Signal management process

A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.

The signal management process shall include the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action [IR 520/2012 Art 21(1)].

For explanations on active surveillance, see GVP Module VIII.App1.1.1.

See also Signal detection, Signal validation, Signal prioritisation, Individual case safety reports