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ACRP Certified Professional Sample Questions:

1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Approved by the IRB/IEC.
B) Licensed to practice medicine.
C) An employee of the institution.
D) Under the supervision of the PI.

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) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
D) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.

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

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

4. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
B) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
C) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
D) The CRC is responsible for identifying the relationship of an SAE to the IP.

5. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
B) Accept this site and implement and maintain QA and QC systems with written SOPs.
C) Accept this site and plan to undertake routine safety evaluations of the IP.
D) Before accepting this site, report the risk to the trial sponsor and await their decision.

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