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

What qualifies as an Adverse Drug Reaction according to health care professionals or sponsors?

1. Any reaction reported

2. Those with a reasonable suspected causal relationship to the medicinal product

3. Only severe reactions

4. Reactions occurring after trial completion

The correct answer is: Those with a reasonable suspected causal relationship to the medicinal product

An Adverse Drug Reaction (ADR) is specifically defined as any unintended and harmful response to a medicinal product for which there is a reasonable suspected causal relationship. This definition emphasizes the importance of establishing a connection between the reaction and the drug in question. When health care professionals or sponsors assess ADRs, they look for evidence that supports the likelihood that the drug may have contributed to the negative outcome. This distinction is crucial because not every reaction reported constitutes an ADR. For instance, simply having a reaction does not indicate that it was caused by the drug; it must not only be reported but also have a plausible link to the drug for it to be classified as an adverse reaction. Thus, the phrasing of the correct answer highlights the necessity of suspecting a causal relationship, which reinforces the need for thorough investigation of each reported reaction. Reactions that are only severe or those occurring after the completion of a trial may not meet the criteria for classification as ADRs, as they do not necessarily account for the required causal relationship to the medicinal product. Similarly, categorizing any reported reaction as an ADR would dilute the significance of such classifications, making it important for health care professionals and sponsors to apply the appropriate criteria.