Spaces:

maomaobj
/

detail1

Running

App Files Files Community

maomaobj commited on Jun 13, 2025

Commit

57e7783

verified ·

1 Parent(s): 9aa0426

请为我设计一个专业、结构化、模块清晰的知识页面，主题为 “稽查应对支持”，用于展示临床试验中应对药监局或申办方稽查时所需的流程清单、准备材料、问题解答与法规依据。该页面采用医疗信息系统风格，蓝白配色，适合知识阅读与任务操作。页面模块包括： 1️⃣ 页面顶部页面主标题：“稽查应对支持” 子标题：“展示稽查准备关键流程、工具材料、问题整理与法规支持” 标签导航条：适用角色：CRA / QA / CRC / PI 阶段：执行中 / 锁库前标签：稽查流程 / AE报告 / ICF完整性 / CAPA整改 2️⃣ 知识概述模块简要说明稽查场景与意义列举稽查类型（如：NMPA、伦理审查、申办方稽查）提示稽查准备的高风险区域（如ICF、药物记录、SAE）可配一张流程图或警示图标示意图 3️⃣ 核心任务清单（结构化展示）以卡片或列表展示稽查准备任务：每项任务包含：编号（01～06）操作事项（如“整理ICF签署表”）责任人（如CRC、PI）工具按钮（如：下载模板 / 查看自查表） 4️⃣ 所需工具材料区展示可下载文档列表，内容示例如： CAPA整改模板 ICF稽查核查表稽查访谈话术汇总药物出入库登记本每份材料以卡片或文件模块展示，支持操作：[下载] [预览] [收藏] 5️⃣ 法规引用模块（表格或法规卡片）展示与稽查相关法规条文摘要，结构包括：法规名称（如：GCP、ICH-GCP）条款编号内容摘要操作：[查看原文] 6️⃣ 常见问题解答（FAQ）以问答形式列出稽查相关高频问题，例如： “稽查人员是否可以拍摄现场资料？” “找不到ICF原件怎么办？” “SAE报告延迟后怎么整改？” 每题支持展开答案，并显示引用法规/模板 7️⃣ AI智能问答模块（页面右下角浮动）标题：“问AI · 稽查助手” 提示：输入你遇到的稽查问题，系统将返回答案+依据示例问题： “伦理稽查常见问题有哪些？” “GCP中对文档调阅有哪些规定？” 输出应包含：AI回答摘要 + 原文出处链接 + 推荐材料 8️⃣ 页面底部推荐知识模块标题：“推荐阅读” 横向展示与稽查紧密相关的其他知识点： CAPA整改编写规范 ICF签署核查流程稽查前准备会议纪要模版 AE/SAE应急报告指引 💡 风格要求蓝白为主色，卡片分区清晰信息密度适中，标题与标签对齐整洁所有文档、FAQ 和法规模块统一风格 AI问答模块为右下角可浮动窗口，可收起展开图标可适当用于任务项、法规条、FAQ增强识别 - Initial Deployment

Browse files

Files changed (3) hide show

README.md +6 -4
index.html +408 -19
prompts.txt +1 -0

README.md CHANGED Viewed

@@ -1,10 +1,12 @@
 ---
-title: Detail1
-emoji: 🔥
-colorFrom: blue
 colorTo: green
 sdk: static
 pinned: false
 ---
-Check out the configuration reference at https://huggingface.co/docs/hub/spaces-config-reference

 ---
+title: detail1
+emoji: 🐳
+colorFrom: yellow
 colorTo: green
 sdk: static
 pinned: false
+tags:
+  - deepsite
 ---
+Check out the configuration reference at https://huggingface.co/docs/hub/spaces-config-reference

index.html CHANGED Viewed

@@ -1,19 +1,408 @@
-<!doctype html>
-<html>
-	<head>
-		<meta charset="utf-8" />
-		<meta name="viewport" content="width=device-width" />
-		<title>My static Space</title>
-		<link rel="stylesheet" href="style.css" />
-	</head>
-	<body>
-		<div class="card">
-			<h1>Welcome to your static Space!</h1>
-			<p>You can modify this app directly by editing <i>index.html</i> in the Files and versions tab.</p>
-			<p>
-				Also don't forget to check the
-				<a href="https://huggingface.co/docs/hub/spaces" target="_blank">Spaces documentation</a>.
-			</p>
-		</div>
-	</body>
-</html>

+<!DOCTYPE html>
+<html lang="zh-CN">
+<head>
+    <meta charset="UTF-8">
+    <meta name="viewport" content="width=device-width, initial-scale=1.0">
+    <title>稽查应对支持 | 临床试验知识系统</title>
+    <script src="https://cdn.tailwindcss.com"></script>
+    <link rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/6.4.0/css/all.min.css">
+    <script>
+        tailwind.config = {
+            theme: {
+                extend: {
+                    colors: {
+                        primary: '#1a73e8',
+                        secondary: '#4285f4',
+                        accent: '#34a853',
+                        light: '#f8f9fa',
+                        dark: '#202124'
+                    },
+                    boxShadow: {
+                        'custom': '0 4px 6px rgba(0, 0, 0, 0.05), 0 1px 3px rgba(0, 0, 0, 0.1)',
+                        'custom-lg': '0 10px 15px rgba(0, 0, 0, 0.05), 0 4px 6px rgba(0, 0, 0, 0.1)'
+                    }
+                }
+            }
+        }
+    </script>
+    <style>
+        body {
+            font-family: 'Segoe UI', 'Microsoft YaHei', sans-serif;
+            background-color: #f5f7fa;
+            color: #333;
+        }
+        .header-gradient {
+            background: linear-gradient(135deg, #1a73e8 0%, #4285f4 100%);
+        }
+        .tab-active {
+            border-bottom: 3px solid #34a853;
+            color: #1a73e8;
+            font-weight: 600;
+        }
+        .task-card:hover {
+            transform: translateY(-3px);
+            box-shadow: 0 10px 20px rgba(0, 0, 0, 0.08);
+        }
+        .material-card {
+            transition: all 0.2s ease;
+        }
+        .material-card:hover {
+            box-shadow: 0 8px 16px rgba(0, 0, 0, 0.08);
+            transform: translateY(-2px);
+        }
+        .regulation-card {
+            border-left: 3px solid #4285f4;
+        }
+        .faq-question {
+            transition: all 0.2s ease;
+        }
+        .faq-question:hover {
+            background-color: #edf4fe;
+        }
+        .ai-window {
+            transition: all 0.3s ease;
+            box-shadow: 0 10px 25px rgba(0, 0, 0, 0.15);
+        }
+        .recommendation-card {
+            min-width: 260px;
+        }
+        .flow-chart-container {
+            display: grid;
+            grid-template-columns: 1fr;
+            gap: 20px;
+        }
+        .flow-step {
+            position: relative;
+            padding-left: 40px;
+        }
+        .flow-step:before {
+            content: '';
+            position: absolute;
+            left: 0;
+            top: 0;
+            width: 30px;
+            height: 30px;
+            background-color: #e9f1fd;
+            border-radius: 50%;
+            display: flex;
+            align-items: center;
+            justify-content: center;
+            font-weight: bold;
+            color: #1a73e8;
+        }
+        @media (min-width: 768px) {
+            .flow-chart-container {
+                grid-template-columns: repeat(2, 1fr);
+            }
+        }
+        @media (min-width: 1024px) {
+            .flow-chart-container {
+                grid-template-columns: repeat(4, 1fr);
+            }
+        }
+    </style>
+</head>
+<body class="bg-gray-50">
+    <!-- 头部导航 -->
+    <header class="header-gradient text-white py-4 px-4 md:px-8">
+        <div class="container mx-auto flex justify-between items-center">
+            <div>
+                <h1 class="text-2xl md:text-3xl font-bold">稽查应对支持</h1>
+                <p class="text-blue-100 text-sm md:text-base mt-1">展示稽查准备关键流程、工具材料、问题整理与法规支持</p>
+            </div>
+            <div class="flex items-center space-x-4">
+                <div class="hidden md:block">
+                    <span class="text-sm">临床试验知识系统</span>
+                </div>
+                <div class="bg-white p-1 rounded-full">
+                    <div class="w-8 h-8 bg-gray-200 rounded-full flex items-center justify-center text-primary">
+                        <i class="fas fa-user-md"></i>
+                    </div>
+                </div>
+            </div>
+        </div>
+    </header>
+    <!-- 标签导航条 -->
+    <div class="bg-white py-3 shadow-sm">
+        <div class="container mx-auto px-4">
+            <div class="flex flex-col md:flex-row justify-between md:items-center">
+                <div class="mb-3 md:mb-0">
+                    <span class="font-medium text-gray-600 mr-3">适用角色:</span>
+                    <div class="inline-flex flex-wrap gap-2">
+                        <span class="px-3 py-1 bg-blue-50 text-primary text-sm rounded-full">CRA</span>
+                        <span class="px-3 py-1 bg-blue-50 text-primary text-sm rounded-full">QA</span>
+                        <span class="px-3 py-1 bg-blue-50 text-primary text-sm rounded-full">CRC</span>
+                        <span class="px-3 py-1 bg-blue-50 text-primary text-sm rounded-full">PI</span>
+                    </div>
+                </div>
+                <div>
+                    <span class="font-medium text-gray-600 mr-3">阶段:</span>
+                    <div class="inline-flex flex-wrap gap-2">
+                        <span class="px-3 py-1 bg-green-50 text-accent text-sm rounded-full">执行中</span>
+                        <span class="px-3 py-1 bg-green-50 text-accent text-sm rounded-full">锁库前</span>
+                    </div>
+                </div>
+            </div>
+            <div class="mt-4 flex flex-wrap gap-1 border-t pt-3">
+                <button class="px-4 py-2 bg-primary text-white text-sm rounded-lg font-medium">稽查流程</button>
+                <button class="px-4 py-2 bg-gray-100 text-gray-700 text-sm rounded-lg font-medium">AE报告</button>
+                <button class="px-4 py-2 bg-gray-100 text-gray-700 text-sm rounded-lg font-medium">ICF完整性</button>
+                <button class="px-4 py-2 bg-gray-100 text-gray-700 text-sm rounded-lg font-medium">CAPA整改</button>
+            </div>
+        </div>
+    </div>
+    <div class="container mx-auto px-4 py-8">
+        <!-- 知识概述模块 -->
+        <div class="bg-white rounded-xl shadow-custom mb-8">
+            <div class="p-6 border-b">
+                <h2 class="text-xl font-bold text-primary flex items-center">
+                    <i class="fas fa-info-circle mr-2"></i>稽查概述与准备要点
+                </h2>
+            </div>
+            <div class="p-6">
+                <div class="flow-chart-container">
+                    <div>
+                        <h3 class="font-bold text-gray-700 mb-3">稽查定义与意义</h3>
+                        <p class="text-gray-600 mb-4">
+                            稽查是对临床试验过程的系统性、独立性检查，旨在评估研究操作是否符合法规要求、研究方案以及GCP标准。其目的在于保障受试者权益和数据完整性。
+                        </p>
+                        <div class="bg-yellow-50 border-l-4 border-yellow-400 p-4 rounded mb-4">
+                            <p class="text-yellow-700">
+                                <i class="fas fa-exclamation-triangle mr-2"></i>稽查准备关键点：文件完整性、流程合规性、数据一致性
+                            </p>
+                        </div>
+                    </div>
+                    <div>
+                        <h3 class="font-bold text-gray-700 mb-3">稽查类型</h3>
+                        <div class="space-y-3">
+                            <div class="flex items-start">
+                                <i class="fas fa-flag text-red-500 mt-1 mr-2"></i>
+                                <div>
+                                    <p class="font-medium">NMPA/药监局稽查</p>
+                                    <p class="text-sm text-gray-500">合规性稽查，重点关注方案偏离与数据完整性</p>
+                                </div>
+                            </div>
+                            <div class="flex items-start">
+                                <i class="fas fa-balance-scale text-green-500 mt-1 mr-2"></i>
+                                <div>
+                                    <p class="font-medium">伦理委员会审查</p>
+                                    <p class="text-sm text-gray-500">审查受试者权益保护与文件归档情况</p>
+                                </div>
+                            </div>
+                            <div class="flex items-start">
+                                <i class="fas fa-building text-blue-500 mt-1 mr-2"></i>
+                                <div>
+                                    <p class="font-medium">申办方稽查</p>
+                                    <p class="text-sm text-gray-500">监查过程与试验操作合规性评估</p>
+                                </div>
+                            </div>
+                        </div>
+                    </div>
+                    <div>
+                        <h3 class="font-bold text-gray-700 mb-3">稽查流程</h3>
+                        <div class="flow-step before:content-['1'] before:flex before:items-center before:justify-center">
+                            <p class="font-medium">稽查通知</p>
+                            <p class="text-sm text-gray-500">收到稽查通知并确认范围与日期</p>
+                        </div>
+                        <div class="flow-step mt-4 before:content-['2'] before:flex before:items-center before:justify-center">
+                            <p class="font-medium">材料准备</p>
+                            <p class="text-sm text-gray-500">收集并整理所需文件资料</p>
+                        </div>
+                        <div class="flow-step mt-4 before:content-['3'] before:flex before:items-center before:justify-center">
+                            <p class="font-medium">场地准备</p>
+                            <p class="text-sm text-gray-500">准备稽查场地与人员安排</p>
+                        </div>
+                        <div class="flow-step mt-4 before:content-['4'] before:flex before:items-center before:justify-center">
+                            <p class="font-medium">稽查会议</p>
+                            <p class="text-sm text-gray-500">介绍研究情况并回答问题</p>
+                        </div>
+                        <div class="flow-step mt-4 before:content-['5'] before:flex before:items-center before:justify-center">
+                            <p class="font-medium">后续跟进</p>
+                            <p class="text-sm text-gray-500">处理发现项并提交CAPA报告</p>
+                        </div>
+                    </div>
+                    <div>
+                        <h3 class="font-bold text-gray-700 mb-3">高风险区域</h3>
+                        <div class="bg-red-50 p-4 rounded-lg">
+                            <ul class="space-y-2">
+                                <li class="flex items-start">
+                                    <i class="fas fa-file-contract text-red-500 mt-1 mr-2"></i>
+                                    <span>ICF签署问题（缺失、签署日期异常）</span>
+                                </li>
+                                <li class="flex items-start">
+                                    <i class="fas fa-pills text-red-500 mt-1 mr-2"></i>
+                                    <span>药物记录不一致（库存、发放、回收）</span>
+                                </li>
+                                <li class="flex items-start">
+                                    <i class="fas fa-exclamation-triangle text-red-500 mt-1 mr-2"></i>
+                                    <span>SAE报告延迟或内容不完整</span>
+                                </li>
+                                <li class="flex items-start">
+                                    <i class="fas fa-user-edit text-red-500 mt-1 mr-2"></i>
+                                    <span>数据修改未正确记录（日期、原因、授权）</span>
+                                </li>
+                            </ul>
+                        </div>
+                    </div>
+                </div>
+            </div>
+        </div>
+        <!-- 核心任务清单 -->
+        <div class="bg-white rounded-xl shadow-custom mb-8">
+            <div class="p-6 border-b">
+                <h2 class="text-xl font-bold text-primary flex items-center">
+                    <i class="fas fa-tasks mr-2"></i>稽查前准备任务清单
+                </h2>
+            </div>
+            <div class="p-6 grid grid-cols-1 md:grid-cols-2 lg:grid-cols-3 gap-5">
+                <!-- 任务卡片1 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">01</span>
+                        <span class="px-3 py-1 bg-blue-100 text-primary rounded-full text-sm">PI/CRC</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">整理ICF签署表</h3>
+                    <p class="text-gray-500 text-sm mb-3">核对所有受试者ICF签署日期、版本号、姓名和授权人员</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+                <!-- 任务卡片2 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">02</span>
+                        <span class="px-3 py-1 bg-blue-100 text-primary rounded-full text-sm">CRC</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">准备源数据文件</h3>
+                    <p class="text-gray-500 text-sm mb-3">整理完整的病案资料、实验室报告和其他源文件</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+                <!-- 任务卡片3 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">03</span>
+                        <span class="px-3 py-1 bg-green-100 text-green-700 rounded-full text-sm">CRA</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">药物管理记录核验</h3>
+                    <p class="text-gray-500 text-sm mb-3">核对药物接收、分发、回收和温度记录完整性</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+                <!-- 任务卡片4 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">04</span>
+                        <span class="px-3 py-1 bg-purple-100 text-purple-700 rounded-full text-sm">QA</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">方案偏离/违背审查</h3>
+                    <p class="text-gray-500 text-sm mb-3">整理方案偏离报告并进行分类分级</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+                <!-- 任务卡片5 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">05</span>
+                        <span class="px-3 py-1 bg-blue-100 text-primary rounded-full text-sm">PI</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">伦理批件归档</h3>
+                    <p class="text-gray-500 text-sm mb-3">检查所有伦理委员会的批准文件与修订通知</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+                <!-- 任务卡片6 -->
+                <div class="task-card bg-white border border-gray-200 rounded-lg p-5 transition-all duration-300">
+                    <div class="flex items-center justify-between mb-3">
+                        <span class="bg-primary text-white w-8 h-8 rounded-full flex items-center justify-center font-bold">06</span>
+                        <span class="px-3 py-1 bg-green-100 text-green-700 rounded-full text-sm">CRA</span>
+                    </div>
+                    <h3 class="font-bold text-gray-700 mb-2">稽查前会议准备</h3>
+                    <p class="text-gray-500 text-sm mb-3">准备稽查前会议议程与研究总结PPT</p>
+                    <div class="flex space-x-2">
+                        <button class="px-3 py-1 bg-primary text-white text-xs rounded hover:bg-blue-700">
+                            <i class="fas fa-file-download mr-1"></i>下载模板
+                        </button>
+                        <button class="px-3 py-1 bg-gray-100 text-gray-700 text-xs rounded hover:bg-gray-200">
+                            <i class="fas fa-search mr-1"></i>查看自查表
+                        </button>
+                    </div>
+                </div>
+            </div>
+        </div>
+        <div class="grid grid-cols-1 lg:grid-cols-2 gap-8">
+            <!-- 所需工具材料区 -->
+            <div class="bg-white rounded-xl shadow-custom">
+                <div class="p-6 border-b">
+                    <h2 class="text-xl font-bold text-primary flex items-center">
+                        <i class="fas fa-toolbox mr-2"></i>稽查支持工具与材料
+                    </h2>
+                </div>
+                <div class="p-6">
+                    <div class="grid grid-cols-1 md:grid-cols-2 gap-4">
+                        <!-- 材料1 -->
+                        <div class="material-card flex items-center border border-gray-200 p-4 rounded-lg">
+                            <div class="bg-blue-50 p-3 rounded mr-4">
+                                <i class="fas fa-file-alt text-primary text-xl"></i>
+                            </div>
+                            <div class="flex-grow">
+                                <h3 class="font-bold">CAPA整改模板</h3>
+                                <p class="text-sm text
+<p style="border-radius: 8px; text-align: center; font-size: 12px; color: #fff; margin-top: 16px;position: fixed; left: 8px; bottom: 8px; z-index: 10; background: rgba(0, 0, 0, 0.8); padding: 4px 8px;">Made with <img src="https://enzostvs-deepsite.hf.space/logo.svg" alt="DeepSite Logo" style="width: 16px; height: 16px; vertical-align: middle;display:inline-block;margin-right:3px;filter:brightness(0) invert(1);"><a href="https://enzostvs-deepsite.hf.space" style="color: #fff;text-decoration: underline;" target="_blank" >DeepSite</a> - 🧬 <a href="https://enzostvs-deepsite.hf.space?remix=maomaobj/detail1" style="color: #fff;text-decoration: underline;" target="_blank" >Remix</a></p></body>
+</html>

prompts.txt ADDED Viewed

	@@ -0,0 +1 @@

+ 请为我设计一个专业、结构化、模块清晰的知识页面，主题为 “稽查应对支持”，用于展示临床试验中应对药监局或申办方稽查时所需的流程清单、准备材料、问题解答与法规依据。该页面采用医疗信息系统风格，蓝白配色，适合知识阅读与任务操作。页面模块包括： 1️⃣ 页面顶部页面主标题：“稽查应对支持” 子标题：“展示稽查准备关键流程、工具材料、问题整理与法规支持” 标签导航条：适用角色：CRA / QA / CRC / PI 阶段：执行中 / 锁库前标签：稽查流程 / AE报告 / ICF完整性 / CAPA整改 2️⃣ 知识概述模块简要说明稽查场景与意义列举稽查类型（如：NMPA、伦理审查、申办方稽查）提示稽查准备的高风险区域（如ICF、药物记录、SAE）可配一张流程图或警示图标示意图 3️⃣ 核心任务清单（结构化展示）以卡片或列表展示稽查准备任务：每项任务包含：编号（01～06）操作事项（如“整理ICF签署表”）责任人（如CRC、PI）工具按钮（如：下载模板 / 查看自查表） 4️⃣ 所需工具材料区展示可下载文档列表，内容示例如： CAPA整改模板 ICF稽查核查表稽查访谈话术汇总药物出入库登记本每份材料以卡片或文件模块展示，支持操作：[下载] [预览] [收藏] 5️⃣ 法规引用模块（表格或法规卡片）展示与稽查相关法规条文摘要，结构包括：法规名称（如：GCP、ICH-GCP）条款编号内容摘要操作：[查看原文] 6️⃣ 常见问题解答（FAQ）以问答形式列出稽查相关高频问题，例如： “稽查人员是否可以拍摄现场资料？” “找不到ICF原件怎么办？” “SAE报告延迟后怎么整改？” 每题支持展开答案，并显示引用法规/模板 7️⃣ AI智能问答模块（页面右下角浮动）标题：“问AI · 稽查助手” 提示：输入你遇到的稽查问题，系统将返回答案+依据示例问题： “伦理稽查常见问题有哪些？” “GCP中对文档调阅有哪些规定？” 输出应包含：AI回答摘要 + 原文出处链接 + 推荐材料 8️⃣ 页面底部推荐知识模块标题：“推荐阅读” 横向展示与稽查紧密相关的其他知识点： CAPA整改编写规范 ICF签署核查流程稽查前准备会议纪要模版 AE/SAE应急报告指引 💡 风格要求蓝白为主色，卡片分区清晰信息密度适中，标题与标签对齐整洁所有文档、FAQ 和法规模块统一风格 AI问答模块为右下角可浮动窗口，可收起展开图标可适当用于任务项、法规条、FAQ增强识别