TraceScribePharmacovigilance ICH E2A · E2B(R3)

Drug Safety ICSR + Signals

Recreation of a clinical-trial pharmacovigilance command center: ICSR case processing, MedDRA coding, the SUSAR expedited-reporting clock (ICH E2A: 7 days fatal/life-threatening, 15 days other), and signal detection by disproportionality (PRR / ROR). Synthetic safety database for a fictional investigational compound; MedDRA terms (SOC / PT) are the real vocabulary. Every figure is computed from the cases.