UNIT 8: ICSR Lifecycle and Case Processing
This unit explains the complete lifecycle of an Individual Case Safety Report from initial receipt to final submission and follow-up, reflecting how cases are actually handled in operational pharmacovigilance teams. It focuses on practical decision-making, regulatory timelines, data quality, and compliance-driven processing steps.
The ICSR lifecycle describes the sequence of activities performed from the moment a safety report is received until it is closed or updated with follow-up information. Each step in the lifecycle is regulated, time-bound, and quality-controlled to ensure patient safety and regulatory compliance.
Process Flow
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