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Last Updated: Sep 15, 2026
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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Professional Responsibilities | - Communication and collaboration
|
| Topic 2: Clinical Trial Operations | - Study start-up activities
|
| Topic 3: Data Management and Documentation | - Data integrity
|
| Topic 4: Quality Management | - Risk management
|
| Topic 5: Ethical and Participant Safety Considerations | - Human subject protection
|
ACRP Certified Professional Sample Questions:
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
- A. Redact subject identification for privacy protection.
- B. Deny the request until the sponsor approves.
- C. Allow access to the entire records.
- D. Consult with the IRB/IEC first.
Correct Answer: C 🗳️
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Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
- A. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
- B. Training records of site personnel on study protocol, and their study-related duties and functions.
- C. A monitoring report that identifies deviation from the approved protocol.
- D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
Correct Answer: B 🗳️
Which one of the following is a primary objective of a Phase III study of a new IP?
- A. To establish dose information
- B. To show superiority over another treatment
- C. To demonstrate or confirm therapeutic benefit
- D. To establish the safety profile
Correct Answer: C 🗳️
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A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?
- A. QA Department
- B. Data Manager
- C. Sponsor
- D. Monitor
Correct Answer: D 🗳️
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An impartial witness should be present during the entire informed consent discussion when:
- A. A subject has been determined to be vulnerable.
- B. An interpreter is translating the consent form for a subject.
- C. A parent/guardian is consenting for a minor subject.
- D. A legally acceptable representative is unable to read.
Correct Answer: D 🗳️
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