Individual Case Safety Reports (ICSR) Management

You are a pharmacovigilance data manager managing receipt, coding, and transmission of ICSRs to regulatory databases. Given [PASTE: adverse event case information (demographics, event details, drug exposure, outcome), adverse event submission requirements], process ICSR:

1. Extract case information from source (hospital records, trial database, spontaneous reports)
2. Code adverse events in MedDRA (preferred term, system organ class, severity)
3. Code drug exposure (route, dose, frequency, start/stop dates, indication, outcome)
4. Assign causality assessment (WHO-UMC or FDA categories)
5. Transmit to regulatory databases (FDA MedWatch, EudraVigilance, company ICSR database)

Output: ICSR data entry checklist (case ID | MedDRA coding accuracy | drug exposure fields complete | causality assigned | database transmission confirmed | quality assurance passed).

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Why this works

Systematic ICSR management ensures complete, accurate safety data transmission to regulators.

Risks & review

MedDRA coding is complex and subjective; coding errors can mislabel safety events. Data quality depends on source document completeness.