Certified Clinical Research Associate (CCRA) Practice Exam

What are the three categories of severity for adverse events?

1. Mild, Moderate, Severe

2. Minor, Major, Critical

3. Light, Medium, Heavy

4. Negligible, Significant, Grave

The correct answer is: Mild, Moderate, Severe

The classification of adverse events into categories of severity is crucial in clinical research for understanding the impact of the event on a participant's health and the overall safety of the intervention. The correct categorization into mild, moderate, and severe allows researchers and regulatory bodies to communicate effectively about the nature of adverse events and to assess the risk-benefit balance of treatments. Mild events typically require minimal or no intervention and do not affect normal activity. Examples might include minor headaches or slight nausea that resolve on their own. Moderate events are more significant, possibly requiring intervention and causing some degree of discomfort or restriction in daily activities. Severe events, on the other hand, are those that pose a substantial risk to the patient or require intensive medical intervention, such as hospitalization, life-threatening conditions, or permanent damage. This classification differs significantly from other options presented. The terms in the other categories do not align with established medical terminology for assessing the impact of adverse events, making them less applicable in this context.