DB Transfers – DB Lock

SCiAN can provide interim and final database transfers to the Sponsor upon request.  Formats for data transfer include: Excel, ASCII or SAS transport files.

For final database lock, the following steps are completed:

  • All required eCRFs have been entered
  • All eCRFs have been validated by online edit checks
  • All eCRFs have been SDV’d
  • Medical coding has been completed
  • SAE reconciliation has been performed
  • Central safety lab transfers have been reconciled
  • All queries have been resolved and the resolutions applied
  • All Data Reviews completed (if applicable)
  • All eCRFs have been reviewed / signed by PIs
  • All CRFs have been locked (no edit access), and database has been exported into SAS or equivalent database.