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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| 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:
A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?
- A. Attributable
- B. Contemporaneous
- C. Complete
- D. Original
Correct Answer: C 🗳️
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The investigator/institution should permit:
- A. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
- B. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
- C. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
- D. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
Correct Answer: B 🗳️
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In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
- A. CRC
- B. CRA
- C. IRB/IEC
- D. PI
Correct Answer: D 🗳️
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An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?
- A. Investigator at each site
- B. Regulatory authority
- C. Study sponsor
- D. Original reporting investigator
Correct Answer: C 🗳️
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The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
- A. Occurrence of known side effects of the IP
- B. Impact of an approved vaccine against the disease
- C. Use of concomitant medications to treat the symptoms
- D. Time to occurrence of symptoms of the disease
Correct Answer: D 🗳️
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