A validated signal which, following further assessment has been determined to be “false”, i.e. a causal association cannot be established at that point in time.

It is noted that for the purpose of the periodic benefit-risk evaluation report (PBRER) ICH describes refuted signals as signals that, following evaluation, have been refuted as “false” signals based on medical judgment and a scientific evaluation of the currently available information (GVP Annex IV, ICH-E2C(R2) Guideline).

See also Validated signal, Signal assessment