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ACRP Certified Professional Sample Questions:

1. All of the following are examples of what monitors review EXCEPT:

A) Regulatory binder which includes copies of current certifications for all laboratories.
B) Potential patient medical records for eligibility prior to the informed consent process.
C) Documentation in the participant's medical record of study drug administration.
D) The signed ICF retained in the participant's study file.

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

3. 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 contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
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 retain the essential documents longer to meet the regulatory requirements.

4. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Identify critical processes and data during protocol development.
B) Perform a periodic review to see if the quality methods are effective and relevant.
C) Train the research coordinator on the required study assessments schedule.
D) Determine the quality tolerance limits for data transcription errors.

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

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

Solutions: