Solicited sources of individual case safety reports

Organised data collection systems, which include clinical trials, registries, post-authorisation namedpatients use programmes, other patient support and disease management programmes, surveys of patients or healthcare providers or information gathering on efficacy or patient compliance. For the purpose of safety reporting, solicited reports should not be considered spontaneous but classified as individual case safety reports from studies and therefore should have an appropriate causality assessment by a healthcare professional or the marketing authorisation holder (see GVP Annex IV, ICH-E2D).

See also Clinical trial, Post-authorisation safety study, Non-interventional study