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ACRP Certified Professional Sample Questions:

1. 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) No, the PI does not have the resources to perform all protocol-required procedures.
C) Yes, the PI can perform other imaging scans instead of the PET scans.
D) Yes, the PI has a sufficient patient population to take part in this study.

2. In a quality management system, in which category do risk reduction activities belong?

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

3. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Principal Investigator
B) Study pharmacovigilance physician
C) Medical monitor
D) Subject's primary care physician

4. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The CRC should write a note to file.
B) The PI should notify the monitor.
C) The PI should amend the medical chart.
D) The CRC should amend the medical chart.

5. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A) Sponsor
B) DSMB/IDMC
C) PI
D) IRB/IEC

Solutions: