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

What is a criterion for including serious unexpected adverse drug reactions in clinical trial reporting?

1. The event must have been previously documented.

2. The investigator must determine if it’s safer to unblind the subject first.

3. All reactions must be reported to the public immediately.

4. Only severe reactions within the same treatment group need to be reported.

The correct answer is: The investigator must determine if it’s safer to unblind the subject first.

The reason the criterion regarding the investigator's determination on whether it is safer to unblind the subject first is correct relates to the responsibility of the investigator to ensure the safety and well-being of the trial participants. In cases of serious unexpected adverse drug reactions (SUSARs), the investigator must evaluate the severity and nature of the event to decide on the most ethical course of action, including whether the subject needs to be unblinded to receive appropriate care. This step is crucial since knowing the treatment a subject received could influence the clinical management of the adverse reaction. This criterion underscores the importance of patient safety as it ensures that the necessary follow-up care can be administered effectively and promptly. It emphasizes the ethical obligation to protect the participant while also gathering necessary information about the drug's safety profile during the clinical trial. In contrast, the other options do not align with the established criteria involving adverse event reporting. Previous documentation of an event does not directly relate to the protocols for serious unexpected reactions, immediate public reporting is not typically mandated for all reactions, and it's not sufficient to restrict reporting only to severe reactions within the same treatment group since it is critical to assess and report reactions comprehensively across all groups for the drug's overall safety profile.