Intake & triage
Adverse event reports are logged, triaged for seriousness and expectedness, and routed for processing within regulatory timelines.
What's included
What goes into ICSR processing
- Adverse event reports logged, triaged for seriousness and expectedness, and routed for processing within regulatory timelines
- Quality-controlled data entry against source documents, with consistent MedDRA/WHODrug coding applied across the case series
- Case narratives structured to flow directly into signal detection and aggregate reporting without rework
- Cases tracked against the SAE Reconciliation Plan so safety and clinical data stay aligned throughout conduct
- A documented, audit-traceable record for every case from intake through closure
Downstream consistency
Processed cases feed directly into aggregate reporting, with medical coding applied consistently across the case series.