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ACRP ACRP-CP Exam Syllabus Topics:

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) Yes, the PI has a sufficient patient population to take part 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) No, the PI is taking part in too many ongoing studies to participate in this study.

2. The PI should ensure that source data is:

A) Accurately reflected in the eCRFs.
B) On worksheets that are provided by the sponsor.
C) Printed directly from the EMR.
D) Kept on site for a minimum of 2 years.

3. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Sponsor
B) IRB/IEC
C) CRO
D) Investigator

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

5. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Clinical Monitoring Plan
B) Data & Safety Monitoring Plan
C) Standard Operating Procedure
D) Investigator's Brochure

Solutions: