Exam Name: ACRP Certified Professional Exam
Certification Provider: ACRP
Corresponding Certification: ACRP Certified Professional
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- Total Questions: 127
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- Total Questions: 127
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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| 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 |
| Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| 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 root cause analysis should be:
- A. Validated before use in a CAPA.
- B. Written by the investigator.
- C. Specific to a clinical trial.
- D. Focused on issues of non-compliance.
Correct Answer: D 🗳️
Explanation: Only visible for 2Pass4sure members. You can sign-up / login (it's free).
When assessing the monitoring needs for a study, sponsors should:
- A. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
- B. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
- 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: A 🗳️
Explanation: Only visible for 2Pass4sure members. You can sign-up / login (it's free).
Which of the following is a conflict of interest for a PI conducting a study?
- A. A PI that presents at an investigator meeting
- B. A PI who is a key opinion leader, writes the protocol
- C. A PI that votes on the IRB/IEC approval of the protocol
- D. A PI who receives payment for the study
Correct Answer: C 🗳️
Explanation: Only visible for 2Pass4sure members. You can sign-up / login (it's free).
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
- A. Conduct annual reviews of the protocol and accompanying study documents.
- 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. Ensure submission of a data management plan to the regulatory authorities.
Correct Answer: B 🗳️
Explanation: Only visible for 2Pass4sure members. You can sign-up / login (it's free).
The sponsor should supply a PI with the IP after:
- A. Approval/favorable opinion from IRB/IEC and regulatory authority.
- B. Submission of documents to IRB/IEC and regulatory authority for review.
- C. Approval of protocol by the PI.
- D. Approval of protocol by the sponsor.
Correct Answer: A 🗳️
Explanation: Only visible for 2Pass4sure members. You can sign-up / login (it's free).
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