Individual Case Safety Reports (ICSR) Management Prompt

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).