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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Study Operations | - Study conduct and oversight - Study planning and initiation |
ACRP Certified Professional Sample Questions:
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
- A. Investigators participating in the trial.
- B. Executive board members.
- C. Regulatory authority expert advisors.
- D. Independent qualified individuals.
Correct Answer: D 🗳️
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A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?
- A. DSMB/IDMC
- B. Health authority
- C. Investigator
- D. Sponsor
Correct Answer: D 🗳️
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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. Yes, the PI has a sufficient patient population to take part in this study.
- B. Yes, the PI can perform other imaging scans instead of the PET scans.
- C. No, the PI is taking part in too many ongoing studies to participate in this study.
- D. No, the PI does not have the resources to perform all protocol-required procedures.
Correct Answer: D 🗳️
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Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
- A. Ensure submission of a data management plan to the regulatory authorities.
- B. Develop a plan that describes the monitoring approach for a clinical study.
- C. Ensure there is an accompanying written record that describes the consent process.
- D. Conduct annual reviews of the protocol and accompanying study documents.
Correct Answer: B 🗳️
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Who is responsible for the ongoing safety evaluation of the IP?
- A. IRB/IEC
- B. Regulatory agency
- C. PI
- D. Sponsor
Correct Answer: D 🗳️
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