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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