UNIT 7: Individual Case Safety Report (ICSR) – Fundamentals
This unit explains the concept, purpose, and regulatory importance of Individual Case Safety Reports (ICSRs), which form the backbone of Pharmacovigilance activities. It clearly describes what constitutes a valid ICSR, how cases are classified, and why accurate case reporting is critical for patient safety and regulatory decision-making.
Definition
An Individual Case Safety Report (ICSR) is a structured report containing information on one or more suspected adverse events experienced by an individual patient, associated with the use of a medicinal product.
ICSRs are the fundamental units of safety data in pharmacovigilance. Each report represents a single patient experience and serves as a primary source for safety monitoring, signal detection, and regulatory assessment. Even a single well-documented ICSR can lead to identification of new safety concerns.
Key Points
ICSRs are patient-specific safety reports.
They may include one or multiple adverse events.
They are used throughout the product lifecycle.
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