研究者发起的临床研究中心化监查方案的构建与实施  

Construction and implementation of a centralized monitoring scheme for investigator initiated trials

作　　者：吕文文 段磊 钱颖 杨旭旭 姜嘉媛 焦佳丽 刘伟钰 胡婷婷 董仲勋 钱碧云 Lyu Wenwen;Duan Lei;Qian Ying;Yang Xuxu;Jiang Jiayuan;Jiao Jiali;Liu Weiyu;Hu Tingting;Dong Zhongxun;Qian Biyun(Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;National Institute of Parasitic Diseases,Chinese Center for Disease Control and Prevention(Chinese Center for Tropical Diseases Research),Shanghai 200025,China;Department of Clinical Research Promotion and Development,Shanghai Hospital Development Center,Shanghai 200050,China;School of Public Health,Shanghai Jiao Tong University,Shanghai 200025,China;Institute of Translation Medicine,Shanghai Jiao Tong University,Shanghai 200240,China)

机构地区：[1]上海交通大学医学院临床研究中心,上海200025 [2]中国疾病预防控制中心寄生虫病预防控制所(国家热带病研究中心),上海200025 [3]上海申康医院发展中心临床研究发展部,上海200050 [4]上海交通大学公共卫生学院,上海200025 [5]上海交通大学转化医学研究院,上海200240

出　　处：《中华医院管理杂志》2024年第12期964-968,共5页Chinese Journal of Hospital Administration

基　　金：上海市科技创新行动计划软科学研究项目(23692115100);上海市专业技术服务平台项目(23DZ229060);上海交通大学“交大之星计划医工交叉研究项目”(YG2022QN004)。

摘　　要：中心化监查是一种基于风险的远程监查模式,能有效提高监查效率和质量。2023年7—9月,本研究构建了研究者发起的临床研究(investigator-initiated trials,IIT)中心化监查方案。该方案通过借助电子数据采集系统和临床研究文档管理系统,采用编程技术对项目关键流程和数据进行一致性比对,监查数据填充、分布和逻辑关系等情况以及知情同意书、方案违背记录和不良事件报告等文件,能够及时发现临床研究存在的问题,制定针对性的应对措施。2023年10—12月,6名专家采用该方案对153个IIT项目进行中心化监查,发现在方案执行(86个项目)、伦理批件(68个项目)以及知情同意书(67个项目)等方面存在共性问题,并制定了应对措施,该过程共耗时20 d,每个项目平均耗时6.27 h。与传统现场监查相比,本研究制定的中心化监查方案在时效方面表现出一定优势,可指导现场监查工作高效开展,为三级公立医院提升临床试验质量提供参考。Centralized monitoring is a risk-based remote monitoring mode that can effectively improve monitoring efficiency and quality.From July to September 2023,this study developed a centralized monitoring scheme for investigator initiated trials(IIT).This scheme utilized electronic data collection system and clinical research document management system,using programming techniques to compare the consistency of key project processes and data,monitor data filling,distribution trends,logical relationships,as well as documents such as informed consent forms,protocol violation records,and adverse event reports.It could timely identify problems in clinical trials and develop targeted response measures.From October to December 2023,6 experts conducted centralized monitoring for 153 IIT projects using this scheme and found common issues in program execution(86 projects),ethical approvals(68 projects),and informed consent forms(67 projects),and so on.At the scome time,corresponding measures were developed.The process took a total of 20 days,with an average time of 6.27 hours per project.Compared with traditional on-site monitoring,the centralized monitoring scheme developed in this study had shown certain advantages in terms of timeliness,which could help guide the efficient implementation of on-site monitoring work and provide references for tertiary public hospitals to improve the quality of clinical trials.

关 键 词：临床研究 中心化监查 关键流程 关键数据 风险应对措施 

分 类 号：R197.323[医药卫生—卫生事业管理]