Diabetes Type 1 Therapeutic Area User Guide v2.0 - Pediatrics and Devices Modules

Published Date:

Version 2.0 of the Type 1 Diabetes Therapeutic Area User Guide - Pediatrics and Devices Modules was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to Type 1 Diabetes studies that address Pediatrics and Devices, and the necessary metadata to represent such data consistently with Terminology CDASH SDTM and ADaM.

Version 2.0 contains the addition of analysis concepts relevant to Type 1 Diabetes – Pediatrics and Devices as well as corrections to some minor inconsistencies in v1.0.

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.

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

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