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
Slide 1 / 5| Component | Purpose |
|---|---|
| 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 |