Traditional Chinese Medicine - Coronary Artery Disease-Angina Therapeutic Area User Guide v1.0
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.
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 Chinese and English.
TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2