Regulatory Affairs Certification (RAC) Practice Exam

During a periodic visit to a clinical investigator, the study monitor should assure all of the following EXCEPT:

1. Informed consent has been documented in subjects.

2. The study protocol is being followed.

3. The investigator has assigned activities in the protocol to other staff.

4. Changes to the protocol have been approved.

The correct answer is: The investigator has assigned activities in the protocol to other staff.

The focus during a periodic visit by a study monitor is to ensure compliance with the study protocol, ethical guidelines, and regulatory requirements. This includes verifying that informed consent is documented properly for each subject participating in the study, ensuring that the study protocol is being followed without deviations, and confirming that any changes to the protocol have been duly approved by the relevant authorities or ethics committees. Assigning activities outlined in the protocol to other staff members is generally within the investigator's purview, provided that they adhere to the protocol requirements and responsibilities assigned to them. However, this is not a primary focus of the monitoring visit. The monitor's main concern is to ensure that regulatory compliance, protocol adherence, informed consent, and proper documentation are in place. The delegation of tasks to other personnel is a management decision of the investigator, and while it should be appropriately documented, it is not usually assessed as part of the monitor's primary responsibilities during a visit, making this choice less critical to the monitoring process compared to the other options.