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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

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

3. Who on the local site research study team is accountable for the unblinding documentation of IP?

A) Regulatory manager
B) Pharmacist
C) PI
D) CRC

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

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

5. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Coordinator
C) Investigator
D) Sponsor

Solutions: