Signal Detection

Signal detection is the systematic process of identifying signals of potential safety concerns from pharmacovigilance data. A signal is information suggesting a new potentially causal association, or a new aspect of a known association, between an intervention and an adverse event.

Methods include disproportionality analysis (comparing observed vs. expected reporting rates), clinical review of case series, literature surveillance, and data mining of spontaneous reporting databases. Signals require validation, prioritization, and investigation.

Signal management includes detection, validation, prioritization, assessment, and action. EU GVP Module IX provides detailed guidance on signal detection and management.