Definition

A substantial disruption of the patient's ability to conduct normal life functions resulting from an adverse event, qualifying it as serious.

Example

A patient develops permanent hearing loss after taking an ototoxic antibiotic. This persistent disability meets the seriousness criterion regardless of whether hospitalization occurred.

Regulatory source

ICH E2A

Common mistakes

Including temporary symptoms as disability. The criterion requires persistent or significant disruption to normal life functions.

Inspector question

How do you assess whether an impairment rises to the level of 'significant disability'? What documentation do you require?

Related terms