摘要
目的基于受试者的安全权益,方案偏离风险控制和提高临床试验源数据质量的考虑,本院率先探索建立了临床试验管理系统,笔者介绍该系统设计与应用的实践经验。方法通过对临床试验实施过程中各参与角色、要素和风险的管理,搭建系统框架和设计相关功能。结果该系统有效提升本院临床试验源数据质量,保证源数据的可溯源性、完整性、持久性和一致性,使临床试验的管理提质增效。结论依靠传统人工或纸质的模式来控制实施过程中的风险已不能满足目前临床试验的需求,研究中心利用信息技术实现对风险和源数据的把控是必然趋势,探索过程中需要各方沟通协作才能实现共赢。
OBJECTIVE To establish a clinical trial management system for the sake of the safety and rights of the subjects,the control of protocol deviation risk,and the improvement of source data quality of clinical trials,and introduce the practical experience during the design and application of the system.METHODS By managing the multi-participants,elements,and risks involved in the implementation of clinical trials,the system framework was constructed,and relevant functions were designed.RESULTS The system effectively enhanced the quality of clinical trial source data in our institution by ensuring the attributability,completeness,durability,and consistency of source data,and improved the quality and efficiency of clinical trial management.CONCLUSION To control risks during the implementation process depending on traditional manual or paperbased mode can no longer meet the current needs of clinical trials.It is an inevitable trend for the institutions to utilize information technology to manage risks and source data,and it is necessary for multi-participants to achieve a win-win situation by efficient communication and collaboration.
作者
张小琼
刘思佳
王萌萌
方梦玲
吴建才
ZHANG Xiaoqiong;LIU Sijia;WANG Mengmeng;FANG Mengling;WU Jiancai(Clinical Trial Ofice of Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan 430022,China)
出处
《中国药学杂志》
北大核心
2025年第17期1873-1877,共5页
Chinese Pharmaceutical Journal
基金
湖北省卫生健康科研面上项目资助(WJ2023M039)。
关键词
临床试验
信息系统
源数据质量
风险控制
clinical trial
information system
source data quality
risk control
