从检查员视角看新修订《药物临床试验质量管理规范》对研究者的要求  

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

作　　者：张琼光 王洪 申鸽 王莹 王童超 马君 高荣 ZHANG Qiong-guang;WANG Hong;SHEN Ge;WANG Ying;WANG Tong-chao;MA Jun;GAO Rong(Center for Food and Drag 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23期3300-3304,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：研究者作为临床试验的实施者、试验质量及受试者权益和安全的直接责任人,是临床试验的关键主体。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研究者相关问题,从检查员视角分析和探讨新修订的GCP对研究者的要求,为研究者在药物临床试验实施过程中更好地履责提供借鉴。The investigator,who is directly responsible for the trials’quality as well as subjects’safety and rights as the implementer,plays a critical role in drug clinical trials.According to the newly revised Good Clinical Practice(GCP)and combined with the problems of the investigator found in the clinical trial inspections,this paper analyzed and discussed the requirements of the newly revised GCP for investigator from the perspective of clinical trial inspectors.It provides reference for investigator 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 研究者 

分 类 号：R95[医药卫生—药学]