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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A. Investigators participating in the trial.
B. Independent qualified individuals.
C. Regulatory authority expert advisors.
D. Executive board members.

Question 2

A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A. Reject the null hypothesis that the drug has no effect on cholesterol levels.
B. Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
C. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
D. Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.

Question 3

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

Question 4

The IB contains which of the following sections?

A. Participant eligibility criteria
B. Known pharmacokinetic effects
C. Participant dosing schedule
D. IP preparation instructions

Question 5

A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A. Any trial-related duties can be documented as transferred by verbal agreement.
B. All duties transferred to a CRO should be specified in writing.
C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
D. The IRB/IEC must approve the transfer of duties to a CRO.

Solutions: