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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Data Management and Documentation | - Data integrity
|
| Topic 2: Ethical and Participant Safety Considerations | - Human subject protection
|
| Topic 3: Clinical Trial Operations | - Study start-up activities
|
| Topic 4: Professional Responsibilities | - Leadership and professionalism
|
| Topic 5: Quality Management | - Risk management
|
ACRP Certified Professional Sample Questions:
A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?
- A. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
- B. Report this incident immediately to the sponsor and leave the treatment decision to them.
- C. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
- D. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
Correct Answer: A 🗳️
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One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
- A. Allowing real-time access for data review in the eCRF.
- B. Comparing source document data to other data recorded in the same study time period.
- C. Recording data on source documents at the time the data are collected during the conduct of the study.
- D. Recording the date and time each data element is entered onto the source document.
Correct Answer: C 🗳️
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Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
- A. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
- B. Training records of site personnel on study protocol, and their study-related duties and functions.
- C. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
- D. A monitoring report that identifies deviation from the approved protocol.
Correct Answer: B 🗳️
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
- A. Sponsor
- B. Investigator
- C. CRO
- D. CRC
Correct Answer: A 🗳️
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An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
- A. Investigators participating in the trial.
- B. Independent qualified individuals.
- C. Regulatory authority expert advisors.
- D. Executive board members.
Correct Answer: B 🗳️
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