临床试验远程数据监查系统的构建与实施  

Construction and Application of the Remote Data Monitoring System for Clinical Trials

作　　者：刘灵晔 李娟[1] 戴建[1] 王健[2] 束睿 鲁萌[1] 朱静静[1] LIU Lingye;LI Juan;DAI Jian;WANG Jian;SHU Rui;LU Meng;ZHU Jingjing(National Drug Clinical Trial Center,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;Technology Department,the Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院国家药物临床试验机构,南京210008 [2]南京大学医学院附属鼓楼医院科技处,南京210008

出　　处：《药学与临床研究》2022年第2期174-178,共5页Pharmaceutical and Clinical Research

基　　金：江苏省药学会—天晴医院药学基金科研项目(Q202004)。

摘　　要：目的:规范临床试验数据监查过程,实现远程监查,探讨本院临床试验远程数据监查系统的构建和实际应用中的问题,为同行提供参考。方法:分析总结原临床试验监查模式和流程,在符合2020版《药物临床试验质量管理规范》前提下,设计适合远程监查模式的信息化管理系统,应用于各监查应用场景中。结果:系统通过不同角色权限设定,规范监查人员账号管理和项目管理,实现受试者信息集成、查阅、溯源和相关原始资料的远程核对,通过系统内外部防护功能,保障了医疗数据、项目数据和受试者隐私安全。结论:临床试验远程数据监查系统的建立,在保证数据安全前提下,实现了远程监查,提高了监查效率,进一步提升机构信息化管理水平。Objective:To standardize the clinical trial monitoring process,realize remote monitoring,discuss the construction and practical application of the remote data monitoring system for clinical trials,and provide reference for peers.Methods:The original clinical trial monitoring mode and process of the hospital were analyzed and summarized.On the premise of conforming to the new Good Clinical Practice,an information management system suitable for the remote monitoring mode was designed and applied in various monitoring scenarios.Results:The system regulated the account management of monitors and project management through setting different roles and permissions,and realized integration,inspection and tracing of subject information and remote source data verification.The medical and project data and subject privacy were ensured with the internal and external protection of the system.Conclusions:The establishment of the remote data monitoring system for clinical trials,on the premise of ensuring data security,realized remote monitoring,improved the monitoring efficiency,and further improved the level of institutional information management.

关 键 词：临床试验 远程监查 信息化管理 

分 类 号：R95[医药卫生—药学]