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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A. Ensure submission of a data management plan to the regulatory authorities.
B. Ensure there is an accompanying written record that describes the consent process.
C. Develop a plan that describes the monitoring approach for a clinical study.
D. Conduct annual reviews of the protocol and accompanying study documents.

Question 2

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

Question 3

Which of the following statements is TRUE about an EDC system?

A. IRB/IEC approval is required before the use of the computerized system.
B. The eCRF should be an exact page-by-page replica of the paper CRF.
C. A separate workstation should be made available for the monitor.
D. There should be an audit trail to track data entries, deletions, and changes.

Question 4

An impartial witness should be present during the entire informed consent discussion when:

A. A parent/guardian is consenting for a minor subject.
B. An interpreter is translating the consent form for a subject.
C. A legally acceptable representative is unable to read.
D. A subject has been determined to be vulnerable.

Question 5

While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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

Solutions: