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A quantifiable measure used to evaluate the effectiveness and compliance of pharmacovigilance processes, such as timeliness, accuracy, and completeness rates.
Key metrics include: percentage of expedited reports submitted on time (target: 100%), average processing time (target: <5 days), QC return rate (target: <5%).
EU GVP Module I
Tracking only submission timeliness without measuring data quality metrics like coding accuracy or narrative completeness.
What metrics do you track for pharmacovigilance performance? Show me trending data and how you address negative trends.