Chapter 8: Individual Case Safety Reports (ICSR) Management in Pharmacovigilance
Synopsis
Author
Miss Hyndavi Trylockya Nagumantri,
PharmD Scholar, Department of Pharmacy Practice, Koringa College of Pharmacy, Korangi, Kakinada, Andhra Pradesh, India
Abstract
The operational engine of a pharmacovigilance department is the processing of Individual Case Safety Reports (ICSRs), a highly structured, assembly-line workflow required to transform raw safety information into a valid regulatory submission. The lifecycle begins with Book-in and Triage, critical steps that establish the "Day 0" regulatory clock and prioritize cases based on seriousness and reporting timelines. The core processing phase involves Data Entry, where clinical details are transcribed into structured database fields, and Narrative Writing, where the medical story is synthesized into a coherent chronological summary. To ensure accuracy and consistency, every case undergoes a rigorous Quality Review (QR) before medical assessment. Beyond the initial processing, active Follow-up procedures are essential. Safety teams must exercise due diligence to query reporters for missing information, transforming incomplete reports into medically assessable cases. This entire process is governed by strict compliance standards, ensuring that every valid adverse event is captured, assessed, and reported to health authorities like the FDA and EMA within the legally mandated 7-day or 15-day windows, preventing regulatory non-compliance and ensuring continuous safety monitoring
Keywords: Individual Case Safety Reports (ICSRs), Case Triage, Safety Narratives, Expedited Reporting, Follow-up Procedures
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