The Serious Adverse Event Reconciliation Process Checklist

A Checklist that describes what to do, by whom and what difficulties to be expected in various scenarios during the Serious Adverse Event reconciliation process.

Dedicated to all Clinical Research professionals who are involved in Safety Data Management operations. We hope that this checklist help you better plan and manage the serious adverse event reconciliation process while maintaining quality and compliance.

TABLE OF CONTENT

INTRODUCTION p.4
WHY SAE (SERIOUS ADVERSE EVENT) RECONCILIATION p.4

THE SERIOUS ADVERSE EVENT RECONCILIATION PROCESS p.5

✓ Retrieve and compare data
✓ Review the discrepancies
✓ Resolve the discrepancies
✓ Update database

4 DATAPOINTS TO RECONCILE p.6

✓ Data points that must be identical
✓ Data points that must be consistent

5 SAE RECONCILIATION PROCESS CHECKLIST p.7

✓ Reconciliation of SAEs missing in the clinical database
✓ Reconciliation of SAEs missing in the safety database
✓ Reconciliation of inconsistent or missing SAE related data points
✓ Reconciliation of SAE Preferred Term (PT) inconsistency

6 MOST FREQUENTLY FACED DIFFICULTIES IN SERIOUS ADVERSE EVENT RECONCILIATION PROCESS p.8

✓ Data-related difficulties
✓ Time-related difficulties
✓ Process-related difficulties
✓ Compliance-related difficulties

7 HOW eRECONCILIATION® HELPS p.9

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Clinical Safety Glossary

A list of terms and definitions related to Serious Adverse Events, adverse event data management and safety and clinical databases SAE Reconciliation.

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Pharmacovigilance Regulations

The quality of safety data collection and reporting is paramount to the establishment of a drug safety profile. Here are helpful links to the EMA and FDA regulations addressing those concerns.

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The Serious Adverse Event Reconciliation Process Checklist

A Checklist that describes what to do, by whom and what difficulties to be expected in various scenarios during the Serious Adverse Event reconciliation process.

Dedicated to all Clinical Research professionals who are involved in Safety Data Management operations. We hope that this checklist help you better plan and manage the serious adverse event reconciliation process while maintaining quality and compliance.

TABLE OF CONTENT

Download Your SAE Reconciliation Process Checklist (9 Pages)