从检查员视角看新修订《药物临床试验质量管理规范》对伦理委员会的要求  

Perspectives on the requirements of the newly revised Good Clinical Practice for ethics committee from clinical trial inspectors

作　　者：张琼光 宋福鱼 宁靖 袁铭 李秀丽 龚梦 高荣 ZHANG Qiong-guang;SONG Fu-yu;NING Jing;YUAN Ming;LI Xiu-li;GONG Meng;GAO Rong(Center for Food and Drug Inspection of National Medical Products Administration,National Center for vaccine Inspection,Beijing 100044,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,国家疫苗检查中心,北京100044

出　　处：《中国临床药理学杂志》2021年第24期3385-3388,3396,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：伦理审查是保障受试者权益和安全的重要措施之一。本文根据新修订的《药物临床试验质量管理规范》(GCP),结合药物临床试验注册核查发现的伦理委员会相关问题,从检查员视角分析和探讨新修订的GCP对伦理委员会的要求,为伦理委员会在药物临床试验实施过程中更好地履责提供借鉴。Ethical review is one of the important measures to protect subjects’ rights and security. According to the newly revised Good Clinical Practice( GCP) and combined with the problems of the ethics committee found in the clinical trial inspections,this paper analyzed and discussed the requirements of the newly revised GCP for ethics committee from the perspective of clinical trial inspectors. It provides reference for ethics committee to better fulfill its responsibilities in the implementation of drug clinical trials.

关 键 词：药物临床试验质量管理规范 药物临床试验 伦理委员会 要求 

分 类 号：R97[医药卫生—药品]