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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Data Management and Documentation | - Data integrity
|
| Topic 2: Clinical Trial Operations | - Study start-up activities
|
| Topic 3: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 4: Quality Management | - Risk management
|
| Topic 5: Professional Responsibilities | - Leadership and professionalism
|
ACRP Certified Professional Sample Questions:
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 write a note to file.
- B. The CRC should amend the medical chart.
- C. The PI should notify the monitor.
- D. The PI should amend the medical chart.
Correct Answer: D 🗳️
Explanation: Only visible for ActualCollection members. You can sign-up / login (it's free).
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
- A. CRC
- B. Sponsor
- C. Investigator
- D. CRA
Correct Answer: C 🗳️
Explanation: Only visible for ActualCollection members. You can sign-up / login (it's free).
A study protocol must contain which of the following elements?
- A. Data management plan
- B. Chemical structure of the IP
- C. Participant reimbursement details
- D. Description of statistical methods
Correct Answer: D 🗳️
Explanation: Only visible for ActualCollection members. You can sign-up / login (it's free).
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:
- A. Sponsor.
- B. IRB/IEC.
- C. Regulatory authority.
- D. Medical monitor.
Correct Answer: A 🗳️
Explanation: Only visible for ActualCollection members. You can sign-up / login (it's free).
At a close-out visit, which document should be retained only at the site?
- A. IP accountability
- B. Final trial close-out monitoring report
- C. Treatment allocation
- D. Subject identification code list
Correct Answer: D 🗳️
Explanation: Only visible for ActualCollection members. You can sign-up / login (it's free).
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