基于风险控制对临床试验管理信息化系统的构建  

Construction of Clinical Trial Management Information System Based on Risk Control

作　　者：周心娜 续畅 韩兵 王鹏 田宗梅 王兴河 ZHOU Xinna;XU Chang;HAN Bing;WANG Peng;TIAN Zongmei;WANG Xinghe(Clinical Trial Center for Drugs and Medical Devices,Capital Medical University,Beijing 100038,China;Information Center,Capital Medical University,Beijing 100038,China;Phase Ⅰ Clinical Trial Center3,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药物及医疗器械临床试验机构,北京100038 [2]首都医科大学附属北京世纪坛医院信息中心,北京100038 [3]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,北京100038

出　　处：《中国医药导刊》2024年第6期551-554,共4页Chinese Journal of Medicinal Guide

基　　金：北京市科学技术委员会“北京医药临床试验服务后补助工作”经费资助项目(2022CROHBZ)。

摘　　要：临床试验质量管理贯穿临床试验的全过程。医疗机构采用电子信息系统管理临床试验已是大势所趋,对临床试验项目的全程实现高效、高质动态过程管理需要不断完善与迭代。按照《药物临床试验质量管理规范》(GCP)要求,临床试验各方“应当识别影响到临床试验关键环节和数据的风险”。本研究从医疗机构视角,分析了在临床试验管理的立项流程、研究人员权限、入组实施管理、数据查阅信息安全及安全性信息上报等方面存在的常见问题,并通过采用临床试验管理系统(CTMS)与医院信息管理系统(HIS)对接的形式,实现数据互通,利用信息化系统在管理实施过程中加强权限管理、数据安全,优化业务流程,并重视安全性报告管理,从而有效提高管理工作效率,降低人为过失,提高临床试验的整体质量,为其他医院实施临床试验信息化管理提供了一个具有参考意义的范例。Quality management should be implemented throughout the whole process of clinical trials.The use of electronic informa⁃tion systems to manage clinical trials in the hospital has become a general trend.The efficient and high-quality dynamic process manage⁃ment requires continuous improvement and iteration.According to the requirements of Good Clinical Practice(GCP),all the parties involved in clinical trials should"identify risks affecting key aspects and data of clinical trials”.This study analyzes the common prob⁃lems in the approval process,researcher authorization,enrollment implementation management,data access information security,and safety information reporting in the clinical trial management from the perspective of medical institutions.By adopting the integration of clinical trial management system(CTMS)and hospital information management system(HIS),data exchange is achieved,and informa⁃tion systems are used to strengthen permission management,data security,optimize administrative processes,and emphasis safety report management,so as to effectively improve management efficiency,reduce risks and errors,improve the overall quality of clinical trials,and provide a reference example for other hospitals to design or update their clinical trial management system.

关 键 词：临床试验 质量管理 信息系统 风险控制 药物临床试验质量管理规范 

分 类 号：R95[医药卫生—药学]