spontaneous report
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- 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.
- Used For
- spontaneous notification
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