An Individual Case Safety Report (ICSR) is a structured report that captures details of a single adverse event or suspected adverse reaction associated with a medicinal product.
ICSRs include patient information (as permitted), event description, seriousness, outcomes, relevant medical history, and the reporterís causality assessment. In clinical trials, ICSRs are used for expedited safety reporting and ongoing pharmacovigilance, including sponsor submissions to regulators. High-quality ICSRs improve signal detection by enabling consistent review and aggregation across cases. Timely and accurate ICSR processing is essential for protecting participants and meeting safety reporting obligations.