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

Which criterion must be met to classify an Adverse Event as an Adverse Drug Reaction according to ICH-GCP?

1. That it presents few side effects

2. That a causal relationship is at least a reasonable possibility

3. That it occurs in more than one subject

4. That the subject reports it to a healthcare provider

The correct answer is: That a causal relationship is at least a reasonable possibility

To classify an Adverse Event (AE) as an Adverse Drug Reaction (ADR) according to the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, the essential criterion that must be met is that there is at least a reasonable possibility that a causal relationship exists between the drug and the adverse event. This means that the event must be linked to the administration of the drug in a way that suggests that the drug could be a contributing factor to the occurrence of the adverse event. Understanding the nuances of this criterion is crucial for recognizing the significance of drug safety in clinical research. While other options may present various scenarios involving adverse events, they do not align with the specific definition established by regulatory guidelines. For instance, an adverse event could occur in a single subject and still be classified as an ADR if the causal relationship is established, which underscores the emphasis on causation rather than prevalence or reporting alone.