Safety Database Reconciliation
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The periodic comparison of adverse event data held in the clinical database against the cases recorded in the pharmacovigilance safety database, to confirm that every reportable case was captured, correctly classified, and consistently represented in both systems. Discrepancies are investigated and resolved, and the process itself is documented as part of trial quality oversight.
Adverse events typically enter a trial’s data ecosystem through two parallel pathways — routine capture in the eCRF for clinical data management, and, for events meeting reporting criteria, separate and often faster entry into the pharmacovigilance safety database — creating a real risk that the two systems diverge.
Reconciliation frequency and method are pre-specified, usually in a data management plan or safety management plan, and typically compare case counts, seriousness classification, dates, and causality assessment across the two systems for the same underlying events.
Common discrepancy types include a case present in one system but missing from the other, mismatched seriousness or outcome, and date inconsistencies; each is investigated to a documented resolution, since an unreconciled gap can mean a reportable case was never actually reported.
- —Confirms every case meeting reporting criteria is present, consistently, in both the clinical database and the pharmacovigilance safety database.
- —Frequency and method are pre-specified, typically in a data management plan or safety management plan.
- —Common discrepancy types include missing cases, mismatched seriousness classification, and mismatched dates or causality between systems.
- —Reconciliation results and resolutions are documented and are a routine focus of GCP and pharmacovigilance inspections.
ICH E6(R3) GCP; ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Frequently asked questions
What is Safety Database Reconciliation?
The periodic comparison of adverse event data held in the clinical database against the cases recorded in the pharmacovigilance safety database, to confirm that every reportable case was captured, correctly classified, and consistently represented in both systems. Discrepancies are investigated and resolved, and the process itself is documented as part of trial quality oversight.
Which regulations cover Safety Database Reconciliation?
ICH E6(R3) GCP; ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting