Multiple Sclerosis Therapeutic Area User Guide v1.0

Published Date:

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

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:

  • Read Me – Information on how to read the other worksheets
  • Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  • Known Issues – A list of modeling issues noted in the TAUG
  • Domains – Domains used and their status in different versions of the SDTMIG
  • Variables – Variables used and their status in different versions of the SDTM

This project was made possible by the generous support of the National Multiple Sclerosis Society.