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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Topic 2: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 3: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Topic 4: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 5: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
ACRP Certified Professional Sample Questions:
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:
- A. Regulatory authority.
- B. Sponsor.
- C. IRB/IEC.
- D. Medical monitor.
Correct Answer: B 🗳️
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A root cause analysis should be:
- A. Validated before use in a CAPA.
- B. Focused on issues of non-compliance.
- C. Specific to a clinical trial.
- D. Written by the investigator.
Correct Answer: B 🗳️
Explanation: Only visible for ExamTorrent members. You can sign-up / login (it's free).
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
- A. No, the PI does not have the resources to perform all protocol-required procedures.
- B. No, the PI is taking part in too many ongoing studies to participate in this study.
- C. Yes, the PI can perform other imaging scans instead of the PET scans.
- D. Yes, the PI has a sufficient patient population to take part in this study.
Correct Answer: A 🗳️
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Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?
- A. Train the research coordinator on the required study assessments schedule.
- B. Perform a periodic review to see if the quality methods are effective and relevant.
- C. Identify critical processes and data during protocol development.
- D. Determine the quality tolerance limits for data transcription errors.
Correct Answer: C 🗳️
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Who ensures information regarding payments to subjects is documented in a written consent form?
- A. IRB/IEC
- B. Coordinator
- C. Sponsor
- D. PI
Correct Answer: A 🗳️
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