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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Ethical and Participant Safety Considerations | - Human subject protection
|
| Topic 2: Data Management and Documentation | - Clinical trial documentation
|
| Topic 3: Quality Management | - Audit and inspection readiness
|
| Topic 4: Professional Responsibilities | - Leadership and professionalism
|
| Topic 5: Clinical Trial Operations | - Study conduct
|
ACRP Certified Professional Sample Questions:
1. 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.
2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
C) Training records of site personnel on study protocol, and their study-related duties and functions.
D) A monitoring report that identifies deviation from the approved protocol.
3. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
A) Risk-based audits of CRO activities as delegated
B) Central monitoring of data fields by sponsor
C) Co-monitoring of CRO site visits
D) Pre-qualification assessment of CRO
4. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?
A) This qualifies for prompt reporting to the IRB/IEC within 15 business days.
B) This needs to be reported to the patient's primary care physician.
C) This needs to be reported to the regulatory authorities within 10 business days.
D) This qualifies for expedited reporting to the sponsor.
5. Which of the following elements of the Informed Consent are NOT required?
A) Statement that study involves research
B) Subject legal rights can be waived
C) A description of potential benefits
D) A description of any reasonably foreseeable risks or discomforts
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: D | Question # 5 Answer: B |
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