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ACRP Certified Professional Sample Questions:

1. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
B) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C) Update the IB to add the risk of infection and submit to the sponsor for approval.
D) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

2. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Worksheet.
B) Source document.
C) PRO.
D) CRF.

3. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Health authority
C) Investigator
D) Sponsor

4. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) A monitoring report that identifies deviation from the approved protocol.

5. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Call the participant to return for an unscheduled visit.
B) Report a protocol deviation to the IRB/IEC.
C) Notify the sponsor.
D) Notify the PI.

Solutions: