摘要
规范的临床研究数据库的构建及管理可提高研究数据的质量。本文重点介绍了构建临床研究数据库常用的数据标准/规范、数据库建立工具、管理流程和常见问题,并探索了数据库跨库链接机制,强调了数据安全和个人信息保护,以期为研究者开展临床研究项目提供系统依据和原则性指导。
The construction and management of standardized clinical research database can improve the quality of research data.This review focused on the common data standards/specifications,tools for establishing database,management precedure and common problems in the construction of clinical research databases,explored the cross-database linking mechanism,and emphasized the data security and personal information protection,to provide basis and guidance for researchers to carry out clinical researches.
作者
朱之恺
黄馨莹
姜勇
ZHU Zhikai;HUANG Xinying;JIANG Yong(National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Beijing Advanced Innovation Center for Big Data-Based Precision Medicine(Beihang University&Capital Medical University),Beijing 100191,China)
出处
《中国卒中杂志》
2022年第1期36-42,共7页
Chinese Journal of Stroke
基金
国家重点研发计划“重大慢性非传染性疾病防控研究”重点专项(2018YFC1311703)。
关键词
临床研究
数据库
构建
管理
数据安全
Clinical research
Database
Construction
Management
Data security
