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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Study Design and Conduct | 17% | - Study implementation
|
| Topic 2: Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Topic 3: Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
| Topic 4: Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Topic 5: Data Management and Informatics | 17% | - Data quality control
|
| Topic 6: Clinical Study Operations | 15% | - Project management
|
ACRP Certified Professional Sample Questions:
Question #1
The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?
A. The CRC should amend the medical chart.
B. The PI should amend the medical chart.
C. The PI should notify the monitor.
D. The CRC should write a note to file.
Question #2
Which one of the following is a primary objective of a Phase III study of a new IP?
A. To demonstrate or confirm therapeutic benefit
B. To show superiority over another treatment
C. To establish dose information
D. To establish the safety profile
Question #3
Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A. Sponsor
B. Applicable regulatory authorities
C. PI
D. Applicable site SOPs
Question #4
A deferred consent can take place in which of the following situations?
A. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
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, regardless of the emergency situation described in the protocol.
D. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
Question #5
A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?
A. No treatment
B. Active control
C. Placebo
D. Alternate dose
Solutions:
| Question #1 Correct Answer: B | Question #2 Correct Answer: A | Question #3 Correct Answer: B | Question #4 Correct Answer: B | Question #5 Correct Answer: C |
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