临床试验研究者监管的现状和分析  

Current status and analysis of clinical investigators supervision in clinical trials

作　　者：孙搏 张景辰 李刚 SUN Bo;ZHANG Jing-chen;LI Gang(Shanghai Center for Drug Evaluation and Inspection,SHANGHAI 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《中国新药与临床杂志》2023年第9期571-576,共6页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：研究者是临床试验的关键主体,是临床试验的实施者及试验质量、受试者权益和安全的直接责任人。本文梳理了近年来美国、欧盟对药物临床试验研究者的监管情况,结合我国药品注册现场核查和临床试验机构日常监管工作中发现的问题,分析国内临床试验研究者监管现状,从监管模式、缺陷的分类管理和监管措施、监管机构合作和后续工作方向等方面探讨对我国药物临床试验监管工作的启示。Clinical investigators are the key subjects of clinical trials,the implementers of clinical trials,and the direct responsible persons for the quality of trials and the rights and safety of subjects.This article summarizes the regulatory situation of drug clinical trial researchers in the United States and the European Union in recent years,analyzes the current situation of domestic researcher supervision combined with the findings in the on-site verification for drug registration and the routine supervision of clinical trial institutions in China,and discusses the inspiration for the supervision of drug clinical trials in China from the perspectives of regulatory models,classification management and regulatory measures for defects,regulatory agency cooperation,and future work direction.

关 键 词：药物临床试验质量管理规范 临床试验 临床研究者 检查 

分 类 号：R954[医药卫生—药学]