ACRP ACRP-CP actual dump : ACRP Certified Professional Exam

ACRP-CP
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Oct 07, 2026
  • Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E8 General Considerations for Clinical Trials
  • 2. E2A Expedited Reporting
  • 3. E9 Statistical Principles
  • 4. E11 Pediatric Trials
  • 5. E6(R2)/E6(R3) Good Clinical Practice
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
Clinical Study Operations15%- Project management
  • 1. Timeline and budget management
  • 2. Vendor and stakeholder management
- Site management
  • 1. Study documentation and record keeping
  • 2. Site personnel training and delegation
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. Data validation and cleaning
  • 2. Query management and resolution
- Data collection
  • 1. Case report form design and completion
  • 2. Electronic data capture systems
- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
Study Design and Conduct17%- Study planning
  • 1. Protocol development and amendments
  • 2. Sample size and statistical considerations
  • 3. Study population and eligibility criteria
- Study implementation
  • 1. Investigational product management
  • 2. Site selection and activation
  • 3. Study monitoring and oversight
Ethical and Participant Safety Considerations19%- 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
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Informed consent development and review
  • 3. Continuity of medical care

ACRP Certified Professional Sample Questions:

Question #1

After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

  • A. Submit the diary to the sponsor for approval.
  • B. No approval is necessary: give the diary to each subject.
  • C. Submit the diary to the regulatory authority for approval.
  • D. Submit the diary to the IRB/IEC for approval.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #2

An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

  • A. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
  • B. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
  • C. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
  • D. Update the IB to add the risk of infection and submit to the sponsor for approval.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #3

Which one of the following is a primary objective of a Phase III study of a new IP?

  • A. To establish the safety profile
  • B. To demonstrate or confirm therapeutic benefit
  • C. To show superiority over another treatment
  • D. To establish dose information
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #4

Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

  • A. CRO
  • B. Sponsor-Investigator
  • C. Regulatory authority
  • D. IRB/IEC
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #5

During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

  • A. Verify compliance with IP regimen.
  • B. Validate protocol endpoints.
  • C. Conduct safety analysis.
  • D. Evaluate study data.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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