IX.B.1. Sources of data and information

Signals can arise from a wide variety of data sources. This potentially includes all scientific information concerning the use of medicinal products and the outcome of the use, i.e. quality, non-clinical and clinical data (including pharmacovigilance and pharmacoepidemiological data).

Common sources for signals include spontaneous reporting systems, active surveillance systems, studies (see The Rules Governing Medicinal Products in the European Union, Volume 10 (9) , GVP Module VIII) and the scientific literature reporting such data. Guidance on the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the EU can be found in GVP Module VI.

Signal detection is often based on the periodic monitoring of databases of suspected adverse reactions, which can vary in size or remit, e.g. marketing authorisation holder databases, national databases, EudraVigilance, the database of the WHO Programme for International Drug Monitoring (VigiBase). This module focusses mainly on signals originating from the monitoring of data from spontaneous reporting systems, however all relevant sources should be considered during signal management.