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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


11.1.General aspects of signal detection

A general overview of methods for signal detection and recommendations for their application are provided in the report of the CIOMS Working Group VIII Practical aspects of signal detection in pharmacovigilance; empirical results on various aspects of signal detection obtained from the IMI PROTECT project have been summarised in Good Signal Detection Practices: Evidence from IMI PROTECT. (Drug Saf. 2016;39(6):469-90).


The EU Guideline on good pharmacovigilance practices (GVP) Module IX (Rev 1)- Signal Management defines signal management as the set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems, studies, literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether risks have changed. Signal management covers all steps from detecting signals (signal detection), through their validation and confirmation, analysis, prioritisation and assessment to recommending action, as well as the tracking of the steps taken and of any recommendations made. The Guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions describes the components of an effective signal detection system and lists some of the methodological aspects that have been proved to be effective and that should be considered. Implementation details of such a system are not provided as they may be database dependent.


The FDA’s Guidance for Industry-Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment provides best practice for documenting, assessing and reporting individual case safety reports and case series and for identifying, evaluating, investigating and interpreting safety signals, including recommendations on data mining techniques and use of pharmacoepidemiological studies.



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