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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E11 Pediatric Trials
  • 2. E6(R2)/E6(R3) Good Clinical Practice
  • 3. E8 General Considerations for Clinical Trials
  • 4. E2A Expedited Reporting
  • 5. E9 Statistical Principles
- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
Clinical Study Operations15%- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
Study Design and Conduct17%- Study implementation
  • 1. Site selection and activation
  • 2. Investigational product management
  • 3. Study monitoring and oversight
- Study planning
  • 1. Protocol development and amendments
  • 2. Study population and eligibility criteria
  • 3. Sample size and statistical considerations
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. Informed consent development and review
  • 2. Standard of care vs protocol requirements
  • 3. Continuity of medical care
- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
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
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. Case report form design and completion
  • 2. Electronic data capture systems

ACRP Certified Professional Sample Questions:

Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

  • A. Train the research coordinator on the required study assessments schedule.
  • B. Identify critical processes and data during protocol development.
  • C. Determine the quality tolerance limits for data transcription errors.
  • D. Perform a periodic review to see if the quality methods are effective and relevant.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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

Correct Answer: B  🗳️

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

Correct Answer: D  🗳️

Explanation: Only visible for iPassleader members. You can sign-up / login (it's free).

Which strategy is used to safeguard subject privacy?

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

Correct Answer: A  🗳️

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

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

Correct Answer: C  🗳️

Explanation: Only visible for iPassleader members. You can sign-up / login (it's free).

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