疫苗Ⅰ期临床试验准备阶段的质量体系建设  

Quality system construction in the preparation stage of phaseⅠvaccine clinical trial

作　　者：魏琼[1] 曹钰然[2] 张菁[1] 曹国英[1,2] 吴翠云[3] 伍蓉[3] 杨海静[1] 武晓捷[1] 郁继诚[1] WEI Qiong;CAO Yu-ran;ZHANG Jing;CAO Guo-ying;WU Cui-yun;WU Rong;YANG Hai-jing;WU Xiao-jie;YU Ji-cheng(Phase I Clinical Trial Center,Huashan Hospital,Fudan University,Shanghai 200040,China;Office of Drug Clinical Trials Institution,Huashan Hospital,Fudan University,Shanghai 200040,China;Institutional Review Board,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院Ⅰ期临床研究室,上海200040 [2]复旦大学附属华山医院药物临床试验机构办公室,上海200040 [3]复旦大学附属华山医院伦理审查委员会,上海200040

出　　处：《中国临床药理学杂志》2020年第19期3154-3156,共3页The Chinese Journal of Clinical Pharmacology

基　　金：国家科技部“重大新药创制”科技重大专项资助项目(2017ZX09304005)。

摘　　要：疫苗临床试验的组织管理较一般药物临床试验更复杂、对质量管理的要求更高。本文从疫苗临床试验相关法律法规和指南梳理、机构和人员资质、试验场地要求、疫苗临床试验相关标准操作规程制定、伦理审查委员会要求这几个关键点入手,分析Ⅰ期临床试验准备阶段的质量体系建设的关注点,旨在为正在准备开展疫苗临床试验的同仁提供参考。The organization and management of vaccine clinical trials are more complex than those of general drug clinical trials and require higher quality management.This article starts with the following key points:the relevant laws and regulations and guidelines,the qualifications of the institution and personnel,the requirements of site,the relevant standard operating procedures and the ethics review committee requirements to discuss the focus of the quality system construction in the preparation stage of vaccine clinical trials,hoping to provide reference for colleagues who are preparing to carry out vaccine clinical trials.

关 键 词：新型冠状病毒肺炎 疫苗 临床试验 质量 

分 类 号：R97[医药卫生—药品]