In Pharmacovigilance, every Individual Case Safety Report (ICSR) tells an important story. It reflects how a medicine interacts with a patient in real life. ICSRs help regulatory authorities and drug safety teams identify, analyze, and prevent adverse drug reactions , ensuring safer healthcare outcomes. Below is the complete life cycle of an ICSR , from the moment an adverse event is reported to its regulatory submission. 🧾 1. Case Intake / Receipt The ICSR process starts when a potential Adverse Event (AE) is reported. Reports may come from: Healthcare professionals Patients or caregivers Literature articles Clinical trials Regulatory agencies To consider the report valid , it must meet four essential criteria: Identifiable patient Identifiable reporter A suspect drug/procedure A reported adverse event 💻 2. Data Entry All information collected is entered into a Safety Database (e.g., Argus, ARISg, Veeva). This includes: Patient det...
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