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

Under what circumstance would unblinding typically occur?

1. At the beginning of a study

2. When a subject completes the study

3. When the investigator wants to avoid randomization to placebo during a Serious Adverse Event

4. When a subject withdraws from the study

The correct answer is: When the investigator wants to avoid randomization to placebo during a Serious Adverse Event

Unblinding typically occurs in clinical trials to ensure the safety and well-being of study participants. In the circumstance where a subject experiences a Serious Adverse Event (SAE), the investigator may decide that it is critical to unblind the study. This is done to retrieve important information about the treatment the subject is receiving, allowing for appropriate medical intervention and care. The need to avoid randomization to a placebo during a serious medical situation underscores the priority of patient safety and adherence to ethical standards in clinical research. In this context, if an adverse event is severe enough to warrant immediate action, knowing whether the subject is receiving the active treatment or the placebo is vital for determining the best course of action. This scenario highlights the balance between maintaining the integrity of a trial and prioritizing participant safety.