Information sharing on the content of SDTM in a more or less human-readable manner led to introduction of Define.xml, which – in short – contains all SDTM data AND metadata in XML-format. Further advantage of Define.XML: Content can be checked (validated) with define.XML checker programs (e.g. http://www.pharmasug.org/proceedings/2013/AD/PharmaSUG-2013-AD19.pdf).
The Standard content of define.XML is:
- Data Metadata (TOC)
- Variable Metadata
- Variable Value Level Metadata
- (Computational Algorithms)
- Controlled Terminology/Code Lists
- Annotated CRF
- Optional: Supplemental Data Definition Document.