Definition

The four essential data elements required to consider an adverse event report valid and processable: identifiable reporter, identifiable patient, suspect product, and adverse event/reaction.

Example

A report states 'someone took a pill and felt sick' - this lacks minimum information because neither the patient nor reporter is identifiable. Compare to 'Dr. Smith reports that his patient John had nausea after taking Aspirin' - this has all four elements.

Regulatory source

ICH E2D Section 3.1

Common mistakes

Confusing minimum information with minimum required data fields in the E2B form. Minimum information relates to validity, not data completeness.

Inspector question

Walk me through how you handle a report that has three of four minimum elements. What attempts do you make to obtain the missing element?

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