Individual skill

cdisc-compliance

Reason about CDISC SDTM and ADaM implementation for regulatory submissions. Use when the user asks about SDTM domain mapping, ADaM dataset design, controlled terminology versioning, define.xml completeness, FDA or PMDA submission requirements, query prioritization by clinical impact, SUPPQUAL usage, or CDISC compliance review. Triggers include "SDTM mapping", "ADaM dataset", "CDISC compliance", "controlled terminology", "define.xml", "FDA submission data", "PMDA submission", "SDTM domain", "ADSL", "ADAE", "ADLB", "BDS structure", "SUPPQUAL", "RELREC", "value-level metadata", "CDISC CT", "regulatory submission data standards", "eCTD datasets", "SDTM 3.3", "ADaM 1.1", "query prioritization", "clinical data review".

skills/cdisc-compliance/SKILL.md

Source commit 4603541c396cdd845dbae554800a65132d12bb63

What was checked

Matches the observed repository HEAD

Yes

Scanner rules are current

Yes

Repository scan complete

No

Skill scan complete

Yes

Observed behavior

Instructions only

Last checked

Nov 11, 2026

These are observations at the recorded commit, not a guarantee of safety. Review the source before running it.

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