最新のACRP-CP問題集で試験を準備する

A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

• A. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
• B. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
• C. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
• D. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population

An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

• A. Update the IB to add the risk of infection and submit to the sponsor for approval.
• B. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
• C. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
• D. Add the risk of infection to the ICF and submit to the IRB/IEC for review.

A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

• A. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
• B. Report this incident immediately to the sponsor and leave the treatment decision to them.
• C. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
• D. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.

Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

• A. Monitor
• B. Coordinator
• C. Investigator
• D. Sponsor

A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

• A. To determine if a protocol amendment is needed
• B. To escalate corrective actions to the regulatory authority
• C. To establish a procedure for PI oversight of protocol deviations
• D. To determine if the deviations invalidate the data