Dear CDISC Community,
CDISC is pleased to announce the following domains for version v4.0 of the SDTMIG are entering the Public Review period:
- Clinical Classifications (CC)
- Disease Response (RS) (as applicable to the split of the domain into Disease Response and Clinical Classifications domains)
The CC Domain was developed to be included in SDTMIG v4.0. The main scope of SDTMIG v4.0 has already undergone Public Review; this domain is part of a small, expanded scope project that will be developed and reviewed separately from SDTMIG v4.0, but published within SDTMIG v4.0. The expanded scope of SDTMIG v4.0 has been undertaken to ensure completeness of SDTMIG v4.0 prior to efforts to move towards digitization of all CDISC standards.
Draft domains:
- Clinical Classifications (CC)
- Detailed changes and links to specific pages can be found here: Clinical Classifications (CC) Changes
- Disease Response (RS)
Conformance Rules and SDTM changes:
- Conformance Rules: RS, CC Domains - Conformance Rules
- Changes to SDTM v3.0 to support the split of the CC from RS are available for review here: Clinical Classifications (CC) - SDTM v3.0 Changes
During this period of Public Review, the Members Only Webinar held to discuss the split of RS and CC has been made publicly available here:
Members-Only Webinar: SDTMIG v4.0: Splitting the RS Domain into RS and CC.
Reviewers are requested to provide comments via JIRA. Detailed instructions on reviewing the document and using the Wiki and JIRA can be found here:
Instructions for Reviewers.
Public Review closes 12 December 2026.
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.