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ACRP Certified Professional Sample Questions:

1. 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, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, single-blind, placebo-controlled 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

2. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) Yes, the PI can perform other imaging scans instead of the PET scans.
B) No, the PI is taking part in too many ongoing studies to participate in this study.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.

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

4. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) PRO.
B) CRF.
C) Worksheet.
D) Source document.

5. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This needs to be reported to the patient's primary care physician.
B) This qualifies for prompt reporting to the IRB/IEC within 15 business days.
C) This qualifies for expedited reporting to the sponsor.
D) This needs to be reported to the regulatory authorities within 10 business days.

Solutions: