Submission Package

The submission package includes:

  • ADaM specifications
  • ADaM domains in .xpt format
  • ADaM Reviewer’s Guide
  • ADaM programs for specific analyses (if applicable)
  • ADaM define.xml (in .pdf format if requested)
  • List of all findings per CDISC/FDA validation rules
  • Output for specific TLFs in .pdf format
  • Statistical Analysis Plan
  • All other supporting documents, e.g. derivation/algorithm document