Closed signal

In periodic benefit-risk evaluation reports, a signal for which an evaluation was completed during the reporting interval (see GVP Annex IV, ICH-E2C(R2) Guideline).

A safety signal can be closed either because it is refuted or because it is determined to be a potential or identified risk following evaluation (see GVP Annex IV, ICH-E2C(R2) Guideline).

This definition is also applicable to periodic safety update reports.

See also Signal, Refuted signal