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
Slide 1 / 5| Class | Domains (examples) |
|---|---|
| Special purpose | DM (demographics), CO (comments), SE (subject elements), SV (subject visits) |
| Interventions | EX (exposure), CM (concomitant meds), SU (substance use) |
| Events | AE (adverse events), MH (medical history), DS (disposition), DV (deviations) |
| Findings | LB (labs), VS (vital signs), EG (ECG), QS (questionnaires), PE (physical exam) |
| Trial design | TA, TE, TV, TI, TS (trial summary) |
| Relationships | SUPP-- (supplemental qualifiers), RELREC |