摘要
临床数据交换标准协会(CDISC)是全球性的非营利性标准开发组织,其基于临床研究的共识创建了一套标准体系,主要包括核心标准、数据交换标准、受控术语集和治疗领域标准四大方面,各类标准在研究中的角色不同,贯穿于研究流程的各个环节。伴随着自动化软件的开发,国际监管机构和大型药物研发企业已实现CDISC标准的应用,该标准体系在国内逐渐得到认可和推广,专业技术服务亦正在逐步开展和普及。本文详细介绍了CDISC标准体系下的各类标准及其关系和应用流程,总结国内外应用现状并提出建议,以期为相关研究的标准化建设提供重要参考。
Clinical Data Interchange Standards Consortium(CDISC) is a global non-profit standard development organization.Based on the consensus of clinical research,it has established a set of standard systems,including core standards,data interchange standards,controlled terminology standards,and treatment domain standards.These standards play different roles in research and span various stages of the research process.With the development of automated software,international regulatory agencies and large pharmaceutical companies have implemented the application of CDISC standards.The standard system is gradually gaining recognition and promotion in China,and professional technical services are also being gradually developed and popularized.This article provided a detailed introduction to various standards under the CDISC standard system,including their relationships,and application processes.It summarized the application status at home and abroad and provides suggestions,aiming to provide important references for the standardization of relevant research.
作者
王泽
陈浩
陈佳齐
武睿婕
李紫琳
李雨菲
张媛
吕明
WANG Ze;CHEN Hao;CHEN Jiaqi;WU Ruijie;LI Zilin;LI Yufei;ZHANG Yuan;LÜMing(Department of Epidemiology and Biostatistics,School of Public Health,Cheeloo College of Medicine,Shandong University,Ji′nan 250012,China;Clinical Epidemiology Unit,Qilu Hospital of Shandong University,Ji′nan 250012,China;Clinical Research Center of Shandong University,Ji′nan 250012,China)
出处
《中国公共卫生》
CAS
CSCD
北大核心
2024年第2期227-233,共7页
Chinese Journal of Public Health
基金
国家重点研发计划项目(2021YFF1201101)。
