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.

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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.

Computational algorithms can also be stored within define.xml framework.