Therapeutic Area Standards

Therapeutic Area Public Review

New Draft Diabetic Kidney Disease v1 Now Available for Public Review – Comments Due 9 August 2016

The CDISC Therapeutic Area Data Standards User Guide for Diabetic Kidney Disease (TAUG-DKD) Version 1 is now available for public comment. The TAUG-DKD describes the most common clinical concepts relevant to studies of Diabetic Kidney Disease. This guide shows examples of how these concepts are represented in the Clinical Data Acquisition Standards Harmonization (CDASH), the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM).

 To view the user guide: TAUG-DKD

 You will need to log in or register for the CDISC Wiki to review the Read Me and provide comments.  


 

New Draft Major Depressive Disorder TA User Guide v1 Now Available for Public Review – Comments Due 8 August 2016

The CDISC Therapeutic Area Data Standards User Guide for Major Depressive Disorder (TAUG-MDD) Version 1 is now available for public comment. The TAUG-MDD describes the most common clinical concepts relevant to studies of Major Depressive Disorder. This guide shows examples of how these concepts are represented in the Clinical Data Acquisition Standards Harmonization (CDASH), the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM).

 To view the user guide: TAUG-MDD

 You will need to log in or register for the CDISC Wiki to review the instructions and provide comments.  


 

New Draft Kidney Transplant Therapeutic Area Standard User Guide v1 Now Available for Public Review – Comments Due 01 August 2016. 

The Draft Kidney Transplant Therapeutic Area Standard User Guide v1 is now available for public comment. The purpose of this TAUG-KT is to describe how to use CDISC standards to represent data pertaining to kidney transplant studies. This first version (v1.0) focuses on studies of therapeutic interventions to prevent kidney transplant rejection in adult recipients. This guide focuses on the key assessments and donor/recipient characteristics required to match donors with recipients, and to monitor post-transplant outcomes.

 To view the user guide: TAUG-KT

 You will need to log in or register for the CDISC Wiki to review the instructions and provide comments.  

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CFAST Therapeutic Area Standards Program

The Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health.

 

CFAST partners include TransCelerate BioPharma Inc. (TCB), the U.S. Food and Drug Administration (FDA), and the National Cancer Institute – Enterprise Vocabulary Service (NCI-EVS), with participation and input from additional organizations. For more information on the CFAST relationship, please visit the CFAST Collaboration page

 

Current CFAST Project Status (Click on a project name to view description)

 

CFAST Program Overview

 

 

 

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