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

Following unblinding due to a serious unexpected adverse drug reaction (SUADE), who must the sponsor inform?

1. The subject involved in the trial.

2. The manufacturer and/or regulatory authorities.

3. The principal investigator.

4. The ethics committee only.

The correct answer is: The manufacturer and/or regulatory authorities.

The correct option involves notifying the manufacturer and/or regulatory authorities after unblinding due to a serious unexpected adverse drug reaction (SUADE). This action is essential due to the critical nature of the information relating to patient safety and compliance with regulatory requirements. When a serious adverse event occurs that was unexpected and potentially serious, it is paramount for the sponsor to communicate this promptly to regulatory authorities. These authorities need to assess the situation to ensure public safety and may require additional information or modifications to the clinical trial based on the event's implications. Informing the manufacturer is also crucial, particularly if the adverse event is linked to a specific product. Manufacturers must be aware of serious adverse reactions to take necessary actions such as updating product safety information, conducting further investigations, or even conducting risk assessments related to their drug. While other parties, such as the principal investigator and the ethics committee, should eventually be informed to manage the trial properly and ensure ongoing oversight and patient safety, the immediate responsibility for reporting lies with the sponsor to regulatory officials and manufacturers to comply with ethical and legal obligations.