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国家药监局 国家卫生健康委关于发布 《医疗器械临床试验质量管理规范》的公告（2022年第28号）
国家药监局关于发布体外诊断试剂临床试验技术指导原则的通告（2021年第72号）
医疗器械临床试验检查要点及判定原则
体外诊断试剂注册与备案管理办法
体外诊断试剂注册管理办法（现行版本）
医疗器械注册与备案管理办法
医疗器械注册管理办法（现行版本）
医疗器械监督管理条例
Introduction to RECIST 1.1
Expanded Access Programs
Patient registries: an overview
Adaptive Clinical Trials (ACT) for Medical Device
Adaptive Clinical Trials (ACT)for Drug and Biometrics
药物临床试验伦理审查工作指导原则
临床试验的电子数据采集技术指导原则
药物临床试验数据管理与统计分析的计划和报告指导原则
临床试验数据管理工作技术指南
药物临床试验的生物统计学指导原则
US Legislation FDA Regulations on Clinical Trial
EudraLex - Volume 10 Clinical trials guidelines
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