# SDTM Define.xml Documentation Report

## File Metadata
- **Define-XML Version**: 2.0
- **ODM Schema Version**: 1.2.2
- **Source File**: 04_sdtm/define.xml

## Content Summary
- **ItemGroupDefs (Domains)**: 22
  - Special Purpose: DM, SV, SE
  - Events: AE, DS, MH
  - Interventions: CM, EX
  - Findings: LB, QS, SC, VS
  - Trial Design: TA, TE, TI, TS, TV
  - Relationship: RELREC
  - Supplemental: SUPPAE, SUPPDM, SUPPDS, SUPPLB
- **ItemDefs (Variables)**: 539
- **CodeListDefs**: 388

## Controlled Terminology Sources
- MedDRA Version: 8.0
- CDISC Submission Values: SDTM IG 3.1.2
- Study-specific codelists: Treatment arms, Visit codes, Test codes

## Compliance
- Standard: Define-XML 2.0
- SDTM Implementation Guide: 3.1.2
- Pinnacle 21 validation: Referenced in validation framework

## Cross-Reference with SDTM_Specifications.md
- All 22 domains in define.xml match specification inventory
- Variable-level metadata consistent between define.xml and specifications
- Codelist references aligned with P21 format specifications

## Notes
- Define.xml uses ODM v1.2.2 schema (differs from ADaM define.xml which uses v1.3.2)
- Supplemental qualifiers use standard RELID/RDOMAIN/IDVAR/QNAM/QVAL structure
