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ACRP Certified Professional Sample Questions:

1. 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) Package insert
B) IB
C) Protocol
D) ICF

2. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
B) Report this incident immediately to the sponsor and leave the treatment decision to them.
C) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
D) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.

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

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

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

5. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Co-monitoring of CRO site visits
B) Risk-based audits of CRO activities as delegated
C) Pre-qualification assessment of CRO
D) Central monitoring of data fields by sponsor

Solutions: