Checked continuously, not just at lock
Reconciliation runs throughout conduct, catching mismatches while they're still easy to trace back to source.
What's included
What reconciliation checks
- Line listings from the safety database compared against SAE records in the clinical database on an agreed cadence
- Discrepancies in event terms, onset dates, seriousness criteria, and outcome flagged for follow-up with the site or PV team
- Missing events identified in either direction — captured in one system but not yet reflected in the other
- Resolution tracked to close-out, with each reconciled discrepancy documented for the audit trail
- A final reconciliation pass run ahead of database lock to confirm both systems agree before data is finalized
Coordinated with pharmacovigilance
Works directly with pharmacovigilance to confirm every SAE is captured consistently in both systems.