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ACRP Certified Professional Sample Questions:

1. 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.

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) No, the PI is taking part in too many ongoing studies to participate in this study.
B) Yes, the PI can perform other imaging scans instead of the PET scans.
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. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Routine monitoring
B) Inspection
C) Audit
D) Site qualification

4. Which of the following should be considered when implementing a risk-based monitoring plan?

A) 100% source document review is mandatory.
B) On-site monitoring frequency may change depending on the quality of the data.
C) Monitoring schedule must be pre-defined in the monitoring plan.
D) Centralized monitoring must be incorporated in any trials.

5. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A) The site may proceed with the destruction of the essential documents.
B) The site should retain the essential documents longer to meet the regulatory requirements.
C) The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
D) The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.

Solutions: