Therapeutic Area Standards

Therapeutic Area Standards


Therapeutic Area (TA) Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 30 indications.

CDISC released Therapeutic Area User Guides in the last quarter  for the following disease areas:

Version 1.0 of the Therapeutic Area User Guide for Traditional Chinese Medicine Coronary Artery Disease-Angina (TAUG-TCM-CAD-Angina) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Coronary Artery Disease-Angina and the necessary metadata to represent such data consistently with Controlled Terminology, SDTM, and ADaM.

中医冠心病心绞痛治疗领域数据标准用户指南1.0版(TAUG-TCM-CAD-Angina) 遵照CDISC标准开发程序开发,本指南描述了与冠心病心绞痛相关的最常见的生物医学概念以及呈现此类数据所需的元数据, 并且和受控术语,SDTM,ADaM标准达成统一。

Developed in partnership with CDISC volunteers, Xiyuan Hospital of China Academy of Chinese Medical Sciences, National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), and supported by the Chinese CDISC Coordinating Committee (C3C) and other TCM Institutions in China, TAUG-TCM-CAD-Angina is CDISC’s first standard to be released for Traditional Chinese Medicine as well as the first standard published in both Chinese and English.

TAUG-TCM-CAD-Angina由CDISC志愿者、中国中医科学院西苑医院、美国国立癌症研究所-企业词汇服务部 (NCI-EVS)合作开发,开发过程得到了CDISC中国协调委员会(C3C)和其他中医单位的支持,TAUG-TCM-CAD-Angina是CDISC发布的首个中医治疗领域标准,也是首个以中文和英文两种语言出版的标准。

 

Version 1.0 of the Therapeutic Area User Guide for Nutrition focuses on infant nutrition, food and fluid intake, stool sampling, and questionnaires (specific to clinical studies in nutrition), and includes concepts for adult and pediatric populations. TAUG-Nutrition v1.0 describes the most common biomedical concepts relevant to nutritional studies, and the necessary metadata to represent such data consistently with Terminology, CDASH and SDTM.