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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Topic 2: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Topic 3: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 4: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Topic 5: Study Operations | - Study conduct and oversight - Study planning and initiation |
ACRP Certified Professional Sample Questions:
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. Health authority
- B. Sponsor
- C. DSMB/IDMC
- D. Investigator
Correct Answer: B 🗳️
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A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?
- A. The list of comparable technology solutions was not included.
- B. The number of users with access was not defined.
- C. The number of unique eCRF templates was not specified.
- D. The frequency of data backup was not defined.
Correct Answer: D 🗳️
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Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
- A. CRC
- B. PI
- C. CRA
- D. Sponsor
Correct Answer: B 🗳️
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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. Original
- B. Complete
- C. Attributable
- D. Contemporaneous
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. PI
- C. CRA
- D. IRB/IEC
Correct Answer: B 🗳️
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