Version 1.0 of the Multiple Sclerosis Therapeutic Area User Guide (TAUG-Multiple Sclerosis) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-Multiple Sclerosis describes the most common biomedical concepts relevant to multiple sclerosis, and the necessary metadata to represent such data consistently with Terminology 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.
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:
This project was made possible by the generous support of the National Multiple Sclerosis Society.
The Multiple Sclerosis Outcomes Assessments Consortium (the Critical Path Institute and the National MS Society) use CDISC standards to standardize and analyze MS data to qualify a new measure of disability as a primary or secondary endpoint for future trials of MS therapies