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

What is the classification for a serious adverse drug reaction when a subject's legs swell after a cardiac drug study?

1. Minor Adverse Drug Reaction

2. Serious Adverse Drug Reaction

3. Severe Adverse Drug Reaction

4. Mild Adverse Drug Reaction

The correct answer is: Serious Adverse Drug Reaction

A serious adverse drug reaction is classified as a harmful and unintended response to a drug that can result in significant health implications for the patient. When a subject's legs swell after participating in a cardiac drug study, this reaction indicates a more severe and potentially critical response to the medication administered. Swelling, or edema, particularly in the legs, could signify a variety of underlying issues, such as cardiovascular, kidney, or circulatory problems, especially in the context of a drug intended for cardiac conditions. The seriousness of this reaction is heightened by the potential need for medical intervention or the risk of long-term health consequences. Differentiating this from the other classifications, a serious adverse drug reaction is not simply minor, severe, or mild; rather, it encompasses the seriousness and the potential for medical attention that goes beyond those categorizations. Therefore, the classification is appropriately labeled as serious.