Definition

A patient in an adverse event report who can be identified by at least one qualifier such as initials, date of birth, age, age group, gender, or patient identification number.

Example

A patient can be identified as '65-year-old female' even without a name. However, 'a patient' without any qualifying information is not identifiable.

Regulatory source

ICH E2D Section 3.1.1

Common mistakes

Rejecting cases where only age group (e.g., 'elderly') is provided. Age group alone can qualify as identifiable patient.

Inspector question

If a reporter provides only 'adult male' as patient information, do you consider this identifiable? What is your rationale?

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