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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

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. Protocol
B. ICF
C. Package insert
D. IB

Question 2

Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A. Notify the PI.
B. Call the participant to return for an unscheduled visit.
C. Notify the sponsor.
D. Report a protocol deviation to the IRB/IEC.

Question 3

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A. A total of five members.
B. One member who is independent of the institution/trial site.
C. One member whose primary area of interest is in the same scientific area.
D. One member of the site's QA group.

Question 4

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

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

Question 5

A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A. Clinical Study Protocol
B. IDMC/DSMB Report
C. Clinical Study Report
D. Investigator Brochure

Solutions: