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

When should an investigator unblind a subject experiencing a serious unexpected adverse drug reaction in a blinded trial?

1. After the trial is completed.

2. Before reporting the SUADE to determine a safe treatment.

3. Immediately after the event is documented.

4. Unblinding is not necessary.

The correct answer is: Before reporting the SUADE to determine a safe treatment.

The appropriate time for an investigator to unblind a subject experiencing a serious unexpected adverse drug reaction (SUADE) in a blinded trial is before reporting the SUADE to determine a safe treatment. This is important for several reasons. First, in the event of a serious adverse reaction, the investigator needs to ensure the safety and well-being of the participant. Unblinding allows the investigator to identify which treatment the subject received, thus enabling an assessment of whether the reaction is linked to the treatment or is part of the participant’s natural history of the condition being studied. Secondly, this action is crucial for making informed decisions about the participant's continued involvement in the trial. If necessary, the investigator can provide the appropriate medical care or withdraw the subject from the study to prevent further harm. Moreover, unblinding prior to reporting the serious adverse reaction is essential for compliance with regulatory requirements and ethical responsibilities. It ensures that reporting and regulatory bodies have accurate information regarding the nature and severity of the adverse event in relation to the treatment being administered. Options suggesting that unblinding should occur after the trial is completed, immediately after the event is documented, or that unblinding is not necessary overlook the critical prioritization of participant safety and the need for timely