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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A. 2.6 mg/dL
B. 3.6 mg/dL
C. 3.0 mg/dL
D. 1.8 mg/dL

Question 2

Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A. Dispose of IP and request replacement from sponsor.
B. Quarantine IP without registering in IWRS and request replacement from sponsor.
C. Register IP in IWRS, quarantine and notify sponsor of the excursion.
D. Register IP in IWRS and continue with subject allocation.

Question 3

A deferred consent can take place in which of the following situations?

A. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
B. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
C. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
D. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.

Question 4

Who is responsible for submitting a protocol amendment to the IRB/IEC?

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

Question 5

The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A. A family member
B. A member of the research team
C. A legally acceptable representative
D. A witness

Solutions: