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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

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

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

3. All site financial matters pertaining to a trial are listed in what document?

A) Financial disclosure
B) Protocol
C) Signed contract
D) Informed consent form

4. At a close-out visit, which document should be retained only at the site?

A) IP accountability
B) Subject identification code list
C) Treatment allocation
D) Final trial close-out monitoring report

5. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A) The CRC is responsible for identifying the relationship of an SAE to the IP.
B) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
C) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
D) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

Solutions: