2020版《药物临床试验质量管理规范》实施后药物临床试验数据现场核查的要点与浅析  

Key points and analysis for on-site verification of drug clinical trial data after the implementation of the 2020 ‘Good Clinical Practice’

作　　者：曹丽亚 谢林利 谢江川 潘辛梅 马攀 陈勇川 CAO Li-ya;XIE Lin-li;XIE Jiang-chuan;PAN Xin-mei;MA Pan;CHEN Yong-chuan(Department of Pharmacy,First Affiliated Hospital of Army Medical University,PLA,Chongqing 400038,China)

机构地区：[1]中国人民解放军陆军军医大学第一附属医院药剂科,重庆400038

出　　处：《中国新药杂志》2023年第3期264-269,共6页Chinese Journal of New Drugs

摘　　要：目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临床试验数据现场核查常见问题的关注点及要求,以期为临床试验的实施和管理提供参考。方法:收集本院自2015年7月22日以来接受CFDI数据现场核查的不合格情况,共计21个项目接受临床试验核查,不合格项135条。针对既往不合格项中的常见问题,分析2020版GCP和现场核查的关注点及要求。结果:既往不合格项主要集中在过程记录及检查检验数据溯源、方案执行、安全性事件记录、试验用药品的管理与记录、生物样品流通管理、相关数据链的完整性等方面。2020版GCP与现场核查要点对于临床试验数据现场核查常见问题与既往要求有较大差异。结论:在新形势下,需改变既往观念和规则,根据2020版GCP和药物临床试验数据现场核查的关注点及要求开展药物临床试验。Objective: To sort out the previous on-site inspection of clinical trial data by the Center for Food and Drug Inspection(CFDI) of National Medical Products Administration(NMPA), to analyze and discuss the concerns and requirements of common problems in on-site inspection of drug clinical trial data after the implementation of the 2020 Good Clinic Practice(GCP), and to provide reference for the implementation and management of clinical trials. Methods: We collected unqualified situation of the on-site verification of hospital’s acceptance of CFDI data since July 22, 2015. A total of 21 items of clinical trials were included, among which 135 items were unqualified. For the common problems in the past non-conformities, the concerns and requirements of the 2020 version of GCP and on-site inspection were analyzed. Results: The previous unqualified items mainly focused on process records, as well as inspection and inspection of data traceability, program execution, safety event records, management and records of investigational drugs, biological sample circulation management, and the integrity of related data chains. The 2020 GCP and on-site verification points were quite different from the previous requirements regarding common problems in on-site verification of clinical trial data. Conclusion: Under this new situation, it is necessary to change the previous concepts and rules, and carry out drug clinical trials according to the concerns and requirements of the 2020 version of GCP and the data on-site verification of drug clinical trials.

关 键 词：临床试验 药物临床试验质量管理规范 药品注册核查 质量管理 

分 类 号：R95[医药卫生—药学]