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