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ACRP Certified Professional : ACRP-CP

ACRP-CP Exam Simulator
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Sep 28, 2026
  • Q & A: 127 Questions and Answers
  • ACRP ACRP-CP Q&A - in .pdf

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ACRP ACRP-CP exam simulator

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

Question #1

A study protocol must contain which of the following elements?

  • A. Chemical structure of the IP
  • B. Data management plan
  • C. Participant reimbursement details
  • D. Description of statistical methods
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #2

The IB contains which of the following sections?

  • A. Participant eligibility criteria
  • B. Participant dosing schedule
  • C. IP preparation instructions
  • D. Known pharmacokinetic effects
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #3

Which document confirms the PI's agreement to permit auditing at the study site?

  • A. IB
  • B. Protocol
  • C. ICF
  • D. Delegation Log
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

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Question #4

A serious unexpected ADR is one:

  • A. Where the severity of the reaction is not consistent with IB.
  • B. Severity and nature of the reaction is consistent with protocol.
  • C. That results in the death of the subject.
  • D. That does not need to be reported to the IRB/IEC.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #5

The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

  • A. PI
  • B. Regulatory Agency
  • C. CRC
  • D. Sponsor
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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