Definition

A serious adverse reaction from a clinical trial that is both suspected to be caused by the investigational product and is not consistent with the Investigator's Brochure.

Example

In a clinical trial, a patient develops Stevens-Johnson syndrome not listed in the IB. This SUSAR requires expedited reporting to regulators and notification to investigators/IRBs.

Regulatory source

ICH E2A, EU CT Regulation

Common mistakes

Reporting all SAEs as SUSARs without proper expectedness assessment against the IB, or missing true SUSARs due to inadequate IB review.

Inspector question

How do you determine expectedness for clinical trial events? Show me your IB and demonstrate the assessment process.

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