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

In clinical trials, which event is typically not classified as an adverse drug reaction?

1. Fatal events related to the study drug

2. Expected side effects of the treatment

3. Serious unexpected reactions

4. Life-threatening events linked to the drug

The correct answer is: Expected side effects of the treatment

In clinical trials, expected side effects of the treatment are typically not classified as adverse drug reactions because they are anticipated based on prior knowledge of the drug's pharmacological profile and clinical data collected from earlier studies or trials. When a drug is developed, researchers and clinicians often have information on its potential effects and side effects, which helps in predicting what might occur during treatment. These expected side effects are taken into consideration during the planning of the trial and are usually outlined in the study protocol and informed consent documents. In contrast, fatal events, serious unexpected reactions, and life-threatening events that arise during the trial would generally be classified as adverse drug reactions. These events indicate responses that are either severe, unexpected, or directly linked to the use of the drug and may pose a risk to the subjects involved in the trial. The classification of expected side effects allows researchers to distinguish between risks already known and those that are new or unanticipated, enabling better risk management and safety assessments during the clinical trial process.