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

Which of the following is NOT considered a Serious Adverse Event (SAE)?

1. Results in death

2. Requires inpatient admission

3. Temporary illness

4. Prolonged hospitalization

The correct answer is: Temporary illness

A Serious Adverse Event (SAE) is defined as an undesirable experience associated with the use of a medical product that results in significant consequences, which typically include death, necessitating hospitalization, or leading to a prolonged inability to perform normal daily activities. In this context, temporary illness does not meet the criteria set for seriousness because it implies a reversible condition that does not lead to any of the severe consequences outlined above. The other options—resulting in death, requiring inpatient admission, and prolonged hospitalization—reflect serious outcomes that carry substantial implications for patient safety and treatment. Temporary illness, in contrast, suggests a mild or short-lived condition, hence it is classified outside the scope of an SAE. Understanding these distinctions is crucial for anyone involved in clinical trials or patient safety monitoring, as it affects reporting responsibilities and the overall assessment of drug safety.