Standards and versions

Model 2.0IG 3.4Content 1.0.0Curated educational coverage

Four dimensions, different jobs

SDTM model 2.0: The conceptual model used as a teaching context.
SDTMIG 3.4: The separately identified implementation guide context.
Terminology release: None bundled. Links-only mode; no CT compliance claimed.
Content 1.0.0: The version of ClinDevLab's original explanations and synthetic fixtures.

Curated does not mean complete

Six domains and 44 selected variable lessons introduce useful engineering questions. They do not reconstruct official domain specifications. Example JSON types describe our examples, not normative SDTM types.

Corrections and stable references

Version-specific domain URLs remain explicit. Material corrections require a documented content revision and review of the source trail; a future release must not silently overwrite this teaching profile. Source access dates record when information was inspected, not a promise of current regulatory applicability.

Education is not validation

Example checks establish internal consistency only. Regulatory suitability depends on the actual submission context and authoritative requirements. Consult official sources and qualified reviewers for those decisions.

Follow the source

Original ClinDevLab explanations. Publisher material is linked, not reproduced. Reviewed 8 October 2026.

SDTM 2.0https://www.cdisc.org/standards/foundational/sdtm/sdtm-v2-0 · CDISC · 2.0 · accessed 2026-10-08
SDTMIG 3.4https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-4 · CDISC · 3.4 · accessed 2026-10-08
Study Data Standards Resourceshttps://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources · FDA · accessed 2026-10-08