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ACRP Certified Professional Sample Questions:

1. The sponsor should supply a PI with the IP after:

A) Submission of documents to IRB/IEC and regulatory authority for review.
B) Approval of protocol by the PI.
C) Approval of protocol by the sponsor.
D) Approval/favorable opinion from IRB/IEC and regulatory authority.

2. 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) Install an air cooler requiring regular water refills to maintain the room temperature.
B) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
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.

3. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A) IRB/IEC.
B) Sponsor.
C) Regulatory authority.
D) Medical monitor.

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

5. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This qualifies for expedited reporting to the sponsor.
B) This needs to be reported to the regulatory authorities within 10 business days.
C) This needs to be reported to the patient's primary care physician.
D) This qualifies for prompt reporting to the IRB/IEC within 15 business days.

Solutions: