The define.xml is created once (i) ADaM specifications are finalized (ii) ADaM datasets are created in .xpt files, (iii) TLF output has been finalized, (iv) Reviewer’s Guide has been finalized and (v) other supporting documents are available.

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.