ACRP ACRP-CP exam : ACRP Certified Professional Exam

ACRP-CP Exam Simulator
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Sep 21, 2026
  • Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

Question #1

Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

  • A. A monitoring report that identifies deviation from the approved protocol.
  • B. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
  • C. Training records of site personnel on study protocol, and their study-related duties and functions.
  • D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Question #2

Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

  • A. Data Manager
  • B. Sponsor
  • C. CRO
  • D. CRA
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #3

Centralized monitoring can:

  • A. Indicate the need to send monitors to perform onsite visits.
  • B. Identify IP accountability and storage issues.
  • C. Confirm why sites are deviating from the protocol.
  • D. Enable appropriate stratification of subject enrollment.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #4

The IB contains which of the following sections?

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

Correct Answer: D  🗳️

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Question #5

Who must be blinded in a double-blind study in order to prevent bias?

  • A. IRB/IEC
  • B. Subject
  • C. Pharmacist
  • D. Data entry staff
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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