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.