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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

2. Which of the following reports should be retained in participant charts?

A) Lab reports
B) Safety reports
C) DSMB/IDMC reports
D) IRB/IEC progress reports

3. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Consult with the IRB/IEC first.
B) Redact subject identification for privacy protection.
C) Allow access to the entire records.
D) Deny the request until the sponsor approves.

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

5. 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.

Solutions: