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Breast Cancer

Breast Cancer Therapeutic Area User Guide v1.0

Release Date: 16 May 2016

Version 1.0 of the Breast Cancer Therapeutic Area User Guide (TAUG-BrCa) was developed under the CFAST program and the CDISC Standards Development Process. The TA User Guide-BrCa describes the most common biomedical concepts relevant to Breast Cancer, and the necessary metadata to represent such data consistently with CDISC standards, such as CDASH, SDTM, and ADaM.

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.