Which statement best describes SUSAR?

Which statement best describes SUSAR?

• A. A serious adverse event not related to the investigational product.
• B. A serious adverse reaction suspected to be related to the investigational product and is expected.
• C. A serious adverse reaction suspected to be related to the investigational product and is unexpected.
• D. A non-serious adverse event.

Answer: (C)

SUSAR stands for Suspected Unexpected Serious Adverse Reaction. It means an adverse reaction that is serious, is suspected to be related to the investigational product, and is unexpected relative to what is already known about the product (not described in the current product information or investigator brochure). The statement fits best because it includes all three elements: seriousness, a suspected causal link to the investigational product, and unexpectedness. If any part is missing—if it’s not related to the product, if it’s expected, or if it’s not serious—it would not be a SUSAR. A serious adverse event that is not related to the product or an expected reaction related to the product, for example, would be handled differently and not classified as a SUSAR.

SUSAR stands for Suspected Unexpected Serious Adverse Reaction. It means an adverse reaction that is serious, is suspected to be related to the investigational product, and is unexpected relative to what is already known about the product (not described in the current product information or investigator brochure). The statement fits best because it includes all three elements: seriousness, a suspected causal link to the investigational product, and unexpectedness. If any part is missing—if it’s not related to the product, if it’s expected, or if it’s not serious—it would not be a SUSAR. A serious adverse event that is not related to the product or an expected reaction related to the product, for example, would be handled differently and not classified as a SUSAR.