Standards
NoteStandards used in this portfolio
This page documents the current released CDISC SDTM standards used to build the SDTM examples in this portfolio.
These versions align with the example datasets, specs, and metadata snapshots included in this repo.
Current released versions (SDTM)
| Standard / Artifact | Latest released version | Published | Why it matters |
|---|---|---|---|
| SDTM (Model) | v2.0 | 2021-11-29 | Defines SDTM classes, structure, and core variables |
| SDTMIG (Human Clinical Trials) | v3.4 | 2021-11-29 | Implementation guidance for domains, assumptions, and examples |
| SDTM & SDTMIG Conformance Rules | v2.0 | 2021-11-29 | Validation rule set used by conformance tools |
| SDTM Metadata Submission Guidelines (SDTM-MSG) | v2.0 | 2021-03-30 | Guidance for SDTM submission metadata/package expectations |
| SDTM Controlled Terminology (NCI EVS) | 2025-09-26 | 2025-09-26 | Terminology package date used for codelists and controlled values |
Official references (source of truth)
- SDTM v2.0 — https://www.cdisc.org/standards/foundational/sdtm/sdtm-v2-0
- SDTMIG v3.4 — https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-4
- SDTM & SDTMIG Conformance Rules v2.0 — https://www.cdisc.org/standards/foundational/sdtmig/sdtm-and-sdtmig-conformance-rules-v2-0
- SDTM-MSG v2.0 — https://www.cdisc.org/standards/foundational/sdtm/sdtm-metadata-submission-guidelines-v2-0
- Controlled Terminology landing page — https://www.cdisc.org/standards/terminology/controlled-terminology
- NCI EVS SDTM terminology downloads — https://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.html
Portfolio conventions (how these are applied)
- Mapping baseline: SDTM examples assume SDTM v2.0 + SDTMIG v3.4.
- Terminology baseline: values align to the CT package date listed above.
- Traceability: key assumptions and mapping decisions are documented to support QC and review.
- Submission awareness: always confirm required versions per sponsor/regulatory expectations for your submission.
TipMaintenance note
Controlled Terminology updates more frequently than SDTM/SDTMIG.
When CT updates, change the CT date in the table (and optionally add a changelog entry).
Last updated: 2026-02-14