Spontaneous report, synonym: Spontaneous notification

An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme (see GVP Annex IV, ICH-E2D).

In this context, an adverse reaction refers to a suspected adverse reaction.

Stimulated reporting can occur in certain situations, such as after a direct healthcare professional communication (DHPC), a publication in the press or questioning of healthcare professionals by company representatives, and adverse reaction reports arising from these situations are considered spontaneous reports (see GVP Annex IV, ICHE2D), provided the report meets the definition above. Reporting can also be stimulated by invitation from patients’ or consumers’ organisations to their members, or a class lawsuit. Reporting made in the context of early postmarketing phase vigilance (EPPV), e.g. in Japan, is also considered stimulated reporting.