidence Chain):</p>
+                            <ul style={{ paddingLeft: 16, margin: 0 }}>
+                              <li>Variable: <code>{issue.field}</code> = {String(issue.actualValue)}</li>
+                              {issue.expectedValue && (
+                                <li>Standard: {issue.expectedValue}</li>
+                              )}
+                              <li>Form: {cell.formName}</li>
+                            </ul>
+                          </div>
+                        </div>
+                        <div className="qc-issue-card-footer">
+                          {issue.severity === 'critical' && (
+                            <Button 
+                              type="primary" 
+                              danger 
+                              size="small"
+                              onClick={handleConfirmViolation}
+                            >
+                              确认违规 (PD)
+                            </Button>
+                          )}
+                          <Button size="small" onClick={handleSendQuery}>
+                            <QuestionCircleOutlined /> 发送 Query
+                          </Button>
+                          <Button 
+                            type="text" 
+                            size="small" 
+                            icon={<DeleteOutlined />}
+                            onClick={handleIgnore}
+                          >
+                            忽略
+                          </Button>
+                        </div>
+                      </div>
+                    ))
+                  ) : (
+                    <div style={{ textAlign: 'center', padding: 40 }}>
+                      <CheckCircleOutlined style={{ fontSize: 48, color: '#52c41a' }} />
+                      <p style={{ marginTop: 16, color: '#52c41a' }}>
+                        所有检查项均已通过
+                      </p>
+                    </div>
+                  )}
+                </div>
+              ) : (
+                /* LLM Trace Tab */
+                <div className="qc-llm-trace">
+                  <div className="qc-llm-trace-header">
+                    <span>Prompt Context (Sent to DeepSeek-V3)</span>
+                    <span style={{ color: '#569cd6' }}>XML Protocol</span>
+                  </div>
+                  <div className="qc-llm-trace-content">
+                    {detail.llmTrace ? (
+                      <>
+                        <pre style={{ whiteSpace: 'pre-wrap', margin: 0 }}>
+                          {detail.llmTrace.promptSent}
+                        </pre>
+                        <div style={{ 
+                          marginTop: 24, 
+                          paddingTop: 16, 
+                          borderTop: '1px solid #333' 
+                        }}>
+                          <div style={{ color: '#6a9955', marginBottom: 8 }}>
+                            // LLM Output (Chain of Thought)
+                          </div>
+                          <pre style={{ 
+                            whiteSpace: 'pre-wrap', 
+                            margin: 0,
+                            color: '#9cdcfe',
+                            fontStyle: 'italic'
+                          }}>
+                            {detail.llmTrace.responseReceived}
+                          </pre>
+                          <div style={{ marginTop: 16, color: '#666' }}>
+                            Model: {detail.llmTrace.model} | 
+                            Latency: {detail.llmTrace.latencyMs}ms
+                          </div>
+                        </div>
+                      </>
+                    ) : (
+                      <div style={{ color: '#666', textAlign: 'center', padding: 40 }}>
+                        LLM Trace 数据不可用
+                        <br />
+                        <small>此功能需要在执行质控时启用 trace 模式</small>
+                      </div>
+                    )}
+                  </div>
+                </div>
+              )}
+            </div>
+          </div>
+        ) : (
+          <Empty description="暂无数据" style={{ padding: 40 }} />
+        )}
+      </Spin>
+    </Drawer>
+  );
+};
+
+export default QcDetailDrawer;
diff --git a/frontend-v2/src/modules/admin/components/qc-cockpit/QcReportDrawer.tsx b/frontend-v2/src/modules/admin/components/qc-cockpit/QcReportDrawer.tsx
new file mode 100644
index 00000000..962025d4
--- /dev/null
+++ b/frontend-v2/src/modules/admin/components/qc-cockpit/QcReportDrawer.tsx
@@ -0,0 +1,443 @@
+/**
+ * 质控报告抽屉组件
+ * 
+ * 功能：
+ * - 展示质控报告摘要
+ * - 展示严重问题和警告问题列表
+ * - 展示表单统计
+ * - 支持导出 XML 格式报告
+ */
+
+import React, { useState, useEffect } from 'react';
+import {
+  Drawer,
+  Tabs,
+  Statistic,
+  Row,
+  Col,
+  Card,
+  Table,
+  Tag,
+  Space,
+  Button,
+  Spin,
+  Empty,
+  Typography,
+  message,
+  Progress,
+  Tooltip,
+} from 'antd';
+import {
+  DownloadOutlined,
+  ReloadOutlined,
+  ExclamationCircleOutlined,
+  WarningOutlined,
+  CheckCircleOutlined,
+  FileTextOutlined,
+  BarChartOutlined,
+} from '@ant-design/icons';
+import type { QcReport } from '../../api/iitProjectApi';
+import * as iitProjectApi from '../../api/iitProjectApi';
+
+const { Text } = Typography;
+const { TabPane } = Tabs;
+
+interface QcReportDrawerProps {
+  open: boolean;
+  onClose: () => void;
+  projectId: string;
+  projectName: string;
+}
+
+const QcReportDrawer: React.FC<QcReportDrawerProps> = ({
+  open,
+  onClose,
+  projectId,
+  projectName,
+}) => {
+  const [loading, setLoading] = useState(false);
+  const [refreshing, setRefreshing] = useState(false);
+  const [report, setReport] = useState<QcReport | null>(null);
+
+  // 加载报告
+  const loadReport = async (forceRefresh = false) => {
+    if (forceRefresh) {
+      setRefreshing(true);
+    } else {
+      setLoading(true);
+    }
+
+    try {
+      let data: QcReport;
+      if (forceRefresh) {
+        data = await iitProjectApi.refreshQcReport(projectId);
+        message.success('报告已刷新');
+      } else {
+        data = await iitProjectApi.getQcReport(projectId, 'json') as QcReport;
+      }
+      setReport(data);
+    } catch (error: any) {
+      message.error(error.message || '加载报告失败');
+    } finally {
+      setLoading(false);
+      setRefreshing(false);
+    }
+  };
+
+  // 导出 XML 报告（导出前自动刷新，确保获取最新数据）
+  const handleExportXml = async () => {
+    try {
+      message.loading({ content: '正在生成最新报告...', key: 'export' });
+      
+      // 1. 先刷新报告（确保获取最新质控结果）
+      await iitProjectApi.refreshQcReport(projectId);
+      
+      // 2. 获取刷新后的 XML 报告
+      const xmlData = await iitProjectApi.getQcReport(projectId, 'xml') as string;
+      
+      // 3. 创建 Blob 并下载
+      const blob = new Blob([xmlData], { type: 'application/xml' });
+      const url = URL.createObjectURL(blob);
+      const link = document.createElement('a');
+      link.href = url;
+      const now = new Date();
+      const dateStr = now.toISOString().split('T')[0];
+      const timeStr = now.toTimeString().slice(0, 5).replace(':', '');  // HHMM 格式
+      link.download = `qc-report-${projectId}-${dateStr}-${timeStr}.xml`;
+      document.body.appendChild(link);
+      link.click();
+      document.body.removeChild(link);
+      URL.revokeObjectURL(url);
+      
+      message.success({ content: '报告已导出', key: 'export' });
+    } catch (error: any) {
+      message.error({ content: error.message || '导出失败', key: 'export' });
+    }
+  };
+
+  useEffect(() => {
+    if (open) {
+      loadReport();
+    }
+  }, [open, projectId]);
+
+  // 渲染摘要
+  const renderSummary = () => {
+    if (!report) return null;
+    const { summary } = report;
+
+    // V2.1: 防护空值
+    if (!summary) {
+      return (
+        <Empty
+          image={Empty.PRESENTED_IMAGE_SIMPLE}
+          description="暂无摘要数据，请尝试刷新报告"
+        />
+      );
+    }
+
+    // 安全获取数值
+    const totalRecords = summary.totalRecords ?? 0;
+    const passRate = summary.passRate ?? 0;
+    const criticalIssues = summary.criticalIssues ?? 0;
+    const warningIssues = summary.warningIssues ?? 0;
+    const completedRecords = summary.completedRecords ?? 0;
+
+    return (
+      <div className="qc-report-summary">
+        <Row gutter={[16, 16]}>
+          <Col span={6}>
+            <Card size="small">
+              <Statistic
+                title="总记录数"
+                value={totalRecords}
+                valueStyle={{ color: '#1890ff' }}
+              />
+            </Card>
+          </Col>
+          <Col span={6}>
+            <Card size="small">
+              <Statistic
+                title="通过率"
+                value={passRate}
+                suffix="%"
+                valueStyle={{ color: passRate >= 80 ? '#52c41a' : '#ff4d4f' }}
+              />
+            </Card>
+          </Col>
+          <Col span={6}>
+            <Card size="small">
+              <Statistic
+                title="严重问题"
+                value={criticalIssues}
+                valueStyle={{ color: '#ff4d4f' }}
+                prefix={<ExclamationCircleOutlined />}
+              />
+            </Card>
+          </Col>
+          <Col span={6}>
+            <Card size="small">
+              <Statistic
+                title="警告问题"
+                value={warningIssues}
+                valueStyle={{ color: '#faad14' }}
+                prefix={<WarningOutlined />}
+              />
+            </Card>
+          </Col>
+        </Row>
+
+        <Card size="small" style={{ marginTop: 16 }}>
+          <Row gutter={16}>
+            <Col span={12}>
+              <Text type="secondary">完成记录</Text>
+              <Progress
+                percent={totalRecords > 0 ? Math.round((completedRecords / totalRecords) * 100) : 0}
+                status="active"
+              />
+            </Col>
+            <Col span={12}>
+              <Text type="secondary">待确认</Text>
+              <Statistic value={summary.pendingQueries ?? 0} valueStyle={{ fontSize: 20 }} />
+            </Col>
+          </Row>
+        </Card>
+
+        <Card size="small" style={{ marginTop: 16 }}>
+          <Text type="secondary">报告生成时间: </Text>
+          <Text>{report.generatedAt ? new Date(report.generatedAt).toLocaleString() : '-'}</Text>
+          <br />
+          <Text type="secondary">最后质控时间: </Text>
+          <Text>{summary.lastQcTime ? new Date(summary.lastQcTime).toLocaleString() : '-'}</Text>
+        </Card>
+      </div>
+    );
+  };
+
+  // 渲染问题列表
+  const renderIssues = (issues: QcReport['criticalIssues'] | QcReport['warningIssues'], type: 'critical' | 'warning') => {
+    const columns = [
+      {
+        title: '记录 ID',
+        dataIndex: 'recordId',
+        key: 'recordId',
+        width: 100,
+        render: (text: string) => <Text code>{text}</Text>,
+      },
+      {
+        title: '规则',
+        dataIndex: 'ruleName',
+        key: 'ruleName',
+        width: 150,
+        ellipsis: true,
+      },
+      {
+        title: '问题描述',
+        dataIndex: 'message',
+        key: 'message',
+        ellipsis: true,
+        render: (text: string) => (
+          <Tooltip title={text}>
+            <span>{text}</span>
+          </Tooltip>
+        ),
+      },
+      {
+        title: '字段',
+        dataIndex: 'field',
+        key: 'field',
+        width: 120,
+        render: (text: string) => text ? <Text code>{text}</Text> : '-',
+      },
+      {
+        title: '检测时间',
+        dataIndex: 'detectedAt',
+        key: 'detectedAt',
+        width: 140,
+        render: (text: string) => text ? new Date(text).toLocaleDateString() : '-',
+      },
+    ];
+
+    return (
+      <Table
+        dataSource={issues}
+        columns={columns}
+        rowKey={(record, index) => `${record.recordId}-${record.ruleId}-${index}`}
+        size="small"
+        pagination={{ pageSize: 10 }}
+        locale={{
+          emptyText: (
+            <Empty
+              image={Empty.PRESENTED_IMAGE_SIMPLE}
+              description={type === 'critical' ? '无严重问题' : '无警告问题'}
+            />
+          ),
+        }}
+      />
+    );
+  };
+
+  // 渲染表单统计
+  const renderFormStats = () => {
+    if (!report?.formStats?.length) {
+      return <Empty description="暂无表单统计数据" />;
+    }
+
+    const columns = [
+      {
+        title: '表单',
+        dataIndex: 'formLabel',
+        key: 'formLabel',
+      },
+      {
+        title: '检查数',
+        dataIndex: 'totalChecks',
+        key: 'totalChecks',
+        width: 80,
+        align: 'center' as const,
+      },
+      {
+        title: '通过',
+        dataIndex: 'passed',
+        key: 'passed',
+        width: 80,
+        align: 'center' as const,
+        render: (text: number) => <Text type="success">{text}</Text>,
+      },
+      {
+        title: '失败',
+        dataIndex: 'failed',
+        key: 'failed',
+        width: 80,
+        align: 'center' as const,
+        render: (text: number) => <Text type="danger">{text}</Text>,
+      },
+      {
+        title: '通过率',
+        dataIndex: 'passRate',
+        key: 'passRate',
+        width: 120,
+        render: (rate: number) => (
+          <Progress
+            percent={rate}
+            size="small"
+            status={rate >= 80 ? 'success' : rate >= 60 ? 'normal' : 'exception'}
+          />
+        ),
+      },
+    ];
+
+    return (
+      <Table
+        dataSource={report?.formStats ?? []}
+        columns={columns}
+        rowKey="formName"
+        size="small"
+        pagination={false}
+      />
+    );
+  };
+
+  return (
+    <Drawer
+      title={
+        <Space>
+          <FileTextOutlined />
+          <span>质控报告 - {projectName}</span>
+        </Space>
+      }
+      placement="right"
+      width={800}
+      open={open}
+      onClose={onClose}
+      extra={
+        <Space>
+          <Button
+            icon={<ReloadOutlined spin={refreshing} />}
+            onClick={() => loadReport(true)}
+            loading={refreshing}
+          >
+            刷新报告
+          </Button>
+          <Button
+            type="primary"
+            icon={<DownloadOutlined />}
+            onClick={handleExportXml}
+          >
+            导出 XML
+          </Button>
+        </Space>
+      }
+    >
+      {loading ? (
+        <div style={{ textAlign: 'center', padding: 50 }}>
+          <Spin size="large" />
+          <div style={{ marginTop: 16 }}>
+            <Text type="secondary">正在生成报告...</Text>
+          </div>
+        </div>
+      ) : report ? (
+        <Tabs defaultActiveKey="summary">
+          <TabPane
+            tab={
+              <span>
+                <BarChartOutlined />
+                摘要
+              </span>
+            }
+            key="summary"
+          >
+            {renderSummary()}
+          </TabPane>
+          <TabPane
+            tab={
+              <span>
+                <ExclamationCircleOutlined style={{ color: '#ff4d4f' }} />
+                严重问题
+                {(report.criticalIssues?.length ?? 0) > 0 && (
+                  <Tag color="red" style={{ marginLeft: 8 }}>
+                    {report.criticalIssues?.length ?? 0}
+                  </Tag>
+                )}
+              </span>
+            }
+            key="critical"
+          >
+            {renderIssues(report.criticalIssues ?? [], 'critical')}
+          </TabPane>
+          <TabPane
+            tab={
+              <span>
+                <WarningOutlined style={{ color: '#faad14' }} />
+                警告问题
+                {(report.warningIssues?.length ?? 0) > 0 && (
+                  <Tag color="orange" style={{ marginLeft: 8 }}>
+                    {report.warningIssues?.length ?? 0}
+                  </Tag>
+                )}
+              </span>
+            }
+            key="warning"
+          >
+            {renderIssues(report.warningIssues ?? [], 'warning')}
+          </TabPane>
+          <TabPane
+            tab={
+              <span>
+                <CheckCircleOutlined />
+                表单统计
+              </span>
+            }
+            key="forms"
+          >
+            {renderFormStats()}
+          </TabPane>
+        </Tabs>
+      ) : (
+        <Empty description="暂无报告数据" />
+      )}
+    </Drawer>
+  );
+};
+
+export default QcReportDrawer;
diff --git a/frontend-v2/src/modules/admin/components/qc-cockpit/QcStatCards.tsx b/frontend-v2/src/modules/admin/components/qc-cockpit/QcStatCards.tsx
new file mode 100644
index 00000000..4d97989c
--- /dev/null
+++ b/frontend-v2/src/modules/admin/components/qc-cockpit/QcStatCards.tsx
@@ -0,0 +1,177 @@
+/**
+ * 质控统计卡片组件
+ * 
+ * 展示 4 个核心指标：
+ * - 总体数据质量分
+ * - 严重违规 (Critical) - 可点击查看详情
+ * - 待确认 Query (Major) - 可点击查看详情
+ * - 方案偏离 (PD) - 可点击查看详情
+ */
+
+import React from 'react';
+import { Progress, Tooltip } from 'antd';
+import {
+  HeartOutlined,
+  ExclamationCircleOutlined,
+  QuestionCircleOutlined,
+  ClockCircleOutlined,
+  RightOutlined,
+} from '@ant-design/icons';
+import type { QcStats } from '../../types/qcCockpit';
+
+// 卡片类型
+export type StatCardType = 'quality' | 'critical' | 'query' | 'deviation';
+
+interface QcStatCardsProps {
+  stats: QcStats;
+  onCardClick?: (type: StatCardType) => void;
+}
+
+const QcStatCards: React.FC<QcStatCardsProps> = ({ stats, onCardClick }) => {
+  // 判断卡片是否可点击
+  const isClickable = (type: StatCardType): boolean => {
+    switch (type) {
+      case 'critical': return stats.criticalCount > 0;
+      case 'query': return stats.queryCount > 0;
+      case 'deviation': return stats.deviationCount > 0;
+      default: return false;
+    }
+  };
+
+  const handleClick = (type: StatCardType) => {
+    if (isClickable(type) && onCardClick) {
+      onCardClick(type);
+    }
+  };
+
+  return (
+    <div className="qc-stat-cards">
+      {/* 卡片 1: 总体数据质量分 */}
+      <div className="qc-stat-card">
+        <div className="qc-stat-card-header">
+          <div className="qc-stat-card-content">
+            <div className="qc-stat-card-title">总体数据质量分</div>
+            <div className="qc-stat-card-value">
+              {stats.qualityScore}
+              <span className="qc-stat-card-suffix">/100</span>
+            </div>
+          </div>
+          <div className="qc-stat-card-icon success">
+            <HeartOutlined />
+          </div>
+        </div>
+        <div className="qc-stat-card-progress">
+          <Progress
+            percent={stats.qualityScore}
+            strokeColor={getScoreColor(stats.qualityScore)}
+            showInfo={false}
+            size="small"
+          />
+        </div>
+      </div>
+
+      {/* 卡片 2: 严重违规 (Critical) - 可点击 */}
+      <Tooltip title={stats.criticalCount > 0 ? '点击查看详情' : undefined}>
+        <div 
+          className={`qc-stat-card critical ${isClickable('critical') ? 'clickable' : ''}`}
+          onClick={() => handleClick('critical')}
+        >
+          <div className="qc-stat-card-header">
+            <div className="qc-stat-card-content">
+              <div className="qc-stat-card-title">严重违规 (Critical)</div>
+              <div className="qc-stat-card-value critical">
+                {stats.criticalCount}
+                <span className="qc-stat-card-suffix">条</span>
+              </div>
+            </div>
+            <div className="qc-stat-card-icon critical">
+              <ExclamationCircleOutlined />
+            </div>
+          </div>
+          <div className="qc-stat-card-footer">
+            <span className="qc-stat-card-desc">
+              {stats.criticalCount > 0 
+                ? `需立即处理：${getTopIssue(stats, 'critical')}` 
+                : '暂无严重违规'}
+            </span>
+            {stats.criticalCount > 0 && <RightOutlined className="qc-stat-card-arrow" />}
+          </div>
+        </div>
+      </Tooltip>
+
+      {/* 卡片 3: 待确认 Query (Major) - 可点击 */}
+      <Tooltip title={stats.queryCount > 0 ? '点击查看详情' : undefined}>
+        <div 
+          className={`qc-stat-card warning ${isClickable('query') ? 'clickable' : ''}`}
+          onClick={() => handleClick('query')}
+        >
+          <div className="qc-stat-card-header">
+            <div className="qc-stat-card-content">
+              <div className="qc-stat-card-title">待确认 Query (Major)</div>
+              <div className="qc-stat-card-value warning">
+                {stats.queryCount}
+                <span className="qc-stat-card-suffix">条</span>
+              </div>
+            </div>
+            <div className="qc-stat-card-icon warning">
+              <QuestionCircleOutlined />
+            </div>
+          </div>
+          <div className="qc-stat-card-footer">
+            <span className="qc-stat-card-desc">
+              {stats.queryCount > 0 
+                ? getTopIssue(stats, 'warning') 
+                : '暂无待确认问题'}
+            </span>
+            {stats.queryCount > 0 && <RightOutlined className="qc-stat-card-arrow" />}
+          </div>
+        </div>
+      </Tooltip>
+
+      {/* 卡片 4: 方案偏离 (PD) - 可点击 */}
+      <Tooltip title={stats.deviationCount > 0 ? '点击查看详情' : undefined}>
+        <div 
+          className={`qc-stat-card ${isClickable('deviation') ? 'clickable' : ''}`}
+          onClick={() => handleClick('deviation')}
+        >
+          <div className="qc-stat-card-header">
+            <div className="qc-stat-card-content">
+              <div className="qc-stat-card-title">方案偏离 (PD)</div>
+              <div className="qc-stat-card-value">
+                {stats.deviationCount}
+                <span className="qc-stat-card-suffix">条</span>
+              </div>
+            </div>
+            <div className="qc-stat-card-icon info">
+              <ClockCircleOutlined />
+            </div>
+          </div>
+          <div className="qc-stat-card-footer">
+            <span className="qc-stat-card-desc">
+              {stats.deviationCount > 0 
+                ? '大多为访视超窗' 
+                : '暂无方案偏离'}
+            </span>
+            {stats.deviationCount > 0 && <RightOutlined className="qc-stat-card-arrow" />}
+          </div>
+        </div>
+      </Tooltip>
+    </div>
+  );
+};
+
+// 根据分数获取颜色
+function getScoreColor(score: number): string {
+  if (score >= 90) return '#52c41a';
+  if (score >= 70) return '#faad14';
+  return '#ff4d4f';
+}
+
+// 获取顶部问题
+function getTopIssue(stats: QcStats, severity: 'critical' | 'warning'): string {
+  const issue = stats.topIssues?.find(i => i.severity === severity);
+  if (!issue) return '';
+  return `${issue.issue} (${issue.count})`;
+}
+
+export default QcStatCards;
diff --git a/frontend-v2/src/modules/admin/components/qc-cockpit/RiskHeatmap.tsx b/frontend-v2/src/modules/admin/components/qc-cockpit/RiskHeatmap.tsx
new file mode 100644
index 00000000..ce11077c
--- /dev/null
+++ b/frontend-v2/src/modules/admin/components/qc-cockpit/RiskHeatmap.tsx
@@ -0,0 +1,149 @@
+/**
+ * 风险热力图组件
+ * 
+ * 展示受试者 × 表单/访视 矩阵
+ * - 绿色圆点：通过
+ * - 黄色图标：警告（可点击）
+ * - 红色图标：严重（可点击）
+ * - 灰色圆点：未开始
+ */
+
+import React from 'react';
+import { Spin, Tag, Tooltip } from 'antd';
+import {
+  CheckOutlined,
+  ExclamationOutlined,
+  CloseOutlined,
+} from '@ant-design/icons';
+import type { HeatmapData, HeatmapCell } from '../../types/qcCockpit';
+
+interface RiskHeatmapProps {
+  data: HeatmapData;
+  onCellClick: (cell: HeatmapCell) => void;
+  loading?: boolean;
+}
+
+const RiskHeatmap: React.FC<RiskHeatmapProps> = ({ data, onCellClick, loading }) => {
+  const getStatusTag = (status: string) => {
+    switch (status) {
+      case 'enrolled':
+        return <Tag color="cyan">已入组</Tag>;
+      case 'screening':
+        return <Tag color="blue">筛查中</Tag>;
+      case 'completed':
+        return <Tag color="green">已完成</Tag>;
+      case 'withdrawn':
+        return <Tag color="default">已退出</Tag>;
+      default:
+        return <Tag>{status}</Tag>;
+    }
+  };
+
+  const renderCell = (cell: HeatmapCell) => {
+    const hasIssues = cell.status === 'warning' || cell.status === 'fail';
+    
+    // ✅ 所有单元格都可点击，便于查看详情
+    const handleClick = () => onCellClick(cell);
+    
+    // 有问题的单元格：显示可点击图标
+    if (hasIssues) {
+      const iconClass = `qc-heatmap-cell-icon ${cell.status}`;
+      const icon = cell.status === 'fail' 
+        ? <CloseOutlined />
+        : <ExclamationOutlined />;
+      
+      return (
+        <Tooltip title={`${cell.issueCount} 个问题，点击查看详情`}>
+          <div className={iconClass} onClick={handleClick} style={{ cursor: 'pointer' }}>
+            {icon}
+          </div>
+        </Tooltip>
+      );
+    }
+    
+    // 通过或待检查：显示小圆点（也可点击）
+    const dotClass = `qc-heatmap-cell-dot ${cell.status === 'pass' ? 'pass' : 'pending'}`;
+    const tooltipText = cell.status === 'pass' 
+      ? '已通过，点击查看数据' 
+      : '未质控，点击查看数据';
+    
+    return (
+      <Tooltip title={tooltipText}>
+        <div 
+          className={dotClass} 
+          onClick={handleClick}
+          style={{ 
+            backgroundColor: cell.status === 'pass' ? '#52c41a' : '#d9d9d9',
+            cursor: 'pointer',
+          }} 
+        />
+      </Tooltip>
+    );
+  };
+
+  return (
+    <div className="qc-heatmap">
+      {/* 头部 */}
+      <div className="qc-heatmap-header">
+        <h3 className="qc-heatmap-title">受试者风险全景图 (Risk Heatmap)</h3>
+        <div className="qc-heatmap-legend">
+          <span className="qc-heatmap-legend-item">
+            <span className="qc-heatmap-legend-dot pass" />
+            无异常
+          </span>
+          <span className="qc-heatmap-legend-item">
+            <span className="qc-heatmap-legend-dot warning" />
+            疑问 (Query)
+          </span>
+          <span className="qc-heatmap-legend-item">
+            <span className="qc-heatmap-legend-dot fail" />
+            严重违规
+          </span>
+          <span className="qc-heatmap-legend-item">
+            <span className="qc-heatmap-legend-dot pending" />
+            未开始
+          </span>
+        </div>
+      </div>
+
+      {/* 表格内容 */}
+      <div className="qc-heatmap-body">
+        <Spin spinning={loading}>
+          <table className="qc-heatmap-table">
+            <thead>
+              <tr>
+                <th className="subject-header">受试者 ID</th>
+                <th>入组状态</th>
+                {data.columns.map((col, idx) => (
+                  <th key={idx}>
+                    {col.split('(')[0]}<br />
+                    <small style={{ fontWeight: 'normal' }}>
+                      {col.includes('(') ? `(${col.split('(')[1]}` : ''}
+                    </small>
+                  </th>
+                ))}
+              </tr>
+            </thead>
+            <tbody>
+              {data.rows.map((row, rowIdx) => (
+                <tr key={rowIdx}>
+                  <td className="subject-cell">{row.recordId}</td>
+                  <td>{getStatusTag(row.status)}</td>
+                  {row.cells.map((cell, cellIdx) => (
+                    <td key={cellIdx}>
+                      <div className="qc-heatmap-cell">
+                        {renderCell(cell)}
+                      </div>
+                    </td>
+                  ))}
+                </tr>
+              ))}
+            </tbody>
+          </table>
+        </Spin>
+      </div>
+    </div>
+  );
+};
+
+export default RiskHeatmap;
diff --git a/frontend-v2/src/modules/admin/components/qc-cockpit/index.ts b/frontend-v2/src/modules/admin/components/qc-cockpit/index.ts
new file mode 100644
index 00000000..1c4e0211
--- /dev/null
+++ b/frontend-v2/src/modules/admin/components/qc-cockpit/index.ts
@@ -0,0 +1,8 @@
+/**
+ * 质控驾驶舱组件导出
+ */
+
+export { default as QcStatCards } from './QcStatCards';
+export type { StatCardType } from './QcStatCards';
+export { default as RiskHeatmap } from './RiskHeatmap';
+export { default as QcDetailDrawer } from './QcDetailDrawer';
diff --git a/frontend-v2/src/modules/admin/index.tsx b/frontend-v2/src/modules/admin/index.tsx
index a21df7d8..46776355 100644
--- a/frontend-v2/src/modules/admin/index.tsx
+++ b/frontend-v2/src/modules/admin/index.tsx
@@ -20,6 +20,7 @@ import SystemKbListPage from './pages/SystemKbListPage';
 import SystemKbDetailPage from './pages/SystemKbDetailPage';
 import IitProjectListPage from './pages/IitProjectListPage';
 import IitProjectDetailPage from './pages/IitProjectDetailPage';
+import IitQcCockpitPage from './pages/IitQcCockpitPage';
 
 const AdminModule: React.FC = () => {
   return (
@@ -42,6 +43,7 @@ const AdminModule: React.FC = () => {
       {/* IIT 项目管理 */}
       <Route path="iit-projects" element={<IitProjectListPage />} />
       <Route path="iit-projects/:id" element={<IitProjectDetailPage />} />
+      <Route path="iit-projects/:id/cockpit" element={<IitQcCockpitPage />} />
     </Routes>
   );
 };
diff --git a/frontend-v2/src/modules/admin/pages/IitProjectDetailPage.tsx b/frontend-v2/src/modules/admin/pages/IitProjectDetailPage.tsx
index bfc57a87..fa02453a 100644
--- a/frontend-v2/src/modules/admin/pages/IitProjectDetailPage.tsx
+++ b/frontend-v2/src/modules/admin/pages/IitProjectDetailPage.tsx
@@ -42,6 +42,7 @@ import {
   BookOutlined,
   ThunderboltOutlined,
   BarChartOutlined,
+  DashboardOutlined,
 } from '@ant-design/icons';
 import * as iitProjectApi from '../api/iitProjectApi';
 import type {
@@ -183,8 +184,16 @@ const IitProjectDetailPage: React.FC = () => {
           </Space>
           {/* ⭐ 批量操作按钮 */}
           <Space>
+            {/* ⭐ 质控全览图按钮 - 导航到驾驶舱页面 */}
             <Button
               type="primary"
+              icon={<DashboardOutlined />}
+              onClick={() => navigate(`/admin/iit-projects/${id}/cockpit`)}
+              style={{ background: '#722ed1' }}
+            >
+              质控全览图
+            </Button>
+            <Button
               icon={<ThunderboltOutlined />}
               loading={batchQcLoading}
               onClick={handleBatchQc}
diff --git a/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.css b/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.css
new file mode 100644
index 00000000..11939c40
--- /dev/null
+++ b/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.css
@@ -0,0 +1,680 @@
+/**
+ * 质控驾驶舱页面样式
+ */
+
+.qc-cockpit {
+  display: flex;
+  flex-direction: column;
+  min-height: 100vh;
+  background: #f5f7fa;
+}
+
+.qc-cockpit-fullscreen {
+  position: fixed;
+  top: 0;
+  left: 0;
+  right: 0;
+  bottom: 0;
+  z-index: 1000;
+}
+
+/* 加载状态 */
+.qc-cockpit-loading,
+.qc-cockpit-empty {
+  display: flex;
+  flex-direction: column;
+  justify-content: center;
+  align-items: center;
+  min-height: 400px;
+}
+
+/* 顶部导航栏 */
+.qc-cockpit-header {
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+  padding: 16px 24px;
+  background: #fff;
+  border-bottom: 1px solid #e8e8e8;
+  flex-shrink: 0;
+}
+
+.qc-cockpit-header-left {
+  display: flex;
+  align-items: center;
+  gap: 16px;
+}
+
+.qc-cockpit-title {
+  display: flex;
+  flex-direction: column;
+  gap: 2px;
+}
+
+.qc-cockpit-header-right {
+  display: flex;
+  align-items: center;
+}
+
+/* 主内容区 */
+.qc-cockpit-content {
+  flex: 1;
+  padding: 24px;
+  overflow-y: auto;
+  display: flex;
+  flex-direction: column;
+  gap: 24px;
+}
+
+/* 统计卡片容器 */
+.qc-stat-cards {
+  display: grid;
+  grid-template-columns: repeat(4, 1fr);
+  gap: 16px;
+}
+
+@media (max-width: 1200px) {
+  .qc-stat-cards {
+    grid-template-columns: repeat(2, 1fr);
+  }
+}
+
+@media (max-width: 768px) {
+  .qc-stat-cards {
+    grid-template-columns: 1fr;
+  }
+}
+
+/* 单个统计卡片 */
+.qc-stat-card {
+  background: #fff;
+  border-radius: 12px;
+  padding: 20px;
+  border: 1px solid #e8e8e8;
+  box-shadow: 0 1px 3px rgba(0, 0, 0, 0.05);
+  transition: box-shadow 0.2s;
+}
+
+.qc-stat-card:hover {
+  box-shadow: 0 4px 12px rgba(0, 0, 0, 0.1);
+}
+
+/* 可点击的卡片样式 */
+.qc-stat-card.clickable {
+  cursor: pointer;
+}
+
+.qc-stat-card.clickable:hover {
+  box-shadow: 0 4px 16px rgba(0, 0, 0, 0.15);
+  transform: translateY(-2px);
+}
+
+.qc-stat-card.clickable:active {
+  transform: translateY(0);
+}
+
+.qc-stat-card-footer {
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+}
+
+.qc-stat-card-arrow {
+  color: #999;
+  font-size: 12px;
+  transition: transform 0.2s;
+}
+
+.qc-stat-card.clickable:hover .qc-stat-card-arrow {
+  transform: translateX(4px);
+  color: #1890ff;
+}
+
+.qc-stat-card.critical {
+  border-left: 4px solid #ff4d4f;
+}
+
+.qc-stat-card.warning {
+  border-left: 4px solid #faad14;
+}
+
+.qc-stat-card.success {
+  border-left: 4px solid #52c41a;
+}
+
+.qc-stat-card-header {
+  display: flex;
+  justify-content: space-between;
+  align-items: flex-start;
+}
+
+.qc-stat-card-content {
+  flex: 1;
+}
+
+.qc-stat-card-title {
+  font-size: 14px;
+  color: #666;
+  margin-bottom: 8px;
+}
+
+.qc-stat-card-value {
+  font-size: 32px;
+  font-weight: 700;
+  line-height: 1.2;
+}
+
+.qc-stat-card-value.critical {
+  color: #ff4d4f;
+}
+
+.qc-stat-card-value.warning {
+  color: #faad14;
+}
+
+.qc-stat-card-value.success {
+  color: #52c41a;
+}
+
+.qc-stat-card-suffix {
+  font-size: 14px;
+  font-weight: 400;
+  color: #999;
+  margin-left: 4px;
+}
+
+.qc-stat-card-icon {
+  width: 40px;
+  height: 40px;
+  border-radius: 8px;
+  display: flex;
+  align-items: center;
+  justify-content: center;
+  font-size: 18px;
+}
+
+.qc-stat-card-icon.critical {
+  background: #fff1f0;
+  color: #ff4d4f;
+}
+
+.qc-stat-card-icon.warning {
+  background: #fffbe6;
+  color: #faad14;
+}
+
+.qc-stat-card-icon.success {
+  background: #f6ffed;
+  color: #52c41a;
+}
+
+.qc-stat-card-icon.info {
+  background: #e6f7ff;
+  color: #1890ff;
+}
+
+.qc-stat-card-footer {
+  margin-top: 12px;
+  padding-top: 12px;
+  border-top: 1px solid #f0f0f0;
+}
+
+.qc-stat-card-desc {
+  font-size: 12px;
+  color: #999;
+}
+
+.qc-stat-card-progress {
+  margin-top: 12px;
+}
+
+/* 热力图容器 */
+.qc-heatmap {
+  background: #fff;
+  border-radius: 12px;
+  border: 1px solid #e8e8e8;
+  box-shadow: 0 1px 3px rgba(0, 0, 0, 0.05);
+  overflow: hidden;
+  flex: 1;
+  min-height: 400px;
+}
+
+.qc-heatmap-header {
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+  padding: 16px 20px;
+  background: #fafafa;
+  border-bottom: 1px solid #e8e8e8;
+}
+
+.qc-heatmap-title {
+  font-size: 16px;
+  font-weight: 600;
+  color: #333;
+}
+
+.qc-heatmap-legend {
+  display: flex;
+  align-items: center;
+  gap: 16px;
+  font-size: 12px;
+  color: #666;
+}
+
+.qc-heatmap-legend-item {
+  display: flex;
+  align-items: center;
+  gap: 4px;
+}
+
+.qc-heatmap-legend-dot {
+  width: 12px;
+  height: 12px;
+  border-radius: 50%;
+}
+
+.qc-heatmap-legend-dot.pass {
+  background: #52c41a;
+}
+
+.qc-heatmap-legend-dot.warning {
+  background: #faad14;
+}
+
+.qc-heatmap-legend-dot.fail {
+  background: #ff4d4f;
+}
+
+.qc-heatmap-legend-dot.pending {
+  background: #d9d9d9;
+}
+
+.qc-heatmap-body {
+  overflow-x: auto;
+}
+
+.qc-heatmap-table {
+  width: 100%;
+  border-collapse: collapse;
+  font-size: 14px;
+}
+
+.qc-heatmap-table th,
+.qc-heatmap-table td {
+  padding: 12px 16px;
+  text-align: center;
+  border-bottom: 1px solid #f0f0f0;
+}
+
+.qc-heatmap-table th {
+  background: #fafafa;
+  font-weight: 500;
+  color: #666;
+  font-size: 12px;
+  text-transform: uppercase;
+}
+
+.qc-heatmap-table th.subject-header {
+  text-align: left;
+  min-width: 120px;
+}
+
+.qc-heatmap-table td.subject-cell {
+  text-align: left;
+  font-weight: 500;
+}
+
+.qc-heatmap-table tr:hover {
+  background: #fafafa;
+}
+
+/* 热力图单元格 */
+.qc-heatmap-cell {
+  display: flex;
+  justify-content: center;
+  align-items: center;
+}
+
+.qc-heatmap-cell-dot {
+  width: 12px;
+  height: 12px;
+  border-radius: 50%;
+  cursor: default;
+}
+
+.qc-heatmap-cell-icon {
+  width: 32px;
+  height: 32px;
+  border-radius: 8px;
+  display: flex;
+  align-items: center;
+  justify-content: center;
+  cursor: pointer;
+  transition: transform 0.15s, box-shadow 0.15s;
+  font-size: 14px;
+  color: #fff;
+}
+
+.qc-heatmap-cell-icon:hover {
+  transform: scale(1.1);
+  box-shadow: 0 2px 8px rgba(0, 0, 0, 0.2);
+}
+
+.qc-heatmap-cell-icon.pass {
+  background: #52c41a;
+}
+
+.qc-heatmap-cell-icon.warning {
+  background: #faad14;
+}
+
+.qc-heatmap-cell-icon.fail {
+  background: #ff4d4f;
+}
+
+.qc-heatmap-cell-icon.pending {
+  background: #d9d9d9;
+}
+
+/* 状态标签 */
+.qc-status-tag {
+  padding: 2px 8px;
+  border-radius: 10px;
+  font-size: 12px;
+}
+
+.qc-status-tag.enrolled {
+  background: #e6fffb;
+  color: #13c2c2;
+}
+
+.qc-status-tag.screening {
+  background: #e6f7ff;
+  color: #1890ff;
+}
+
+.qc-status-tag.completed {
+  background: #f6ffed;
+  color: #52c41a;
+}
+
+/* 抽屉样式 */
+.qc-drawer-header {
+  display: flex;
+  align-items: center;
+  gap: 16px;
+}
+
+.qc-drawer-avatar {
+  width: 48px;
+  height: 48px;
+  border-radius: 50%;
+  background: #e6f7ff;
+  color: #1890ff;
+  display: flex;
+  align-items: center;
+  justify-content: center;
+  font-size: 18px;
+  font-weight: 600;
+}
+
+.qc-drawer-info {
+  flex: 1;
+}
+
+.qc-drawer-title {
+  font-size: 18px;
+  font-weight: 600;
+  margin-bottom: 4px;
+}
+
+.qc-drawer-subtitle {
+  font-size: 12px;
+  color: #999;
+}
+
+.qc-drawer-content {
+  display: flex;
+  height: calc(100vh - 120px);
+}
+
+.qc-drawer-left {
+  flex: 1;
+  border-right: 1px solid #f0f0f0;
+  overflow-y: auto;
+  padding: 16px;
+  background: #fff;
+}
+
+.qc-drawer-right {
+  flex: 1;
+  overflow-y: auto;
+  background: #fafafa;
+}
+
+.qc-drawer-section {
+  padding: 16px;
+  border-bottom: 1px solid #f0f0f0;
+}
+
+.qc-drawer-section-title {
+  font-size: 14px;
+  font-weight: 600;
+  color: #333;
+  margin-bottom: 12px;
+  display: flex;
+  align-items: center;
+  gap: 8px;
+}
+
+/* 数据字段展示 */
+.qc-field-list {
+  display: flex;
+  flex-direction: column;
+  gap: 12px;
+}
+
+.qc-field-item {
+  display: flex;
+  flex-direction: column;
+  gap: 4px;
+}
+
+.qc-field-label {
+  font-size: 12px;
+  color: #999;
+  text-transform: uppercase;
+}
+
+.qc-field-value {
+  padding: 8px 12px;
+  background: #f5f5f5;
+  border-radius: 6px;
+  font-size: 14px;
+  border: 1px solid #e8e8e8;
+}
+
+.qc-field-value.error {
+  background: #fff1f0;
+  border-color: #ffccc7;
+  color: #cf1322;
+  font-weight: 500;
+}
+
+.qc-field-value.warning {
+  background: #fffbe6;
+  border-color: #ffe58f;
+  color: #d48806;
+}
+
+/* 问题卡片 */
+.qc-issue-card {
+  background: #fff;
+  border-radius: 8px;
+  border: 1px solid #e8e8e8;
+  overflow: hidden;
+  margin-bottom: 12px;
+}
+
+.qc-issue-card.critical {
+  border-color: #ffccc7;
+}
+
+.qc-issue-card.warning {
+  border-color: #ffe58f;
+}
+
+.qc-issue-card-header {
+  padding: 12px 16px;
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+}
+
+.qc-issue-card-header.critical {
+  background: #fff1f0;
+}
+
+.qc-issue-card-header.warning {
+  background: #fffbe6;
+}
+
+.qc-issue-card-title {
+  display: flex;
+  align-items: center;
+  gap: 8px;
+  font-weight: 600;
+}
+
+.qc-issue-card-title.critical {
+  color: #cf1322;
+}
+
+.qc-issue-card-title.warning {
+  color: #d48806;
+}
+
+.qc-issue-card-confidence {
+  font-size: 12px;
+  padding: 2px 8px;
+  border-radius: 4px;
+  background: #fff;
+  border: 1px solid currentColor;
+}
+
+.qc-issue-card-body {
+  padding: 16px;
+}
+
+.qc-issue-card-description {
+  font-size: 14px;
+  color: #333;
+  line-height: 1.6;
+}
+
+.qc-issue-card-evidence {
+  margin-top: 12px;
+  padding: 12px;
+  background: #f5f5f5;
+  border-radius: 6px;
+  font-size: 12px;
+  color: #666;
+}
+
+.qc-issue-card-footer {
+  padding: 12px 16px;
+  border-top: 1px solid #f0f0f0;
+  display: flex;
+  gap: 8px;
+}
+
+/* Tab 切换 */
+.qc-drawer-tabs {
+  display: flex;
+  border-bottom: 1px solid #e8e8e8;
+  background: #fff;
+}
+
+.qc-drawer-tab {
+  flex: 1;
+  padding: 16px;
+  text-align: center;
+  cursor: pointer;
+  border-bottom: 2px solid transparent;
+  font-size: 14px;
+  font-weight: 500;
+  color: #666;
+  transition: all 0.2s;
+}
+
+.qc-drawer-tab:hover {
+  color: #1890ff;
+}
+
+.qc-drawer-tab.active {
+  color: #1890ff;
+  border-bottom-color: #1890ff;
+}
+
+/* LLM Trace 样式 */
+.qc-llm-trace {
+  background: #1e1e1e;
+  color: #d4d4d4;
+  font-family: 'Monaco', 'Menlo', 'Ubuntu Mono', monospace;
+  font-size: 12px;
+  padding: 16px;
+  min-height: 100%;
+}
+
+.qc-llm-trace-header {
+  padding: 12px 16px;
+  background: #252526;
+  color: #999;
+  display: flex;
+  justify-content: space-between;
+  border-bottom: 1px solid #333;
+}
+
+.qc-llm-trace-content {
+  padding: 16px;
+  line-height: 1.6;
+}
+
+.xml-tag {
+  color: #569cd6;
+}
+
+.xml-attr {
+  color: #9cdcfe;
+}
+
+.xml-value {
+  color: #ce9178;
+}
+
+.xml-content {
+  color: #d4d4d4;
+}
+
+.xml-comment {
+  color: #6a9955;
+}
+
+/* 响应式 */
+@media (max-width: 1024px) {
+  .qc-drawer-content {
+    flex-direction: column;
+  }
+  
+  .qc-drawer-left,
+  .qc-drawer-right {
+    flex: none;
+    border-right: none;
+  }
+  
+  .qc-drawer-left {
+    border-bottom: 1px solid #f0f0f0;
+    max-height: 50%;
+  }
+}
diff --git a/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.tsx b/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.tsx
new file mode 100644
index 00000000..58cb4340
--- /dev/null
+++ b/frontend-v2/src/modules/admin/pages/IitQcCockpitPage.tsx
@@ -0,0 +1,297 @@
+/**
+ * IIT 质控驾驶舱页面 (QC Cockpit)
+ * 
+ * 功能：
+ * - 可视化质控全景图
+ * - 统计卡片展示关键指标（可点击查看详情）
+ * - 风险热力图（受试者 × 表单/访视 矩阵）
+ * - 点击单元格查看详情（侧滑抽屉）
+ * 
+ * @see docs/03-业务模块/IIT Manager Agent/01-需求分析/质控管理原型图.html
+ */
+
+import React, { useState, useEffect, useCallback } from 'react';
+import { useParams, useNavigate } from 'react-router-dom';
+import {
+  Button,
+  Space,
+  Spin,
+  Empty,
+  message,
+  Typography,
+  Tooltip,
+  Modal,
+  Table,
+  Tag,
+} from 'antd';
+import {
+  ArrowLeftOutlined,
+  FileExcelOutlined,
+  FullscreenOutlined,
+  FullscreenExitOutlined,
+  ExclamationCircleOutlined,
+  WarningOutlined,
+} from '@ant-design/icons';
+import QcStatCards from '../components/qc-cockpit/QcStatCards';
+import type { StatCardType } from '../components/qc-cockpit/QcStatCards';
+import RiskHeatmap from '../components/qc-cockpit/RiskHeatmap';
+import QcDetailDrawer from '../components/qc-cockpit/QcDetailDrawer';
+import QcReportDrawer from '../components/qc-cockpit/QcReportDrawer';
+import * as iitProjectApi from '../api/iitProjectApi';
+import type { IitProject } from '../types/iitProject';
+import type { QcCockpitData, HeatmapCell } from '../types/qcCockpit';
+import './IitQcCockpitPage.css';
+
+const { Title, Text } = Typography;
+
+const IitQcCockpitPage: React.FC = () => {
+  const { id } = useParams<{ id: string }>();
+  const navigate = useNavigate();
+
+  // 状态
+  const [project, setProject] = useState<IitProject | null>(null);
+  const [cockpitData, setCockpitData] = useState<QcCockpitData | null>(null);
+  const [loading, setLoading] = useState(true);
+  const [refreshing, setRefreshing] = useState(false);
+  const [fullscreen, setFullscreen] = useState(false);
+  
+  // 抽屉状态
+  const [drawerOpen, setDrawerOpen] = useState(false);
+  const [selectedCell, setSelectedCell] = useState<HeatmapCell | null>(null);
+  
+  // 问题列表模态框状态
+  const [issueModalOpen, setIssueModalOpen] = useState(false);
+  const [issueModalType, setIssueModalType] = useState<StatCardType | null>(null);
+  
+  // 报告抽屉状态
+  const [reportDrawerOpen, setReportDrawerOpen] = useState(false);
+
+  // 加载项目信息和质控数据
+  const loadData = useCallback(async (showLoading = true) => {
+    if (!id) return;
+    
+    if (showLoading) setLoading(true);
+    else setRefreshing(true);
+    
+    try {
+      // 并行加载项目信息和驾驶舱数据
+      const [projectData, cockpitResponse] = await Promise.all([
+        iitProjectApi.getProject(id),
+        iitProjectApi.getQcCockpitData(id),
+      ]);
+      
+      setProject(projectData);
+      setCockpitData(cockpitResponse);
+    } catch (error: any) {
+      message.error(error.message || '加载数据失败');
+    } finally {
+      setLoading(false);
+      setRefreshing(false);
+    }
+  }, [id]);
+
+  useEffect(() => {
+    loadData();
+  }, [loadData]);
+
+  // 处理热力图单元格点击
+  const handleCellClick = (cell: HeatmapCell) => {
+    setSelectedCell(cell);
+    setDrawerOpen(true);
+  };
+
+  // 处理统计卡片点击
+  const handleStatCardClick = (type: StatCardType) => {
+    setIssueModalType(type);
+    setIssueModalOpen(true);
+  };
+
+  // 获取问题列表模态框标题
+  const getIssueModalTitle = (): string => {
+    switch (issueModalType) {
+      case 'critical': return '严重违规问题列表';
+      case 'query': return '待确认问题列表';
+      case 'deviation': return '方案偏离列表';
+      default: return '问题列表';
+    }
+  };
+
+  // 获取问题列表数据
+  const getIssueListData = () => {
+    if (!cockpitData?.stats.topIssues) return [];
+    
+    type TopIssue = { issue: string; count: number; severity: 'critical' | 'warning' | 'info' };
+    
+    switch (issueModalType) {
+      case 'critical':
+        return cockpitData.stats.topIssues.filter((i: TopIssue) => i.severity === 'critical');
+      case 'query':
+        return cockpitData.stats.topIssues.filter((i: TopIssue) => i.severity === 'warning');
+      default:
+        return cockpitData.stats.topIssues;
+    }
+  };
+
+  // 打开报告抽屉
+  const handleViewReport = () => {
+    setReportDrawerOpen(true);
+  };
+
+  // 切换全屏
+  const toggleFullscreen = () => {
+    setFullscreen(!fullscreen);
+  };
+
+  if (loading) {
+    return (
+      <div className="qc-cockpit-loading">
+        <Spin size="large" />
+        <Text type="secondary" style={{ marginTop: 16 }}>加载质控数据中...</Text>
+      </div>
+    );
+  }
+
+  if (!project || !cockpitData) {
+    return (
+      <div className="qc-cockpit-empty">
+        <Empty description="项目不存在或暂无质控数据">
+          <Button onClick={() => navigate('/admin/iit-projects')}>返回列表</Button>
+        </Empty>
+      </div>
+    );
+  }
+
+  return (
+    <div className={`qc-cockpit ${fullscreen ? 'qc-cockpit-fullscreen' : ''}`}>
+      {/* 顶部导航栏 */}
+      <header className="qc-cockpit-header">
+        <div className="qc-cockpit-header-left">
+          <Button
+            icon={<ArrowLeftOutlined />}
+            onClick={() => navigate(`/admin/iit-projects/${id}`)}
+          >
+            返回配置
+          </Button>
+          <div className="qc-cockpit-title">
+            <Title level={4} style={{ margin: 0 }}>CRA 智能监查驾驶舱</Title>
+            <Text type="secondary">
+              项目: {project.name} | 最后同步: {
+                project.lastSyncAt 
+                  ? new Date(project.lastSyncAt).toLocaleString() 
+                  : '从未同步'
+              }
+            </Text>
+          </div>
+        </div>
+        <div className="qc-cockpit-header-right">
+          <Space>
+            <Button
+              type="primary"
+              icon={<FileExcelOutlined />}
+              onClick={handleViewReport}
+            >
+              查看质控报告
+            </Button>
+            <Tooltip title={fullscreen ? '退出全屏' : '全屏模式'}>
+              <Button
+                icon={fullscreen ? <FullscreenExitOutlined /> : <FullscreenOutlined />}
+                onClick={toggleFullscreen}
+              />
+            </Tooltip>
+          </Space>
+        </div>
+      </header>
+
+      {/* 主内容区 */}
+      <main className="qc-cockpit-content">
+        {/* 统计卡片 - 可点击查看详情 */}
+        <QcStatCards 
+          stats={cockpitData.stats} 
+          onCardClick={handleStatCardClick}
+        />
+
+        {/* 风险热力图 */}
+        <RiskHeatmap
+          data={cockpitData.heatmap}
+          onCellClick={handleCellClick}
+          loading={refreshing}
+        />
+      </main>
+
+      {/* 详情抽屉 */}
+      <QcDetailDrawer
+        open={drawerOpen}
+        onClose={() => setDrawerOpen(false)}
+        cell={selectedCell}
+        projectId={id!}
+        projectName={project.name}
+      />
+
+      {/* 报告抽屉 */}
+      <QcReportDrawer
+        open={reportDrawerOpen}
+        onClose={() => setReportDrawerOpen(false)}
+        projectId={id!}
+        projectName={project.name}
+      />
+
+      {/* 问题列表模态框 */}
+      <Modal
+        title={getIssueModalTitle()}
+        open={issueModalOpen}
+        onCancel={() => setIssueModalOpen(false)}
+        footer={null}
+        width={700}
+      >
+        <Table
+          dataSource={getIssueListData()}
+          rowKey="issue"
+          pagination={false}
+          columns={[
+            {
+              title: '问题描述',
+              dataIndex: 'issue',
+              key: 'issue',
+              render: (text: string, record: any) => (
+                <Space>
+                  {record.severity === 'critical' ? (
+                    <ExclamationCircleOutlined style={{ color: '#ff4d4f' }} />
+                  ) : (
+                    <WarningOutlined style={{ color: '#faad14' }} />
+                  )}
+                  <span>{text}</span>
+                </Space>
+              ),
+            },
+            {
+              title: '数量',
+              dataIndex: 'count',
+              key: 'count',
+              width: 80,
+              align: 'center' as const,
+              render: (count: number) => (
+                <Tag color={count > 10 ? 'red' : count > 5 ? 'orange' : 'default'}>
+                  {count}
+                </Tag>
+              ),
+            },
+            {
+              title: '严重程度',
+              dataIndex: 'severity',
+              key: 'severity',
+              width: 100,
+              render: (severity: string) => (
+                <Tag color={severity === 'critical' ? 'red' : 'orange'}>
+                  {severity === 'critical' ? '严重' : '警告'}
+                </Tag>
+              ),
+            },
+          ]}
+          locale={{ emptyText: '暂无问题' }}
+        />
+      </Modal>
+    </div>
+  );
+};
+
+export default IitQcCockpitPage;
diff --git a/frontend-v2/src/modules/admin/types/qcCockpit.ts b/frontend-v2/src/modules/admin/types/qcCockpit.ts
new file mode 100644
index 00000000..49e3d2d0
--- /dev/null
+++ b/frontend-v2/src/modules/admin/types/qcCockpit.ts
@@ -0,0 +1,116 @@
+/**
+ * 质控驾驶舱相关类型定义
+ */
+
+// 统计数据
+export interface QcStats {
+  /** 总体数据质量分 (0-100) */
+  qualityScore: number;
+  /** 总记录数 */
+  totalRecords: number;
+  /** 通过记录数 */
+  passedRecords: number;
+  /** 失败记录数 */
+  failedRecords: number;
+  /** 警告记录数 */
+  warningRecords: number;
+  /** 待检查记录数 */
+  pendingRecords: number;
+  /** 严重违规数（Critical） */
+  criticalCount: number;
+  /** 待确认 Query 数（Major） */
+  queryCount: number;
+  /** 方案偏离数（PD） */
+  deviationCount: number;
+  /** 通过率 */
+  passRate: number;
+  /** 主要问题 */
+  topIssues?: Array<{
+    issue: string;
+    count: number;
+    severity: 'critical' | 'warning' | 'info';
+  }>;
+}
+
+// 热力图数据
+export interface HeatmapData {
+  /** 行标题（表单/访视名称） */
+  columns: string[];
+  /** 行数据 */
+  rows: HeatmapRow[];
+}
+
+export interface HeatmapRow {
+  /** 受试者 ID */
+  recordId: string;
+  /** 入组状态 */
+  status: 'enrolled' | 'screening' | 'completed' | 'withdrawn';
+  /** 各表单/访视的质控状态 */
+  cells: HeatmapCell[];
+}
+
+export interface HeatmapCell {
+  /** 表单/访视名称 */
+  formName: string;
+  /** 质控状态 */
+  status: 'pass' | 'warning' | 'fail' | 'pending';
+  /** 问题数量 */
+  issueCount: number;
+  /** 受试者 ID（冗余，方便查询） */
+  recordId: string;
+  /** 问题摘要 */
+  issues?: Array<{
+    field: string;
+    message: string;
+    severity: 'critical' | 'warning' | 'info';
+  }>;
+}
+
+// 完整的驾驶舱数据
+export interface QcCockpitData {
+  /** 统计数据 */
+  stats: QcStats;
+  /** 热力图数据 */
+  heatmap: HeatmapData;
+  /** 最后更新时间 */
+  lastUpdatedAt: string;
+}
+
+// 记录详情
+export interface RecordDetail {
+  recordId: string;
+  formName: string;
+  status: 'pass' | 'warning' | 'fail' | 'pending';
+  /** 表单数据 */
+  data: Record<string, any>;
+  /** 字段元数据 */
+  fieldMetadata?: Record<string, {
+    label: string;
+    type: string;
+    normalRange?: { min?: number; max?: number };
+  }>;
+  /** 质控问题 */
+  issues: Array<{
+    field: string;
+    ruleName: string;
+    message: string;
+    severity: 'critical' | 'warning' | 'info';
+    actualValue?: any;
+    expectedValue?: string;
+    confidence?: 'high' | 'medium' | 'low';
+  }>;
+  /** LLM Trace（调试用） */
+  llmTrace?: {
+    promptSent: string;
+    responseReceived: string;
+    model: string;
+    latencyMs: number;
+  };
+  /** 录入时间 */
+  entryTime?: string;
+}
+
+// API 响应类型
+export interface QcCockpitResponse extends QcCockpitData {}
+
+export interface RecordDetailResponse extends RecordDetail {}