The serious adverse event (SAE) database should be reconciled against the clinical trial database prior...

SAE reconciliationmust becompleted before database lock or closureto ensure all safety data are consistent between theclinical databaseand thepharmacovigilance (safety) database.

According to theGCDMP (Chapter: Safety Data Handling and Reconciliation), SAE reconciliation involves verifying that all adverse events reported in the clinical trial database are also captured and accurately recorded in the safety system (and vice versa). This is essential to confirm thatno SAE is missing, misclassified, or inconsistently dated or codedbetween the two systems.

Performing this reconciliation before database lock ensures that any discrepancies are corrected, and both databases reflect consistent, verified information for regulatory submission. Conducting this after closure (or only at audit time) would risk data inconsistencies in the final submission datasets.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: SAE Reconciliation, Section 6.1 – Timing and Procedures for Reconciliation

ICH E2A/E2F – Clinical Safety Data Management: Definitions and Standards

FDA Guidance for Industry: E2A – Clinical Safety Data Management: Processing Standards for Safety Reports