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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A. Obtain IRB/IEC approval
B. Ship/receive IP
C. Schedule a site initiation visit
D. Verify subject eligibility

Question 2

During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
B. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
C. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
D. Immediately unblind the entire trial to ensure patient safety.

Question 3

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

Question 4

Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A. Register IP in IWRS and continue with subject allocation.
B. Dispose of IP and request replacement from sponsor.
C. Register IP in IWRS, quarantine and notify sponsor of the excursion.
D. Quarantine IP without registering in IWRS and request replacement from sponsor.

Question 5

Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A. Central monitoring of data fields by sponsor
B. Co-monitoring of CRO site visits
C. Risk-based audits of CRO activities as delegated
D. Pre-qualification assessment of CRO

Solutions: