Guided Notes

SDTM Fundamentals

SDTM domains and classes (special purpose, interventions, events, findings, trial design), key variables (STUDYID, USUBJID, --SEQ, --TESTCD, VISITNUM), structure and mapping from CRFs.

Domains and classes

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ClassDomains (examples)
Special purposeDM (demographics), CO (comments), SE (subject elements), SV (subject visits)
InterventionsEX (exposure), CM (concomitant meds), SU (substance use)
EventsAE (adverse events), MH (medical history), DS (disposition), DV (deviations)
FindingsLB (labs), VS (vital signs), EG (ECG), QS (questionnaires), PE (physical exam)
Trial designTA, TE, TV, TI, TS (trial summary)
RelationshipsSUPP-- (supplemental qualifiers), RELREC
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