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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A. Documenting all possible risk scenarios.
B. Assessing risk based on study impact.
C. Identifying potential study risks.
D. Controlling risk by setting thresholds of risk acceptability.

Question 2

A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A. IDMC/DSMB Report
B. Investigator Brochure
C. Clinical Study Protocol
D. Clinical Study Report

Question 3

The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A. Inform the monitor of the termination of the study.
B. Schedule participant for early termination visit.
C. Inform participant and assure proper care is provided.
D. Inform the IRB/IEC of the study closure.

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

Question 5

A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

A. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
B. Install an air cooler requiring regular water refills to maintain the room temperature.
C. Continue reporting temperature excursions per the pharmacy manual guidelines.
D. Return all IP and request the CRO/Sponsor to directly ship IP to participants.

Solutions: