ACRP ACRP Certified Professional ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question #1
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. PI
B. CRA
C. IRB/IEC
D. CRC

Question #2
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, report the risk to the trial sponsor and await their decision.
B. Accept this site and plan to undertake routine safety evaluations of the IP.
C. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D. Accept this site and implement and maintain QA and QC systems with written SOPs.

Question #3
A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A. Notify the subject.
B. Notify the sponsor.
C. Withdraw the subject.
D. Notify the regulatory authority.

Question #4
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Meet with the site staff to understand their workflows and to review retention strategies.
B. Require participants to provide documented reason for withdrawal.
C. Interview participants who have dropped out.
D. Submit revised ICFs to the IRB/IEC with increased compensation for participants.

Question #5
In a quality management system, in which category do risk reduction activities belong?

A. Risk Evaluation
B. Risk Communication
C. Risk Control
D. Risk Review

Solutions: