In seeking evidence of adverse drug effects and adverse drug reactions, those working in pharmacovigilance recognise the phenomenon of a signal that raises the suspicion of a causal relation between a drug and an adverse effect or reaction. Manfred Hauben and I, based on etymology, usage, previous definitions, and the processes involved, have defined a signal of suspected causality as follows:
signal of suspected causalityn. information that arises 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, which would command regulatory, societal, or clinical attention, and is judged to be of sufficient likelihood to justify verificatory and, when necessary, remedial actions
This definition, with small variations, was republished by the Council for International Organizations of Medical Sciences (CIOMS) in 2010 and was adopted by one of its working groups in 2020. We take this as a signal of approval of the definition.