Stimulated Reporting

Stimulated Reporting refers to the act of healthcare professionals, patients, or consumers actively submitting adverse reaction reports in response to specific stimuli or events within the healthcare industry. These triggers can include direct communication from healthcare professionals, press publications, interactions with company representatives, or invitations from patient or consumer organizations to their members.

Such reports are categorized as spontaneous reports, as per the definition outlined in Annex IV, ICH-E2D. Stimulated Reporting is often associated with early-phase post-marketing vigilance (EPPV) activities, facilitating the timely collection of critical safety data and contributing to overall pharmacovigilance efforts.