Exam Name: ACRP Certified Professional Exam
Certification Provider: ACRP
Corresponding Certification: ACRP Certified Professional
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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 2: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Topic 3: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 4: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 5: Study Operations | - Study conduct and oversight - Study planning and initiation |
ACRP Certified Professional Sample Questions:
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
- A. Randomization
- B. Privacy controls
- C. Blinding
- D. Placebo-controlled
Correct Answer: A 🗳️
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SAEs must be reported immediately by the site to the:
- A. Regulatory agency.
- B. IRB/IEC.
- C. DSMB/IDMC.
- D. Sponsor.
Correct Answer: D 🗳️
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A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?
- A. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
- B. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
- C. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
- D. Report this incident immediately to the sponsor and leave the treatment decision to them.
Correct Answer: C 🗳️
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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. Investigator
- C. Sponsor
- D. Health authority
Correct Answer: C 🗳️
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When assessing the monitoring needs for a study, sponsors should:
- A. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
- B. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
- C. Use central monitoring instead of conducting physical monitoring visits at sites.
- D. Permit PIs to select a monitor for their site as long as they are independent of the PI.
Correct Answer: B 🗳️
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