SUSAR differs from a general SAE because it is

SUSAR differs from a general SAE because it is

• A. Not related to IP
• B. Not serious
• C. Suspected to be related to IP and is unexpected
• D. Always fatal

Answer: (C)

SUSARs are defined by a combination of three ideas: the event is serious, it is suspected to be related to the investigational product, and it is unexpected based on what is already known about the product. This means the reaction is not only severe, but also potentially caused by the IP and not described in the current safety information (like the Investigator’s Brochure). If an event is clearly unrelated to the IP or is an already-described, anticipated reaction, it would not be a SUSAR—even if it’s serious. So the best description is that it’s suspected to be related to the IP and is unexpected.

SUSARs are defined by a combination of three ideas: the event is serious, it is suspected to be related to the investigational product, and it is unexpected based on what is already known about the product. This means the reaction is not only severe, but also potentially caused by the IP and not described in the current safety information (like the Investigator’s Brochure). If an event is clearly unrelated to the IP or is an already-described, anticipated reaction, it would not be a SUSAR—even if it’s serious. So the best description is that it’s suspected to be related to the IP and is unexpected.