应用EpiData软件创建临床研究电子数据库  

Establishment of an electronic database for clinical study by EpiData software

作　　者：王瑞平 李斌 WANG Ruiping;LI Bin(Clinical Research&Innovation Center,Shanghai Skin Disease Hospital,Shanghai 200443,China)

机构地区：[1]上海市皮肤病医院临床研究与创新转化中心,上海200443

出　　处：《上海医药》2023年第13期72-76,81,共6页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市卫生健康委员会卫生行业临床研究专项(202240371);上海申康医院发展中第二轮促进市级医院临床技能与临床创新三年行动计划——研究型医师创新转化能力培训项目(SHDC2022CRS053);上海市皮肤病医院引进人才科研基金项目(2021KYQD01);上海人才发展基金资助项目(2021SHRCFZ01);上海市医院协会医院管理研究基金项目(X2022117)。

摘　　要：临床研究的实践中,考虑到大多数临床研究工作者的项目经费问题,往往不能应用临床试验电子数据采集(EDC)数据库开展临床研究数据录入和管理等工作。因此,EpiData这种开源、免费的数据库软件便“脱颖而出”,受到越来越多临床研究团队的青睐和应用。本文从EpiData软件简介开始,分别介绍建立电子数据库所用到的变量类别和设置方式,并以建立EpiData数据库过程的先后顺序,讲解“调查表(QES)文件”“数据(REC)文件”“核查(CHK)文件”的创建方法,由此来详细介绍如何应用EpiData软件创建临床研究电子数据库。In the practice of clinical research,most researchers are often unable to use electronic data capture(EDC)databases for clinical research data entry and management due to the financial constraints of their projects.As a result,EpiData,an open-source and free database software,has become more and more popular and been used by clinical research teams.The variable categories and settings used to build the electronic database were introduced starting from the introduction of EpiData software,followed by the sequence of the process of establishing an EpiData database and the creation methods of the“questionnaire(QES)file”,“record(REC)file”,and“check(CHK)file”,and finally how to create an electronic database for clinical studies was introduced in detail.

关 键 词：EPIDATA软件 临床研究 电子数据库 

分 类 号：R-3[医药卫生] G312[文化科学]