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Hepatitis C

Chronic Hepatitis C Therapeutic Area User Guide v1.0

1.0
Release Date: 8 May 2015

Version 1.0 of the Chronic Hepatitis C Therapeutic Area User Guide (TAUG-CHCV) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-CHCV describes the most common biomedical concepts relevant to chronic hepatitis C, and the necessary metadata to represent such data consistently with the CDISC standards, such as the 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.