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ACRP Certified Professional Sample Questions:

1. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B) A monitoring report that identifies deviation from the approved protocol.
C) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

2. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Blinding
B) Placebo-controlled
C) Randomization
D) Privacy controls

3. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Accept this site and implement and maintain QA and QC systems with written SOPs.
B) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
C) Accept this site and plan to undertake routine safety evaluations of the IP.
D) Before accepting this site, report the risk to the trial sponsor and await their decision.

4. 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) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

5. When designing a clinical trial, why is it important to define the study population?

A) To determine where to conduct the study
B) To support the study objectives
C) To support subject recruitment to the study
D) To determine the study objectives

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