ADaM Derivation, Traceability & Validation
Encode the SAP into analysis-ready data
Build a coherent ADaM suite that implements estimands, endpoints, populations and analysis decisions with reviewable traceability.
Validated SDTM, SAP, analysis specs and study-level conventions
Validated analysis datasets, Define-XML inputs, ARM inputs and ADRG content
Real course content
7 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
ADaM principles in practice
Traceability, one-record-per-analysis-need, analysis flags vs SDTM, and the ADaM specification.
Chapter 1 of 7
ADSL — the subject-level spine
Population flags, treatment variables, baseline characteristics, reference dates — the merge key for everything.
Chapter 2 of 7
BDS I — ADVS (vital signs)
Basic Data Structure anatomy (PARAMCD/PARAM/PARAMN, AVAL/AVALC), baseline and change-from-baseline, analysis flags, derived rows with DTYPE, and SAP-driven visit windowing.
Chapter 3 of 7
BDS II — ADLB (labs)
Multiple PARAMs and units, reference ranges and indicators, shift and CTCAE toxicity grading, baseline handling, and derived parameters.
Chapter 4 of 7
OCCDS — ADAE
The occurrence structure, treatment-emergent flags, SOC/PT coding, occurrence analysis flags, SMQ and customized-query groupings, and ties back to ADSL populations.
Chapter 5 of 7
ADTTE — time-to-event
Event and censor definitions, CNSR/AVAL/STARTDT, analysis parameters, and feeding survival outputs.
Chapter 6 of 7
ADaM define & validation
Value-level metadata, Pinnacle 21 for ADaM, traceability checks, and an ADRG preview.
Chapter 7 of 7