Definition

A structured report documenting a single patient's adverse event experience with a medicinal product, formatted according to ICH E2B standards for regulatory submission.

Example

When a patient experiences Stevens-Johnson syndrome after taking an antibiotic, all relevant information (patient demographics, event details, drug information, outcome) is compiled into an ICSR for submission.

Regulatory source

ICH E2B(R3)

Common mistakes

Including multiple unrelated patients in a single ICSR. Each ICSR should represent one patient's experience.

Inspector question

Show me how you ensure ICSR completeness before submission. What quality checks are in place?

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