RestrictedHealthcare

CDISC

Clinical Data Interchange Standards Consortium

Suite of standards (CDASH, SDTM, ADaM) for clinical trial data. FDA-endorsed for regulatory submissions.

clinical-trialsfdaregulatory
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Class Hierarchy

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Use Cases

When and where you'd use this ontology in practice.

01

FDA regulatory submission data formatting

02

Clinical trial data collection (CDASH)

03

Study data tabulation (SDTM)

04

Statistical analysis datasets (ADaM)

Details

Maintained By
CDISC
License
Restricted
CDISC IP Policy 003 (member-scoped)CDISC-Policy-003

Royalty-free but scoped to CDISC Participants and explicitly NON-SUBLICENSABLE, deferring to per-format website terms. Not open.

Verified against the licence text on 2026-08-07.

Category
Healthcare

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