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  • Protocol finalization
  • CRF development
  • Database design and UAT
  • Data validation, programming and UAT
  • First patient first visit
  • Last patient last visit
  • Last CRF/data element received/entered
  • Last query/discrepancy form received/completed
  • Final SAE reconciliation completed
  • Medical coding completed and approved
  • Interim analysis, when applicable
  • Database audit
  • Database lock
  • Study data and documentation archiving

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