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

Which of the following statements is TRUE regarding serious adverse events (SAEs)?

1. All SAEs require immediate reporting

2. Only life-threatening events classify as SAEs

3. Any adverse event can be classified as an SAE

4. SAEs must always result in hospitalization

The correct answer is: Only life-threatening events classify as SAEs

The statement that only life-threatening events classify as serious adverse events (SAEs) is generally misunderstood. In reality, a serious adverse event is defined not just by its life-threatening nature but rather by the impact it has on the participant’s health and safety. SAEs encompass a range of situations, including but not limited to death, life-threatening conditions, hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect. This means that while life-threatening events do fall under the category of SAEs, they are not the sole qualifying factor. For instance, an adverse event that results in significant disability or requires a major intervention can be classified as an SAE, even if it is not life-threatening. Therefore, the correct understanding of SAEs includes a broader category that does not limit serious adverse events only to those that are life-threatening. This distinction is critical for clinical research professionals in effectively monitoring and reporting SAEs to ensure participant safety and compliance with regulatory requirements.