Signal validation

Process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal [IR 520/2012 Art 21(1)].

This evaluation should take into account the strength of the evidence, the clinical relevance and the previous awareness of the association.

See also Signal detection, Validated signal, Non-validated signal