ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Oct 02, 2026     Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

SectionObjectives
Data Management and Documentation- Clinical trial documentation
  • 1. Essential documents
  • 2. Source documentation
- Data integrity
  • 1. Query resolution
  • 2. Data collection
Professional Responsibilities- Communication and collaboration
  • 1. Cross-functional teamwork
  • 2. Stakeholder communication
- Leadership and professionalism
  • 1. Professional ethics
  • 2. Decision making
Ethical and Participant Safety Considerations- Regulatory compliance
  • 1. IRB and ethics requirements
  • 2. ICH GCP adherence
- Human subject protection
  • 1. Informed consent
  • 2. Participant rights
Quality Management- Audit and inspection readiness
  • 1. Inspection preparation
  • 2. Compliance monitoring
- Risk management
  • 1. Corrective and preventive actions
  • 2. Quality assurance
Clinical Trial Operations- Study conduct
  • 1. Participant management
  • 2. Safety reporting
- Study start-up activities
  • 1. Protocol implementation
  • 2. Site preparation

ACRP Certified Professional Sample Questions:

Question #1

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. Co-monitoring of CRO site visits
  • C. Central monitoring of data fields by sponsor
  • D. Pre-qualification assessment of CRO
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #2

AEs that occur between study visits of a clinical trial should be evaluated by the:

  • A. Principal Investigator
  • B. Medical monitor
  • C. Subject's primary care physician
  • D. Study pharmacovigilance physician
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Explanation: Only visible for Pass4guide members. You can sign-up / login (it's free).

Question #3

A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

  • A. Sponsor.
  • B. Medical monitor.
  • C. Regulatory authority.
  • D. IRB/IEC.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #4

A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

  • A. ICF
  • B. Protocol
  • C. IB
  • D. Package insert
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #5

A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

  • A. Continue reporting temperature excursions per the pharmacy manual guidelines.
  • B. Return all IP and request the CRO/Sponsor to directly ship IP to participants.
  • C. Install an air cooler requiring regular water refills to maintain the room temperature.
  • D. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

Explanation: Only visible for Pass4guide members. You can sign-up / login (it's free).

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