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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A. Inform participant and assure proper care is provided.
B. Schedule participant for early termination visit.
C. Inform the monitor of the termination of the study.
D. Inform the IRB/IEC of the study closure.

Question 2

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

Question 3

A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A. The site receives approval from the medical monitor to begin enrolling.
B. The DSMB meets and the first DSMB meeting report has been issued.
C. The CRA has performed source document review and verification at the site.
D. A signed clinical trial agreement between the site and sponsor is in place.

Question 4

Which statement does NOT represent a study monitor's responsibilities?

A. Report serious adverse events to the IRB/IEC.
B. Check the accuracy and completeness of case report forms with source documents.
C. Provide communication between the sponsor and the PI.
D. Verify that the PI has adequate qualifications and resources to conduct the study.

Question 5

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. Privacy controls
C. Randomization
D. Placebo-controlled

Solutions: