中国中医药信息杂志Issue(1)：9-14,6.DOI:10.3969/j.issn.1005-5304.2016.01.002
中药新药临床研究数据管理应用CDISC标准的初步探讨
A Preliminary Discussion of Application of CDISC Standards in Clinical Research Data Management of New Traditional Chinese Medicine
摘要
Abstract
In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.关键词
中药新药临床研究/临床数据交换标准/数据管理Key words
clinical research of new traditional Chinese medicine/clinical data interchange standards/data management分类
医药卫生引用本文复制引用
陆芳,李庆娜,赵阳,高蕊..中药新药临床研究数据管理应用CDISC标准的初步探讨[J].中国中医药信息杂志,2016,(1):9-14,6.基金项目
中医药行业科研专项(201107006)；国家科技重大专项-重大新药创制(2012ZX09303-010-002) （201107006）
