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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A) Sponsor
B) CRA
C) CRO
D) Data Manager

2. A serious unexpected ADR is one:

A) That does not need to be reported to the IRB/IEC.
B) That results in the death of the subject.
C) Where the severity of the reaction is not consistent with IB.
D) Severity and nature of the reaction is consistent with protocol.

3. 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) Protocol
C) ICF
D) IB

4. 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.

5. Who ensures information regarding payments to subjects is documented in a written consent form?

A) PI
B) Sponsor
C) IRB/IEC
D) Coordinator

Solutions: