SOCRA CCRP Practice Exam

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What is the difference in AE reporting between drug and device trials?

  1. Device trials require more rigorous AE reporting

  2. Drug trials do not need to record all AEs

  3. Drug trials record and evaluate all AEs for drug relationship, device trials might not

  4. There is no difference in AE reporting

The correct answer is: Drug trials record and evaluate all AEs for drug relationship, device trials might not

Drug and device trials have different reporting guidelines for adverse events (AEs). In drug trials, all AEs are recorded and evaluated for their relationship to the drug being tested. In device trials, all AEs may not be evaluated for their relationship to the device being tested. Therefore, option C is correct. Options A, B, and D are all incorrect because they either make generalizations about the reporting requirements for drug and device trials or imply that there is no difference in AE reporting between the two types of trials, which is not true.

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