ACRP ACRP Certified Professional ACRP-CP

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ACRP Certified Professional Sample Questions:

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

2. After the completion or termination of a clinical trial, who should store the enrollment log?

A) Regulatory authority
B) CRO
C) Sponsor
D) PI

3. 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) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
C) Continue reporting temperature excursions per the pharmacy manual guidelines.
D) Install an air cooler requiring regular water refills to maintain the room temperature.

4. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
B) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
C) They can attend the meeting and can vote/provide opinion on whether to approve the study.
D) They cannot be the PI on the clinical study due to conflict of interest.

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

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

Solutions: