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

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In a diabetes research study, if a subject develops colon cancer deemed unrelated to the study, is this considered a serious adverse event?

  1. True

  2. False

  3. Only if symptomatic

  4. Only if life-threatening

The correct answer is: False

A serious adverse event (SAE) is defined as an event that results in death, is life-threatening, requires hospitalization, results in a prolonged hospital stay, or causes significant disability or incapacity. In this context, if a study subject develops colon cancer and it is determined to be unrelated to the study, it does not meet the criteria for an SAE. The key factor here is the "unrelated" aspect; since the colon cancer is not connected to the intervention or procedures being tested in the diabetes research study, it does not classify as a serious adverse event in relation to the study. Serious adverse events typically need to be directly tied to the treatment or intervention being tested in a study. Therefore, the correct answer reflects this understanding of what constitutes a serious adverse event in clinical research.

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