Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Are all Serious Adverse Events (SAEs) required to be life-threatening to qualify as an SAE?

1. Yes

2. No

3. Only in specific studies

4. Only if specified in the protocol

The correct answer is: No

To qualify as a Serious Adverse Event (SAE), an event does not necessarily need to be life-threatening. The crucial criteria for an event to be classified as an SAE include whether the event results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The emphasis here is on the broader definition of SAEs, which encompasses a variety of severe medical events beyond life-threatening occurrences. For instance, an event such as a significant reaction that requires hospitalization without being life-threatening still qualifies as an SAE. This understanding underscores the importance of careful monitoring and reporting of all SAEs during clinical trials, ensuring that researchers are alert to various significant medical issues that could arise, irrespective of their direct life-threatening nature. Thus, while life-threatening events are certainly included in the definition of SAEs, it is not a blanket requirement for something to be categorized as such.