2022 年第 6 期 第 17 卷

临床试验受试者免费检验检查流程监管及数据溯源信息系统的设计与应用

Design and application of process supervision of free-examination and data traceability information system of subjects in clinical trials

作者：秦艳玲1陈健2程晨1刘珏1

英文作者：Qin Yanling1 Chen Jian2 Cheng Chen1 Liu Jue1

单位：1华中科技大学同济医学院附属武汉中心医院武汉市中心医院药物临床试验机构办公室，武汉430014；2华中科技大学同济医学院附属武汉中心医院武汉市中心医院信息科，武汉430014

英文单位：1Drug Clinical Trials Agency Office Wuhan Central Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology the Central Hospital of Wuhan Wuhan 430014 China; 2Department of Information Wuhan Central Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology the Central Hospital of Wuhan Wuhan 430014 China

关键词：药物临床试验质量管理规范；临床试验；免费检验检查；数据溯源；设计与应用

英文关键词：Standardforqualitymanagementofdrugclinicaltrials;Clinicaltrial;Free-examination;Datatraceability;Designandapplication

• 摘要：

• 临床试验中如何做好受试者免费检查的流程监管及溯源是药物临床试验机构管理面临的难题。本研究在医院信息管理系统基础上设计了一套临床试验免费检查信息化系统，同步嵌入受试者全息视图系统。该信息化系统保障了在医院同一系统中临床试验受试者检验检查得以免费，同时符合各医疗环节的诊疗规范，患者全息视图嵌入，方便医师进行既往史追踪，更便于临床试验各阶段原始病历数据溯源。该信息化系统在100多个项目，1 000名受试者实施，明显减少了因开具纸质免费申请单导致的手工错误发生率，避免临床试验检验检查费用与医疗保险费用混淆不清，减轻机构办公室的管理压力，更重要的是解决了临床试验检验检查数据溯源难题。该系统基于本院医疗信息化管理系统，便于临床使用，性价比高，有效提升了临床试验中免费检验检查效率，优化了受试者检验检查流程，提升了受试者检验检查体验感受，有利于临床试验经费的核算，实现了临床试验免费检验检查及各阶段源数据溯源的全流程动态监管，为医院的药物/医疗器械临床试验工作提供了借鉴和参考。

• It is a difficult problem for many clinical trial institutions to achieve high-quality supervision for free-examination and data traceability in clinical trial subjects. On the basis of the present medical management system of our hospital, a new information system for the free-examination in clinical trials is designed, and a new holographic view system is embedded synchronously. The newly-designed information system ensures the implementation of free-examination for the subjects in trials as well as standardized diagnosis and treatment process just like ordinary patients. With the introduction of the holographic view system, investigators can easily access both the past history records and all the medical documents generated during trials in our hospital. This information system has been applied in more than 100 projects and 1 000 subjects, which significantly reduces the occurrence of errors used to be made in paper version, avoids the confusion between free-examination and medical insurance, and lighten the workload of institutional officers. More importantly above all, it can solve the problems of data traceability in clinical trials. The system is designed based on the local medical system, which has the characteristics of convenience and high cost performance. The new system increases the efficiency of free-examination in trials, provides the process optimization, improves the participants′ experience, simplifies the financial accounting process, and realizes the whole process dynamic monitoring of date traceability of trials. It has been proven that this system provides references for both drug and medical device clinical trials.