Serious health threat

A serious health threat triggers urgent action, such as stopping enrolment or warning sites, and fast reporting to authorities and ethics committees.

signal from any adverse event or device deficiency (3.19) that indicates an imminent risk of death or a serious deterioration in the health in subjects (3.50), users or other persons, and that requires prompt remedial action for other subjects, users, or other persons Note 1 to entry: This would include events that are of significant and unexpected nature such that they become alarming as a potential serious health hazard or possibility of multiple deaths occurring at short intervals.

ISO 14155:2020, clause 3.46