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:
Clostridium Difficile Associated Diarrhea (CDAD) is a major medical and infection control problem, particularly common among the elderly in long-term care or hospital facilities. Version 1.0 of the Therapeutic Area User Guide for CDAD (TAUG-CDAD) describes the most common biomedical concepts relevant to CDAD, and the necessary metadata to represent such data consistently with Controlled Terminology and SDTM.
According to the World Health Organization, Lung Cancer is one of the most common cancers and one of the most common causes of cancer death.Version 1.0 of the Lung Cancer Therapeutic Area User Guide (TAUG-LuCa) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Lung Cancer, and the necessary metadata to represent such data consistently with Controlled Terminology, CDASH, SDTM and ADaM.