Definition

A structured process to obtain specific additional information for certain types of adverse events to enable thorough medical assessment.

Example

For any reported case of anaphylaxis, targeted follow-up questions include: exact time of onset, all treatments administered, allergy history, confirmation of diagnosis, and outcome details.

Regulatory source

Company SOPs, Risk Management Plans

Common mistakes

Using generic follow-up for all cases rather than event-specific questions that capture medically relevant details.

Inspector question

Do you have targeted follow-up questionnaires? Show me how they're used and how completion rates are tracked.

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