Author a Define-XML v2.1 file describing SDTM datasets for an FDA regulatory submission

Verified steps

1. Use Define-XML version 2.1 (the current version as of 2025, with Define-XML v2.1.10 released October 2025) as required by FDA's Study Data Technical Conformance Guide for NDA/BLA/IND submissions
2. For each SDTM dataset (domain), create an ItemGroupDef element with the Name attribute matching the SAS dataset name (e.g., DM, AE, LB), the Domain attribute, and IsReferenceData set to Yes for SUPP-- datasets
3. For each variable in each domain, create an ItemDef element specifying: OID, Name, DataType, Length or SignificantDigits, Label, and Origin (e.g., CRF, Derived, Assigned, Protocol) along with the controlled terminology reference (CodeListRef) for coded variables
4. Include the leaf element in ItemGroupDef pointing to the physical dataset file (XPT or SAS) via the xlink:href attribute, and specify the ArchiveLocationID linking to the external file location
5. Add the AnnotatedCRF and SupplementalDoc leaves in the GlobalVariables section to reference the annotated CRF PDF and reviewer's guide, as required in FDA submission packages
6. Validate the completed Define-XML file using Pinnacle 21 Community (or Enterprise) to check for rule violations against the FDA's SDTM Implementation Guide and the Define-XML specification before final packaging