Diabetes Type 1 Therapeutic Area User Guide - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes

Published Date:

Version 1.0 of the Type 1 Diabetes Therapeutic Area User Guide: Screening, Staging and Monitoring for Pre-Clinical T1D Modules was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Type 1 Diabetes trials involving Screening, Staging and Monitoring and the necessary metadata to represent such data consistently with Terminology, CDASH, SDTM, ADaM and Define-XML.

The Therapeutic Area User Guide covers the following concepts:

  • Islet Autoantibodies
  • Polygenic Risk Score
  • T1D Staging
  • History of Viral Infections
  • Microbiome
  • Questionnaires Ratings and Scales of relevance to Type 1 diabetes Screening, Staging and Monitoring for Pre-Clinical T1D trials

This Therapeutic Area User Guide 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

  1. https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
  2. https://www.pmda.go.jp/english/review-services/reviews/0002.html