Standards in Development

Foundational

For current versions of the standards, please visit the Standards Home Page.


Standard Sort descending Release Notes Projected Publication
ADaM and IG v3.0

In Development

2026
ADaM Oncology Examples v1.0

Resolving Public Review Comments

2024
CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1

Resolving Public Review Comments

2024
SDTM v3.0

In Development

2025
SDTMIG v4.0

In Development

2025
SENDIG v4.0

In Development

2025

Therapeutic Areas

For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.


Therapeutic Area Sort descending Release Notes Projected Publication
Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0

Version 1.0 of the Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-DMD describes the most common biomedical concepts relevant to Duchenne Muscular Dystrophy, and the necessary metadata to represent such data consistently with Terminology and  SDTM.

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.

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

The specifications comprise five worksheets in an Excel workbook:

  • Read Me – Information on how to read the other worksheets
  • Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  • Known Issues – A list of modeling issues noted in the TAUG
  • Domains – Domains used and their status in different versions of the SDTMIG
  • Variables – Variables used and their status in different versions of the SDTM
  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
2024