ACRP ACRP-CP Q&A - in .pdf

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Oct 01, 2026
  • Q & A: 127 Questions and Answers
  • Printable ACRP ACRP-CP PDF Format. It is an electronic file format regardless of the operating system platform.
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ACRP ACRP-CP Q&A - Testing Engine

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Oct 01, 2026
  • Q & A: 127 Questions and Answers
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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

Question #1

An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

  • A. Independent qualified individuals.
  • B. Investigators participating in the trial.
  • C. Executive board members.
  • D. Regulatory authority expert advisors.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #2

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

Correct Answer: C  🗳️

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Question #3

A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

  • A. Parallel Group
  • B. Group sequential
  • C. Crossover
  • D. Factorial
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

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Question #4

A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

  • A. IDMC/DSMB Report
  • B. Clinical Study Protocol
  • C. Clinical Study Report
  • D. Investigator Brochure
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

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Question #5

Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

  • A. Ensure submission of a data management plan to the regulatory authorities.
  • B. Develop a plan that describes the monitoring approach for a clinical study.
  • C. Conduct annual reviews of the protocol and accompanying study documents.
  • D. Ensure there is an accompanying written record that describes the consent process.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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