Guideline on good pharmacovigilance practices (GVP) – Module VI Addendum I – Duplicate management of suspected adverse reaction reports
✅ GVP Module VI – Addendum I: Duplicate Management of Suspected Adverse Reaction Reports
🔹 Purpose
This Addendum to GVP Module VI provides guidance on how Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) should manage duplicate Individual Case Safety Reports (ICSRs) to ensure accurate signal detection, data integrity, and public health protection.
🔹 Why Is Duplicate Management Important?
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Prevents inflated case counts in databases like EudraVigilance
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Avoids false safety signals
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Enhances data quality and consistency
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Supports accurate benefit-risk assessment
🔹 Types of Duplicates
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True Duplicate: Two or more ICSRs that refer to the same case, based on the same patient and same event.
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Potential Duplicate: Similar cases where it’s uncertain if they refer to the same event.
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Related Cases: Reports involving linked patients or products, but not true duplicates.
🔹 Identification of Duplicates
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Use automated tools (like EudraVigilance duplicate detection)
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Apply manual review for complex scenarios
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Compare fields such as:
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Patient demographics
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Dates
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Product information
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Reporter and sender
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Adverse reactions/events
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🔹 Management Process
For MAHs and NCAs:
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Detect duplicates through automated and manual checks.
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Assess if the case is a true, potential, or non-duplicate.
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Merge or link the duplicates as per applicable system rules (e.g., in EudraVigilance).
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Document the decision and maintain an audit trail.
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Update the narrative and case data appropriately.
🔹 Best Practices
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Assign responsibilities and SOPs for duplicate detection.
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Regularly train staff involved in ICSR processing.
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Continuously improve algorithms and data review processes.
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Ensure compatibility and consistency with EudraVigilance and ICH standards.
🔹 Outcome of Good Duplicate Management
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Improved data reliability
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Reduced workload and confusion
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Better signal quality
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Enhanced regulatory compliance
📌 Summary:
Duplicate case management is critical for pharmacovigilance data accuracy. GVP Module VI Addendum I outlines how MAHs and NCAs should detect, assess, manage, and document duplicates in line with regulatory expectations.
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