医疗机构临床试验质量控制标准实践研究  

The Practice Rresearch on Clinical Trial Quality Control Standards

作　　者：刘泽干 蔡蒋帆 马俊龙 李海平[1] 唐莉[1] 张澈[1] LIU Ze-gan;CAI Jiang-fan;MA Jun-long;LI Hai-ping;TANG Li;ZHANG Che(Affiliated Taihe Hospital of Hubei University of Medicine,Hubei Shiyan 422000,China)

机构地区：[1]湖北医药学院附属十堰市太和医院,湖北十堰442000

出　　处：《中国药物评价》2021年第1期79-84,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:建立机构内部的临床试验质量控制标准,规范临床试验质量控制工作。方法:根据质量控制实施阶段及侧重点,对质控进行分类;制定以项目启动质控细则及知情同意书、筛选入选表、研究者文件夹等单元模块质控细则,并依照已制定的质量控制标准实施质量控制。结果:制定以质控分类、质控标准细则、质控流程、质控问题判定为内容的临床试验质量控制标准;依照标准实施了26次质控检查,共查找出问题327条,未发现重大问题,其中主要问题8条,次要问题87条,一般问题232条。结论:制定的临床试验质量控制标准具有较强的实施操作性,能有效规范临床试验质控行为,具有一定实践和参考价值。Objective:To establish internal clinical trial quality control(QC)standards and standardize clinical trial QC work.Methods:The QC standards were classified according to the implementation period and the key points of QC.The QC standards,including the project start-up rules,informed consent,screening list,researcher folder,etc.as the unit module QC rules,were formulated.And the implement of QC was in accordance with the established QC standards.Results:The clinical trial QC standards consisting of classification,standard rules,procedures,problem determination of QC were established.26 quality control inspections were carried out in accordance with the standards,and a total of 327 problems were found,of which 8 were main questions,87 were minor questions,and 232 were general questions,and no major problems were found.Conclusion:The established quality control standard of clinical trials has strong operability,can effectively standardize the quality control behavior of clinical trials,and has certain practical and reference value.

关 键 词：临床试验 质量控制 质量管理 标准 药物临床试验质量管理规范 

分 类 号：R95[医药卫生—药学]