Case Processing & Narrative Writing: End-to-End Discipline for Inspection-Ready Pharmacovigilance
Case Processing & Narrative Writing: End-to-End Discipline for Inspection-Ready Pharmacovigilance From Case Intake to Narrative: Building Pharmacovigilance Files that Regulators Trust Blueprint of an ICSR: Intake, Validation, and Workflow You Can Defend Individual Case Safety Reports (ICSRs) are the atomic units of pharmacovigilance. A defensible case-processing system turns disparate safety information—site SAE forms, spontaneous reports,…