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

What does the acronym SAE stand for in clinical research?

1. Serious Adverse Event

2. Severe Adverse Effect

3. Standard Adverse Event

4. Simple Adverse Effect

The correct answer is: Serious Adverse Event

In clinical research, the acronym SAE specifically stands for Serious Adverse Event. This term is crucial as it refers to any untoward medical occurrence that can result in notable health consequences, such as death, a life-threatening situation, hospitalization, or significant disability. Understanding this terminology is important for researchers and healthcare professionals because it guides reporting requirements and safety monitoring protocols in clinical trials. The identification and tracking of SAEs are fundamental to maintaining participant safety and ensuring the integrity of the research. This definition and understanding of SAEs also help distinguish them from less severe adverse effects, ensuring that serious issues are prioritized and addressed appropriately in the study context.