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 Terminology, CDASH, and SDTM.
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.
Public Review Comments
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
The specifications comprise five worksheets in an Excel workbook:
|Chronic Hepatitis C Therapeutic Area Data Standard User Guide v1||6.56 MB|
|TA Spec-Hep C v1||24.22 KB|
|CDISC Chronic Hepatitis C v1 Public Review Comments||60.08 KB|