Definition

Formal inpatient admission to a hospital for treatment or observation, which qualifies an adverse event as serious. Emergency room visits alone typically do not qualify unless followed by admission.

Example

A patient admitted overnight for observation after a syncopal episode meets the hospitalization criterion for seriousness, even if discharged the next day with no sequelae.

Regulatory source

ICH E2A, FDA Guidance

Common mistakes

Counting ER visits without admission as hospitalization, or counting elective surgeries unrelated to an adverse event.

Inspector question

How do you handle cases where a patient visits the ER but is not formally admitted? What about same-day surgery facilities?

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