Every gate cleared first
Lock only happens once final SAE reconciliation and coding are complete and the database is confirmed clean.
What's included
The gates confirmed before lock
- All cases closed, with no open safety queries remaining anywhere in the database
- Final reconciliation confirmed and signed off, per final SAE reconciliation, with the clinical database
- Coding completion verified for every adverse event term against the current MedDRA/WHODrug version
- Lock readiness reviewed against the requirements set out in the Safety Management Plan
- Database locked with edit access removed, so any post-lock change requires a formal, documented amendment
The handoff to CSR drafting
Once locked, the safety record feeds directly into the final safety summary for CSR, with no reconciliation left to do downstream.
← Back to Pharmacovigilance
More in Safety Database