Version 1.0 of the Crohn's Disease Therapeutic Area User Guide (TAUG) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Crohn's Disease trials, and the necessary metadata to represent such data consistently with Terminology, CDASH, SDTM , and ADaM.
Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards and TAUGs specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
Crohn's Disease TAUG v1.0 covers the following concepts:
- Disease Classification
- Prior, Baseline, and On-study Medications and Procedures Module
- Endoscopy Assessments
- Cross-sectional Imaging Assessments
- Histopathology of Biopsies
- Biomarkers Related to Crohn's Disease
- Crohn's Disease Analysis
- Questionnaires Ratings and Scales of relevance to Crohn's Disease
The Crohn's Disease TAUG would not have been possible without the financial support and dedication of subject matter experts from our partner The Leona M. and Harry B. Helmsley Charitable Trust .
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