SDTM Mapping, Build & Submission Package
Turn heterogeneous sources into reviewer-friendly tabulation data
Specify, program, validate and document a complete SDTM package, including complex timing and non-CRF sources.
Locked or governed source data, aCRF and SDTM metadata specification
Validated SDTM XPT package, Define-XML inputs, aCRF and SDRG content
Real course content
7 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
From aCRF to SDTM — the mapping mindset
Reading the annotation, source-to-target specs, one-to-one / split / combine mappings, origin and derivation.
Chapter 1 of 7
Special-purpose & demographics: DM
Building DM: age, sex, race, arm, RFSTDTC, epoch and element linkage, and common pitfalls.
Chapter 2 of 7
Interventions domains: EX, CM, (EC)
Exposure and dosing, concomitant meds with WHODrug, interventions timing — a worked build in SAS & R.
Chapter 3 of 7
Events domains: AE, MH, DS
Adverse events with MedDRA, medical history, disposition and reasons, and the seriousness/severity/causality qualifiers.
Chapter 4 of 7
Findings domains: LB, VS, EG
Labs with standard and original units, vital signs, ECG, baseline flags, and the findings structure at scale.
Chapter 5 of 7
Trial-design & relationship datasets
TA, TE, TV, TS, SUPPQUAL and RELREC — and why trial-design domains matter to reviewers.
Chapter 6 of 7
Validating SDTM
Pinnacle 21 checks, reject vs warning vs info, building a define-ready dataset, and fixing common findings.
Chapter 7 of 7