Newly identified signal

In periodic benefit-risk evaluation reports, a signal first identified during the reporting interval, prompting further actions or evaluation (see GVP Annex IV, ICH-E2C(R2) Guideline).

This definition could also apply to a previously closed signal for which new information becomes available in the reporting interval prompting further action or evaluation (see GVP Annex IV, ICH-E2C(R2) Guideline).

This definition is also applicable to periodic safety update reports.

See also Signal, Closed signal