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.