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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A. Regulatory Agency
B. Sponsor
C. CRC
D. PI

Question 2

In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A. Privacy controls
B. Blinding
C. Placebo-controlled
D. Randomization

Question 3

Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

A. Investigator
B. CRO
C. Sponsor
D. CRC

Question 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. Report this incident immediately to the sponsor and leave the treatment decision to them.
B. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
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.

Question 5

While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A. There are no circumstances under which this person can be enrolled.
B. Have the Principal Investigator consent the person.
C. Get an impartial witness involved in consenting this person.
D. Locate a translator and have them work with the person.

Solutions: