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.
Click on the titles below for complete guidelines
Table of contents
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
VI. Add I.4.3. Sending
nullifications
VI. Add I.4.4. Duplicates
received from the same sender organisation
EMA GVP Module 6, Addendum I: