ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Sep 26, 2026
  • Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

Question #1

All of the following are examples of what monitors review EXCEPT:

  • A. Potential patient medical records for eligibility prior to the informed consent process.
  • B. The signed ICF retained in the participant's study file.
  • C. Documentation in the participant's medical record of study drug administration.
  • D. Regulatory binder which includes copies of current certifications for all laboratories.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #2

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

  • A. ICF
  • B. Protocol
  • C. Delegation Log
  • D. IB
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Correct Answer: A  🗳️

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Question #3

Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

  • A. Applicable regulatory authorities
  • B. Applicable site SOPs
  • C. PI
  • D. Sponsor
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #4

One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

  • A. Comparing source document data to other data recorded in the same study time period.
  • B. Recording the date and time each data element is entered onto the source document.
  • C. Allowing real-time access for data review in the eCRF.
  • D. Recording data on source documents at the time the data are collected during the conduct of the study.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #5

A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

  • A. Location of stored trial records
  • B. Length of time to receive the approved trial device
  • C. Information to be included in the advertising flyer
  • D. Availability of qualified staff to conduct the trial
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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