摘要
新型冠状病毒肺炎在全球的大流行使得临床试验的监查受到了前所未有的挑战,伴随着信息技术的快速发展,以及我国临床试验的信息化的建设,推动了临床试验远程监查的发展。在此背景下,临床试验的从业人员须考虑如果保证远程监查的实施条件、安全性保障以及实施的过程。本文由中国临床研究能力提升与受试者保护高峰论坛(CCHRPP)组委会邀请多位临床试验行业的资深专家,组成工作委员会,讨论并达成基于源文件查阅的远程监查的共识,形成工作指引,供临床试验从业人员参考。
The global pandemic of coronavirus disease 2019(COVID-19)has brought unprecedented challenges to the monitoring of clinical trials.With the rapid development of information technology and the information construction of clinical trials,the development of remote monitoring of clinical trials has been promoted.In this context,clinical trial practitioners must consider the implementation conditions of remote monitoring,data security and implementation process.In this paper,the working commitee of China Forums of Clinical Research Capacity Building and Human Research Participants Protection(CCHRPP)invited a number of senior experts in the clinical trial industry to form a working committee to discuss and reach a consensus on remote monitoring based on source document access,and form a working guide for clinical trial practitioners.
作者
许重远
元唯安
沈一峰
曹玉
王莹
余勤
刘琳娜
李慧
赵俭
张宏伟
XU Zhong-yuan;YUAN Wei-an;SHEN Yi-feng;CAO Yu;WANG Ying;YU Qin;LIU Lin-na;LI Hui;ZHAO Jian;ZHANG Hong-wei(Clinical Pharmacy Center,Nanfang Hospital,Southern Medical University,Guangzhou 510515,Guangdong Province,China;GCP Center,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Clinical Research Center,Shanghai Mental Health Center,Shanghai 200030;Clinical Trial Center,The Afiliated Hospital of Qingdao University,Qingdao 266003,Shandong Province,China;Clinical Trial Office,Affiliated Hangzhou First People's Hospital,Zhejiang University School of Medicine,Hangzhou 301003,Zhejiang Province,China;Clinical Trial Center,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Clinical Research Center Office,Tangdu Hospital,Air Force Medical University,Xi'an 710038,Shaanxi Province,China;Clinical Research Center Office,Shengjing Hospital of China Medical University,Shenyang 110004,Liaoning Province,China;Clinical Research Monitoring Department,Jiangsu Hengrui Medicine Co.,Lud,Lianyungang 222000,Jiangsu Province,China;Digital Clinical Trial BU,Zhejiang Taimei Medical Technology Co.,Ltd,Shanghai 200233,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2023年第9期1364-1368,共5页
The Chinese Journal of Clinical Pharmacology
关键词
药物临床试验
远程监查
源文件
管理共识
drug clinical trials
remote monitoring
source file
management consensus
