临床试验纸质文件受控管理规范性探讨  

Discussion on the standardization of controlled management of clinical trial paper documents

作　　者：陈希 陈红[1] 蔡名敏 杨玥 张如梦 翟紫红[1] 王桂梅[1] 王慧萍[1] CHEN Xi;CHEN Hong;CAI Mingmin;YANG Yue;ZHANG Rumeng;ZHAI Zihong;WANG Guimei;WANG Huiping(Drug Clinical Trial Institution of Zhongda Hospital,Affiliated to Southeast University,Nanjing,Jiangsu 210009,China)

机构地区：[1]东南大学附属中大医院临床试验机构办公室,江苏南京210009

出　　处：《中国临床研究》2023年第11期1718-1721,共4页Chinese Journal of Clinical Research

基　　金：江苏省药品监督管理局科研计划课题(202106)。

摘　　要：数据质量事关临床试验结果评价,规范化的数据记录则是保证临床试验数据可溯源的重要依据。我国临床试验数据管理目前处于纸质与电子文件并存的阶段。本文通过分析我国临床试验数据管理现状、临床试验质量管理相关法律法规及指导原则中文件管理的要求,结合实际管理经验明确临床试验相关纸质文件受控管理的流程,旨在从文件管理的角度进一步规范临床试验数据管理,为广大临床试验机构提供参考。The quality of data is related to the evaluation of clinical trial results,and standardized data recording is an important basis for ensuring the traceability of clinical trial data.Clinical trial data management in China is currently in a stage where both paper and electronic documents are used.This article analyzes the current status of clinical trial data management in China,as well as the requirements for document management in relevant laws,regulations,and guidelines for clinical trial quality management.Based on practical management experience,it outlines the process of controlled management for paper documents related to clinical trials.The aim is to further standardize clinical trial data management from the perspective of document management and provide reference for clinical trial institutions.

关 键 词：临床试验 数据记录 纸质文件 受控管理 

分 类 号：R95[医药卫生—药学]