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.