临床试验机构档案管理专家共识  

Expert consensus for archives management of clinical trial institutions

作　　者：肖爽[1] 陈华芳[2] 程晓华[3] 唐玉[4] 朱雪琦[1] 倪瑾 曹彩 王少华 程金莲[1] XIAO Shuang;CHEN Huafang;CHENG Xiaohua;TANG Yu;ZHU Xueqi;NI Jin;CAO Cai;WANG Shaohua;CHENG Jinlian(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;The First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;The First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Cancer Hospital Chinese Academy of Medical Sciences,Beijing 100021,China;The First Affiliated Hospital of Naval Medical University,Shanghai 200433,China;Zhongguancun Jiutai Good Clinical Practice Union,Beijing 100027,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]温州医科大学附属第一医院,浙江温州325000 [3]南昌大学第一附属医院,江西南昌330006 [4]中国医学科学院肿瘤医院,北京100021 [5]海军军医大学第一附属医院,上海200433 [6]北京中关村玖泰药物临床试验技术创新联盟,北京100027

出　　处：《药物评价研究》2023年第9期1854-1862,共9页Drug Evaluation Research

基　　金：北京中医医院院级课题暨两院合作项目(LY201801,LY201807);国家“十三五”重大新药创制专项课题(2019ZX09734001)。

摘　　要：临床试验档案是临床试验管理的重要组成部分和临床试验的重要环节,临床试验档案管理是否规范直接关系到对临床试验的科学性、真实性、准确性及可靠性评价,也关系到受试者权益保护。主要论述《临床试验机构档案管理专家共识》的起草背景、制定依据和适用范围,以及临床试验档案管理要求、管理的主要环节,非纸质介质档案管理的特殊要求、专业科室临床试验资料管理要求,以期加强临床试验机构档案规范化管理,有效保护和利用临床试验档案,确保临床试验机构档案完整、准确、可用、安全。Clinical trial archives are an important part of clinical trial management and an important link of clinical trials.Whether the management of clinical trial archives is standardized is directly related to the scientific,authentic,accurate and reliable evaluation of clinical trials,as well as the protection of the rights and interests of subjects.This paper mainly discusses the drafting background,formulation basis and application scope of the standard"Expert consensus for archives management of clinical trial institutions",as well as the requirements and main links of the management of clinical trial archives,the special requirements for the management of non-paper media archives,and the requirements for the management of clinical trial materials of professional departments,with a view to strengthening the standardized management of clinical trial institutions'archives,effectively protecting and utilizing clinical trial archives,and ensuring the integrity accurate,usable and safe.

关 键 词：临床试验 临床试验档案 临床试验资料 档案管理 标准 

分 类 号：R951[医药卫生—药学]