SOCRA CCRP Practice Exam

What is the definition of a serious adverse event (SAE)?

1. An event that requires a simple medical treatment

2. Any untoward occurrence that results in death, life-threatening situation, requires hospitalization or prolongation of hospitalization, results in significant disability, or a congenital abnormality/birth defect

3. A minor side effect that does not require hospitalization

4. An adverse event that can be treated with over-the-counter medication

The correct answer is: Any untoward occurrence that results in death, life-threatening situation, requires hospitalization or prolongation of hospitalization, results in significant disability, or a congenital abnormality/birth defect

A serious adverse event (SAE) is an untoward occurrence that can have significant consequences, such as death, a life-threatening situation, hospitalization or prolonged stay in a hospital, or a significant disability. This means that options A, C and D are incorrect because they do not meet the criteria of a serious adverse event. Option A only requires simple medical treatment, while option C only refers to minor side effects that do not require hospitalization. Option D also only mentions treatment with over-the-counter medication, which would not fall under the definition of a serious adverse event. Therefore, the correct definition of an SAE is option B.