Agreed before conduct, not improvised during it
The method and cadence are fixed in writing up front, so reconciliation during the study is a routine, repeatable check rather than a one-off exercise.
What's included
What goes into the plan
- The specific data fields to be reconciled between the safety database and the clinical database defined upfront
- Reconciliation frequency agreed and aligned with the cadence set in the Safety Management Plan
- A discrepancy identification and resolution workflow, with defined owners and turnaround expectations
- Documentation standards set so every reconciliation cycle produces an audit-ready record
- Escalation triggers for discrepancies that affect a reportable event or a regulatory timeline
- The plan reviewed with the sponsor before it feeds into ongoing case processing
Feeds directly into ongoing reconciliation
This plan is the reference document behind every cycle of SAE Reconciliation (Safety DB vs Clinical DB) run during conduct.