Guided Notes

Define-XML & the Submission Package

What goes into a regulatory data package (SDTM, ADaM, Define-XML, aCRF, reviewer's guides), Define-XML content, conformance validation and common technical rejection pitfalls.

The data package

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ComponentPurpose
SDTM datasets (XPT)Tabulated collected data
ADaM datasets (XPT)Analysis datasets
Define-XML (SDTM and ADaM)Metadata: datasets, variables, codelists, origins, derivations
Annotated CRF (aCRF)CRF PDF showing SDTM variable for each field
Reviewer's guides (cSDRG, ADRG)Explain data, conformance issues and decisions
Analysis programs (if requested)How results were produced
← ADaM & Analysis Traceability