Signal

Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action [IR 520/2012 Art 19(1)].

New aspects of a known association may include changes in the frequency, distribution (e.g. gender, age and country), duration, severity or outcome of the adverse reaction.

For the purpose of monitoring data in the EudraVigilance database, only signals related to an adverse reaction shall be considered [IR 520/2012 Art 19(1)].

For the purpose of Section 16.2 of the periodic benefit-risk evaluation report, signals relate to adverse effects (see GVP Annex IV, ICH-E2C(R2) Guideline).

See also Signal management process, Newly identified signal, Closed signal, Ongoing signal