Diabetes

Diabetes Therapeutic Area User Guide v1.0

1.0
Release Date: 11 Sep 2014

Version 1.0 of the Diabetes Therapeutic Area User Guide (TAUG-Diabetes) was developed under the CFAST program and the CDISC Standards Development Process. The TAUG-Diabetes describes the most common biomedical concepts relevant to diabetes studies, and the necessary metadata to represent such data consistently with the CDISC standards, such as the SDTM, CDASH and ADaM.

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.

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process. 

Diabetes Therapeutic Area User Guide v1.0 - Supplement for ADaM

1.0
Release Date: 18 Dec 2015

The Analysis Data Model (ADaM) Supplement to version 1.0 of TAUG-Diabetes illustrates using ADaM to create datasets that support analyzing statistical endpoints common to diabetes clinical trials.

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.

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.