摘要
目的研究并总结我院面向临床研究的真实世界数据治理实践与经验,提出相关思考与建议。方法梳理我院面向临床研究的真实世界数据治理实践过程,并介绍我院数据治理多项应用成果。结果我院建立了多个临床业务信息系统的T+1备份库,并进行多源异构数据采集;建立临床研究通用数据模型(Common Data Model,CDM),并基于CDM进行数据整合、处理和质控。基于真实世界数据的治理实践,我院建设了全院级临床研究大数据平台、多种专病/专科数据库和智能临床试验创新系统等应用系统。结论面向临床研究的医院真实世界数据治理实践应制定符合医院实际的通用数据集模型,规范医院数据采集模式,建立全生命周期数据质控体系;制定数据的分级分类标准及授权管理机制,建立数据应用管理制度,完善和丰富多样化、精准化的数据服务;注重培养医疗大数据复合型人才。
Objective To study and summarize the practice and experience of real-world data governance for clinical research,and put forward relevant suggestions.Methods The real-world data governance practice for clinical research of our hospital was elaborated,and the achievements of data governance were introduced.Results Several T+1 backup databases of clinical information system were set up for multi-source heterogeneous data collection.Common data model(CDM)for clinical research was developed,and data integration,processing and quality control was conducted based on it.Based on the practice of real-world data governance,our hospital established a hospital-wide clinical research big data platform,a variety of specialty databases,and an intelligent clinical trial innovation system.Conclusion In order to improve the real-world data governance system for clinical research,we should design a common data model based on the actual condition of the hospital,standardize the data collection mode,establish the full life cycle data quality control system;develop data classification standard and authorization mechanism,set up data use management system,improve and diversify the data services,and pay attention to train interdisciplinary talents of medical big data.
作者
吴燕秋
梁公文
王天兵
WU Yan-qiu;LIANG Gong-wen;WANG Tian-bing(Peking University People’s Hospital;Ministry of Education Engineering Research Center for Mobile Digital Hospital System)
出处
《医院管理论坛》
2021年第11期84-86,76,共4页
Hospital Management Forum
基金
基地配套—移动数字医院系统教育部工程研究中心,编号:2194000015。
关键词
临床研究
真实世界研究
医院
数据治理
Clinical research
Real-world research
Hospital
Data management
