Version 1.0 of the Type 1 Diabetes Therapeutic Area User Guide: Exercise and Nutrition Modules was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Type 1 Diabetes trials involving exercise and nutrition, and the necessary metadata to represent such data consistently with Terminology, CDASH, SDTM and Define-XML.
Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertain to specific indications within disease areas. 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.
This TAUG covers the following concepts:
- Exercise Fitness and Strength
- Types of Activity and Activity Devices
- Nutrition
- Questionnaires Ratings and Scales of relevance to Type 1 diabetes exercise and nutrition trials
The Type 1 Diabetes - Exercise and Nutrition 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
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