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

2. 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) Identify critical processes and data during protocol development.
D) Determine the quality tolerance limits for data transcription errors.

3. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A) Comparing source document data to other data recorded in the same study time period.
B) Recording the date and time each data element is entered onto the source document.
C) Allowing real-time access for data review in the eCRF.
D) Recording data on source documents at the time the data are collected during the conduct of the study.

4. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) ICF
B) IB
C) Protocol
D) Package insert

5. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) Yes, the PI has a sufficient patient population to take part in this study.
B) Yes, the PI can perform other imaging scans instead of the PET scans.
C) No, the PI is taking part in too many ongoing studies to participate in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.

Solutions: