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 |
|---|---|
| Study Operations | - Study planning and initiation - Study conduct and oversight |
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
ACRP Certified Professional Sample Questions:
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
- A. Allowing real-time access for data review in the eCRF.
- B. Recording data on source documents at the time the data are collected during the conduct of the study.
- C. Comparing source document data to other data recorded in the same study time period.
- D. Recording the date and time each data element is entered onto the source document.
Correct Answer: B 🗳️
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Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
- A. Ensure submission of a data management plan to the regulatory authorities.
- B. Develop a plan that describes the monitoring approach for a clinical study.
- C. Conduct annual reviews of the protocol and accompanying study documents.
- D. Ensure there is an accompanying written record that describes the consent process.
Correct Answer: B 🗳️
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Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
- A. 1.8 mg/dL
- B. 3.6 mg/dL
- C. 2.6 mg/dL
- D. 3.0 mg/dL
Correct Answer: D 🗳️
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Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
- A. Register IP in IWRS, quarantine and notify sponsor of the excursion.
- B. Quarantine IP without registering in IWRS and request replacement from sponsor.
- C. Dispose of IP and request replacement from sponsor.
- D. Register IP in IWRS and continue with subject allocation.
Correct Answer: A 🗳️
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Which strategy is used to safeguard subject privacy?
- A. Store source documentation in the CRC's office.
- B. Conduct subject-related conversations in controlled environments.
- C. Email updated enrollment logs to the CRA.
- D. Utilize subject initials on correspondence.
Correct Answer: B 🗳️
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