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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Study Operations | - Study planning and initiation - Study conduct and oversight |
| Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
ACRP Certified Professional Sample Questions:
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
- A. The CRC is responsible for identifying the relationship of an SAE to the IP.
- B. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
- C. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
- D. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
Correct Answer: B 🗳️
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A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?
- A. To establish a procedure for PI oversight of protocol deviations
- B. To determine if a protocol amendment is needed
- C. To determine if the deviations invalidate the data
- D. To escalate corrective actions to the regulatory authority
Correct Answer: A 🗳️
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Which strategy is used to safeguard subject privacy?
- A. Conduct subject-related conversations in controlled environments.
- B. Utilize subject initials on correspondence.
- C. Email updated enrollment logs to the CRA.
- D. Store source documentation in the CRC's office.
Correct Answer: A 🗳️
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A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?
- A. After the protocol amendment is approved by the IRB/IEC
- B. As soon as the protocol amendment is submitted to the IRB/IEC
- C. When the need for the additional data is discovered
- D. After the original planned data collection is completed
Correct Answer: A 🗳️
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Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?
- A. Report the AE to the sponsor.
- B. Call the medical monitor.
- C. Consult the IB.
- D. Administer rescue medication.
Correct Answer: D 🗳️
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