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ACRP ACRP-CP exam : ACRP Certified Professional Exam

ACRP-CP Exam Simulator
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Oct 10, 2026
  • Q & A: 127 Questions and Answers
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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- ICH Guidelines
  • 1. E9 Statistical Principles
  • 2. E6(R2)/E6(R3) Good Clinical Practice
  • 3. E8 General Considerations for Clinical Trials
  • 4. E11 Pediatric Trials
  • 5. E2A Expedited Reporting
- International standards
  • 1. Declaration of Helsinki
Ethical and Participant Safety Considerations19%- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Informed consent development and review
  • 3. Continuity of medical care
- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
Study Design and Conduct17%- Study implementation
  • 1. Investigational product management
  • 2. Study monitoring and oversight
  • 3. Site selection and activation
- Study planning
  • 1. Study population and eligibility criteria
  • 2. Protocol development and amendments
  • 3. Sample size and statistical considerations
Clinical Study Operations15%- Project management
  • 1. Timeline and budget management
  • 2. Vendor and stakeholder management
- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
Data Management and Informatics17%- Data quality control
  • 1. Query management and resolution
  • 2. Data validation and cleaning
- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
- Data collection
  • 1. Electronic data capture systems
  • 2. Case report form design and completion
Professionalism and Ethical Practice15%- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
- Continuous improvement
  • 1. Professional development and education
  • 2. Quality assurance and process improvement

ACRP Certified Professional Sample Questions:

Question #1

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

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

Correct Answer: B  🗳️

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Question #2

An impartial witness should be present during the entire informed consent discussion when:

  • A. A parent/guardian is consenting for a minor subject.
  • B. A subject has been determined to be vulnerable.
  • C. A legally acceptable representative is unable to read.
  • D. An interpreter is translating the consent form for a subject.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

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Question #3

The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

  • A. Schedule a site initiation visit
  • B. Obtain IRB/IEC approval
  • C. Ship/receive IP
  • D. Verify subject eligibility
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #4

A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

  • A. Monitor
  • B. Data Manager
  • C. QA Department
  • D. Sponsor
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #5

Which strategy is used to safeguard subject privacy?

  • A. Utilize subject initials on correspondence.
  • B. Conduct subject-related conversations in controlled environments.
  • C. Email updated enrollment logs to the CRA.
  • D. Store source documentation in the CRC's office.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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