疫情下远程临床试验监查稽查系统的建设和应用  

Construction and Application of Remote Clinical Trial Monitoring and Auditing System Under the Pandemic

作　　者：刘祖玫 卢慧勤[1] 陈燕[1] 连万民[2] 李观明[1] LIU Zumei;LU Huiqin;CHEN Yan;LIAN Wanmin;LI Guanming(Department of Clinicial Research,Guangdong Second Provincial General Hospital,Guangzhou,Guangdong 510317,China;Department of Information,Guangdong Second Provincial General Hospital,Guangzhou,Guangdong 510317,China)

机构地区：[1]广东省第二人民医院临床研究部,广东广州510317 [2]广东省第二人民医院信息科,广东广州510317

出　　处：《今日药学》2023年第3期236-240,共5页Pharmacy Today

基　　金：广东省医学科学技术研究基金项目(C2020018,C2020020)。

摘　　要：通过数字化系统进行远程监查稽查,可减轻申办者及相关管理方对临床试验进行评估和质控的时间及经济成本,控制临床研究的数据质量和完成进度,在疫情期间减少人员流动及感染的风险。本文通过梳理现行法规标准及实践需要,总结了远程监查稽查系统建设中应考虑的要点,并依托广东省某三甲医院的信息化系统建设,建立远程监查稽查系统并在临床监察中进行了应用。数字化的远程监查稽查系统便于汇总多系统的源数据进行核对与溯源,在受试者信息自动脱敏、监查稽查留痕质控、结论确认反馈、跨项目跨中心数据汇总分析等方面具有独到的优势,并有助于从监查稽查环节的信息化推动临床试验全流程数字化。Remote monitoring and auditing through digital system can reduce the time and economic costs for sponsors and managing administrations to evaluate clinical trials,manage the data quality and clinical trial progress,and reduce the risk of infection during the pandemic.By analyzing current regulation requirements and practical needs,we summarized the key points which were taken into consideration in designing a remote monitoring and auditing system for clinical trials.By integrating the information system of a certain grade A tertiary hospital of Guangdong,we established and implemented a remote monitoring and auditing system.A digitalized system can compile data from multiple systems for verification and tracing,and have unique advantages in automatic data desensitization,monitor and audition tracking,conclusion confirmation and feedback,and cross-project and cross-center data analysis.Its implementation can help to improve the digitalization of the entire clinical trial process from the informatization of monitoring and auditing link.

关 键 词：临床试验 远程监查稽查 系统信息化 质量控制 

分 类 号：R95[医药卫生—药学]