Guideline on good pharmacovigilance practices (GVP) Module VI Addendum I – Duplicate management of suspected adverse reaction reports:

VI. Add I.1. Introduction:

Duplicate case reports of suspected adverse reactions can pose significant problems for analysing signals arising from pharmacovigilance databases, both artificially inflating and masking signals of disproportionate reporting (see GVP Module IX Addendum I). The applicable reporting rules cannot avoid duplicate reporting. Databases should therefore be routinely screened to detect and eliminate duplicate cases and the European Medicines Agency (the ‘Agency’), competent authorities in Member States and marketing authorisation holders shall all collaborate in the detection and elimination of duplicates in the Eudra Vigilance database [Articles 107(5) & 107a(3) of Directive 2001/83]. The guidance in this document proposes methods for detecting, confirming and managing duplicate cases suitable for organisations receiving pharmacovigilance data in various different formats and describes methods for stakeholders to collaborate with the Agency in the detection and management of duplicate cases. This guidance is part of the good pharmacovigilance practices (GVP) and an Addendum to GVP Module VI – Management and reporting of adverse reactions to medicinal products.

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Table of contents

VI. Add I.1. Introduction

VI. Add I.2. General aspects of duplicate cases

VI. Add I.3. Detection of duplicate cases

VI. Add I.3.1. What to do if possible duplicates in Eudra Vigilance have been detected

VI. Add I.3.2. Confirmation of duplicates cases

VI. Add I.4. Management of duplicates cases

VI. Add I.4.1. Process of managing duplicates detected during periodic screening

VI. Add I.4.1.1. Allocation of a master case

VI. Add I.4.1.2. Creation of a master case

VI. Add I.4.2. Process maps and descriptions for allocation or creation of a master case