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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals
- ICH Guidelines
  • 1. E8 General Considerations for Clinical Trials
  • 2. E6(R2)/E6(R3) Good Clinical Practice
  • 3. E9 Statistical Principles
  • 4. E11 Pediatric Trials
  • 5. E2A Expedited Reporting
Professionalism and Ethical Practice15%- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
- Continuous improvement
  • 1. Professional development and education
  • 2. Quality assurance and process improvement
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
Data Management and Informatics17%- 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
- Data collection
  • 1. Case report form design and completion
  • 2. Electronic data capture systems
Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Site selection and activation
  • 3. Investigational product management
- Study planning
  • 1. Study population and eligibility criteria
  • 2. Sample size and statistical considerations
  • 3. Protocol development and amendments
Ethical and Participant Safety Considerations19%- 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
- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication

ACRP Certified Professional Sample Questions:

Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

  • A. How does the risk of developing cancer compare to the anticipated side effects from the drug?
  • B. How willing are current patients to participate in a trial with potentially serious side effects?
  • C. How effective is the drug at treating patients that have been previously diagnosed with cancer?
  • D. How likely are patients at high risk of cancer going to develop cancer during the study?
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

  • A. Study sponsor
  • B. Original reporting investigator
  • C. Regulatory authority
  • D. Investigator at each site
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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The sponsor should supply a PI with the IP after:

  • A. Submission of documents to IRB/IEC and regulatory authority for review.
  • B. Approval of protocol by the sponsor.
  • C. Approval of protocol by the PI.
  • D. Approval/favorable opinion from IRB/IEC and regulatory authority.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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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. Regulatory binder which includes copies of current certifications for all laboratories.
  • C. The signed ICF retained in the participant's study file.
  • D. Documentation in the participant's medical record of study drug administration.
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Correct Answer: A  🗳️

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A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

  • A. Monitor
  • B. Sponsor
  • C. QA Department
  • D. Data Manager
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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