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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Data Management and Documentation | - Clinical trial documentation
|
| Topic 2: Clinical Trial Operations | - Study start-up activities
|
| Topic 3: Professional Responsibilities | - Communication and collaboration
|
| Topic 4: Quality Management | - Risk management
|
| Topic 5: Ethical and Participant Safety Considerations | - Human subject protection
|
ACRP Certified Professional Sample Questions:
Question 1
The PI may assign responsibility for IP accountability to the pharmacist provided they are:
A. Approved by the IRB/IEC.
B. Licensed to practice medicine.
C. Under the supervision of the PI.
D. An employee of the institution.
Question 2
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. Data Manager
B. QA Department
C. Monitor
D. Sponsor
Question 3
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?
A. Before accepting this site, report the risk to the trial sponsor and await their decision.
B. Accept this site and implement and maintain QA and QC systems with written SOPs.
C. Accept this site and plan to undertake routine safety evaluations of the IP.
D. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
Question 4
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
A. Any trial-related duties can be documented as transferred by verbal agreement.
B. All duties transferred to a CRO should be specified in writing.
C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
D. The IRB/IEC must approve the transfer of duties to a CRO.
Question 5
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
A. Review the content for ethically or morally sensitive issues.
B. Assure the ads do not impinge on confidentiality agreements.
C. Safeguard the rights, safety, and well-being of all potential subjects.
D. Confirm subjects receive the appropriate reimbursement.
Solutions:
| Question 1 Answer: C | Question 2 Answer: C | Question 3 Answer: A | Question 4 Answer: B | Question 5 Answer: C |
