Definition

An adverse event report received from a patient, family member, or other non-healthcare professional individual who has direct experience with the product.

Example

A patient's daughter calls to report that her father developed confusion after starting a new medication. Though not medically trained, she provides valuable first-hand observations.

Regulatory source

ICH E2D, FDA MedWatch

Common mistakes

Undervaluing consumer reports because they lack medical terminology. Consumers often provide unique insights about real-world product use.

Inspector question

How do you follow up on consumer reports when medical confirmation is needed but the consumer cannot provide HCP contact information?

Related terms