Definition

An unsolicited adverse event report that comes from sources outside organized data collection systems, typically from healthcare professionals or patients who voluntarily report their experience.

Example

A pharmacist notices a pattern of patients complaining about dizziness after starting a new medication and calls the manufacturer to report this observation. This is spontaneous because it wasn't requested.

Regulatory source

ICH E2D Section 2.1

Common mistakes

Classifying reports from patient support programs as spontaneous. If the company actively collects information, reports may be solicited.

Inspector question

How do you distinguish between spontaneous and solicited reports in your patient support programs?

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