Definition

A quantifiable measure used to evaluate the effectiveness and compliance of pharmacovigilance processes, such as timeliness, accuracy, and completeness rates.

Example

Key metrics include: percentage of expedited reports submitted on time (target: 100%), average processing time (target: <5 days), QC return rate (target: <5%).

Regulatory source

EU GVP Module I

Common mistakes

Tracking only submission timeliness without measuring data quality metrics like coding accuracy or narrative completeness.

Inspector question

What metrics do you track for pharmacovigilance performance? Show me trending data and how you address negative trends.

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