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ACRP Certified Professional Exam: ACRP-CP Exam

"ACRP Certified Professional Exam", also known as ACRP-CP exam, is a ACRP Certification. With the complete collection of questions and answers, BraindumpsPass has assembled to take you through 127 Q&As to your ACRP-CP Exam preparation. In the ACRP-CP exam resources, you will cover every field and category in ACRP Certified Professional Certification helping to ready you for your successful ACRP Certification.

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  • Updated on: Sep 14, 2026
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  • Updated on: Sep 14, 2026
  • No. of Questions: 127 Questions & Answers

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: 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. Data integrity and security
  • 2. Database lock and data transfer
Topic 2: Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
- Study planning
  • 1. Sample size and statistical considerations
  • 2. Protocol development and amendments
  • 3. Study population and eligibility criteria
Topic 3: Clinical Study Operations15%- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
Topic 4: 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. Continuity of medical care
  • 2. Standard of care vs protocol requirements
  • 3. Informed consent development and review
- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
Topic 5: Regulatory and Compliance Requirements17%- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E2A Expedited Reporting
  • 2. E11 Pediatric Trials
  • 3. E6(R2)/E6(R3) Good Clinical Practice
  • 4. E8 General Considerations for Clinical Trials
  • 5. E9 Statistical Principles
Topic 6: 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

ACRP Certified Professional Sample Questions:

When assessing the monitoring needs for a study, sponsors should:

  • A. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
  • B. Use central monitoring instead of conducting physical monitoring visits at sites.
  • C. Permit PIs to select a monitor for their site as long as they are independent of the PI.
  • D. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
Answer: A

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A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

  • A. Install an air cooler requiring regular water refills to maintain the room temperature.
  • B. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
  • C. Return all IP and request the CRO/Sponsor to directly ship IP to participants.
  • D. Continue reporting temperature excursions per the pharmacy manual guidelines.
Answer: B

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Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

  • A. Monitor
  • B. Coordinator
  • C. Sponsor
  • D. Investigator
Answer: D

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The sponsor should supply a PI with the IP after:

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

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A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

  • A. To determine if a protocol amendment is needed
  • B. To determine if the deviations invalidate the data
  • C. To establish a procedure for PI oversight of protocol deviations
  • D. To escalate corrective actions to the regulatory authority
Answer: C

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