A Preliminary Discussion of Application of CDISC Standards in Clinical Research Data Management of New Traditional Chinese Medicine
10.3969/j.issn.1005-5304.2016.01.002
- VernacularTitle:中药新药临床研究数据管理应用CDISC标准的初步探讨
- Author:
Fang LU
;
Qingna LI
;
Yang ZHAO
;
Rui GAO
- Publication Type:Journal Article
- Keywords:
clinical research of new traditional Chinese medicine;
clinical data interchange standards;
data management
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2016;(1):9-14
- CountryChina
- Language:Chinese
-
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.
