Submission Package

The submission package includes:

  • SDTM specifications
  • SDTM domains in .xpt format
  • SDTM Reviewer’s Guide
  • SDTM domain programs (if applicable)
  • SDTM define.xml (in .pdf format if requested)
  • List of all findings per CDISC/FDA validation rules
  • Blank and annotated CRF
  • All other supporting documents, e.g. complex algorithms document