Guideline on good pharmacovigilance practices (GVP) Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions:
Introduction:
Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal detection. The monitoring process is facilitated by statistical summaries of the information received for each “drug-event” combination over defined time periods. To limit the chances of failing to detect a signal and to ensure that the processes in place are controlled and predictable in terms of resources required, it is recommended that these summaries are produced in a routine periodic fashion. For the same reasons, when possible, the criteria for selecting “drug-event” combinations (DECs) for further investigation should be objectively defined. The aim of this Addendum to GVP Module IX on signal management is to describe components of an effective system for routine scanning of accumulating data focusing on components that have been proved to be effective. It does not give details of particular implementations of such system because these may be influenced by a number of factors that differ between databases. For those interested in the specific implementation developed for use in EudraVigilance other guidance is available. In common with other GVP documents, the information given herein is guidance on good practice to assist in ensuring compliance with Commission Implementing Regulation (EU) No 520/20122. Other methods may also satisfy this requirement.
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Table of contents
IX. Add I.2. Statistical methods
IX. Add I.2.1. Disproportionate reporting
IX. Add I.2.1.1. Considerations related to performance of signal
detection systems
IX. Add I.2.2. Increased ICSR reporting frequency
IX. Add I.3. Methods aimed at specific groups of adverse events
IX. Add I.3.1. Designated medical events
IX. Add I.4. Methods aimed at specific patient populations
IX. Add I.4.1. Paediatric population
IX. Add I.4.2. Geriatric population
IX. Add I.5. Methods aimed at specific circumstances of medicines use
EMA GVP Module 9, Addendum I:
