CDISC watch: distinguish the roadmap from a released standard

Read status as well as version

The CDISC standards-in-development page, checked on 20 September 2026, lists ADaM and IG v3.0 in development and SDTM v3.0 as resolving public-review comments. It also lists SDTMIG v4.0 with a projected 2027 publication. These entries are a planning snapshot, not a statement that each version is final or required.

Keep a study standards register

Record the model, implementation guide, controlled terminology release and any applicable authority requirements for each study. Assign an owner to assess changes. A newer model and an older implementation guide are not automatically a supported combination.

Assess the impact before migration

Identify affected domains, metadata, derivations, validation rules and reviewer documentation. Decide whether the study should remain on its approved baseline or migrate through controlled change. Recheck the official source at the time of the decision because roadmap dates and statuses can change.

Sources & further reading

• CDISC — Standards in development

Sources checked 20 September 2026. Implementation commentary reflects a practical review perspective; source material may change.