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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Any trial-related duties can be documented as transferred by verbal agreement.
B) The IRB/IEC must approve the transfer of duties to a CRO.
C) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
D) All duties transferred to a CRO should be specified in writing.

2. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How likely are patients at high risk of cancer going to develop cancer during the study?
B) How effective is the drug at treating patients that have been previously diagnosed with cancer?
C) How does the risk of developing cancer compare to the anticipated side effects from the drug?
D) How willing are current patients to participate in a trial with potentially serious side effects?

3. Which document confirms the PI's agreement to permit auditing at the study site?

A) Protocol
B) ICF
C) Delegation Log
D) IB

4. After the completion or termination of a clinical trial, who should store the enrollment log?

A) Regulatory authority
B) Sponsor
C) PI
D) CRO

5. Centralized monitoring can:

A) Confirm why sites are deviating from the protocol.
B) Identify IP accountability and storage issues.
C) Enable appropriate stratification of subject enrollment.
D) Indicate the need to send monitors to perform onsite visits.

Solutions: