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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Which of the following statements is TRUE about an EDC system?

A) IRB/IEC approval is required before the use of the computerized system.
B) There should be an audit trail to track data entries, deletions, and changes.
C) The eCRF should be an exact page-by-page replica of the paper CRF.
D) A separate workstation should be made available for the monitor.

2. The investigator/institution should permit:

A) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
B) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
C) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
D) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

3. When assessing the monitoring needs for a study, sponsors should:

A) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
B) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
C) Permit PIs to select a monitor for their site as long as they are independent of the PI.
D) Use central monitoring instead of conducting physical monitoring visits at sites.

4. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Privacy controls
B) Blinding
C) Placebo-controlled
D) Randomization

5. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How effective is the drug at treating patients that have been previously diagnosed with cancer?
B) How likely are patients at high risk of cancer going to develop cancer during the study?
C) How does the risk of developing cancer compare to the anticipated side effects from the drug?
D) How willing are current patients to participate in a trial with potentially serious side effects?

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