The define.xml is created once (i) SDTM specifications are finalized (ii) SDTM domains are created in .xpt files, (iii) the eCRF has been annotated and (iv) supporting documents have been finalized.

Validation of the define.xml includes:

  • Pinnacle 21 or similar software
  • Visual inspection of the define.xml and verification of functioning links within the document and to external sources

A .pdf version of the define.xml is rendered upon request.