从检查员视角看新修订《药物临床试验质量管理规范》对申办者的要求  

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

作　　者：张琼光 刘珊 余甜 韩聪凡 徐立靖 王钰 高荣 ZHANG Qiong-guang;LIU Shan;YU Tian;HAN Cong-fan;XU Li-jing;WANG Yu;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3379-3384,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：申办者作为临床试验的发起组织者、经费提供者和数据质量的最终责任人,是临床试验的重要主体。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申办者相关问题,从检查员视角分析和探讨新修订的GCP对申办者的要求,为申办者在药物临床试验实施过程中更好地履责提供借鉴。The sponsor,who takes responsibilities for the initiation,management,financing and data quality of a clinical trial,plays an important role in drug clinical trials. According to the newly revised Good Clinical Practice( GCP) and combined with the problems of the sponsor found in the clinical trial inspections,this paper analyzed and discussed the requirements of the newly revised GCP for sponsor from the perspective of clinical trial inspectors. It provides reference for sponsor 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 申办者 

分 类 号：R95[医药卫生—药学]