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

Which of the following must be reported as an adverse drug reaction?

1. Only those with severe outcomes

2. Reactions with reasonable causality to the medicinal product

3. All events occurring during the study

4. Incidental findings in subjects

The correct answer is: Reactions with reasonable causality to the medicinal product

The correct answer focuses on the importance of reporting reactions that have a reasonable connection to the medicinal product being studied. In clinical research and pharmacovigilance, an adverse drug reaction (ADR) is defined as any harmful or unintended response to a medicinal product that occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy. Reporting reactions with reasonable causality ensures that any significant safety concerns related to a product are captured and addressed. This thorough approach helps safeguard patient safety and contributes to the collective understanding of the drug's safety profile. In contrast, limiting reporting to severe outcomes would potentially overlook less severe but still significant reactions that could inform future use and safety assessments of the drug. Reporting all events occurring during the study could lead to overwhelming data that may not be directly related to the drug’s effects, making it difficult to identify relevant safety signals. Lastly, incidental findings in subjects may not necessarily relate to the medicinal product and are not usually classified as ADRs, hence they do not need to be reported in the context of evaluating medication safety. Thus, the emphasis on reactions with reasonable causality highlights a critical aspect of pharmacovigilance practices and regulatory expectations in clinical trials.