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

What are expected adverse events (AEs) in clinical trials?

1. Unpredictable and severe side effects

2. Events inconsistent with patient histories

3. Events consistent with prior trials

4. Minor and temporary side effects

The correct answer is: Events consistent with prior trials

Expected adverse events (AEs) in clinical trials refer to occurrences that are consistent with prior knowledge of the drug or treatment being studied. These include side effects that have been documented in earlier studies or known from the drug's mechanism of action. As such, when researchers design a clinical trial, they rely on existing data from previous trials to anticipate what adverse events might occur in participants. By understanding that certain adverse events are likely based on past findings, researchers can better monitor participant safety and manage those events when they arise. This proactive approach ensures that the trial can be conducted ethically and safely while gathering valuable data on the treatment’s effects. While some adverse events may indeed be severe or minor, not all are classified as expected AEs. Side effects that are unpredictable or have not been previously observed would be identified as unexpected, and those inconsistent with patient histories fall outside the typical parameter of 'expected.' Thus, events that align with prior trials are fundamental in ensuring the integrity of the study and the protection of its participants.