Built on ongoing discipline
The final pass closes what's left. It isn't the first reconciliation. Cases were compared against SAE reconciliation run throughout conduct, not scrambled together at the end.
What's included
What the final reconciliation confirms
- Every SAE in the safety database matched against its corresponding record in the clinical database, case by case
- Outstanding discrepancies from prior reconciliation cycles run under the SAE reconciliation plan closed and resolved
- Onset dates, seriousness criteria, causality, and outcome compared across both databases for consistency
- Any late or amended reports captured and reflected in both systems before the comparison is finalized
- A documented reconciliation report produced and signed off as a gating item ahead of safety database lock
A documented gate, not a formality
Sign-off here is a named prerequisite for safety database lock, the safety record has to be clean before the database closes.
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