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Updated: Aug 18, 2026

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ACRP ACRP-CP Exam Overview:

Certification Vendor:Association of Clinical Research Professionals (ACRP)
Exam Name:ACRP Certified Professional Exam
Exam Number:ACRP-CP
Related Certifications:ACRP Certified Clinical Research Associate (CCRA)
ACRP Certified Clinical Research Coordinator (CCRC)
ACRP Certified Principal Investigator (CPI)
Real Exam Qty:125 (100 scored, 25 pre-test)
Exam Price:$435 – $600
Exam Duration:180 minutes
Available Languages:English
Passing Score:Scaled score of 600 or higher
Exam Format:Multiple-choice questions, Recall questions, Scenario-based questions
Certificate Validity Period:3 years
Recommended Training:ACRP Official Training Resources
Exam Registration:ACRP Official Registration
Sample Questions:ACRP ACRP-CP Sample Questions
Exam Way:Online remote proctored or in-person at PSI test centers
Pre Condition:3,000 hours verifiable clinical research work experience; or 1,500 hours plus clinical research degree
Official Syllabus URL:https://acrpnet.org/certification/acrp-cp-certification

ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E2A Expedited Reporting
  • 2. E11 Pediatric Trials
  • 3. E8 General Considerations for Clinical Trials
  • 4. E6(R2)/E6(R3) Good Clinical Practice
  • 5. E9 Statistical Principles
- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals
- International standards
  • 1. Declaration of Helsinki
Data Management and Informatics17%- Data quality control
  • 1. Data validation and cleaning
  • 2. Query management and resolution
- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
- Data collection
  • 1. Electronic data capture systems
  • 2. Case report form design and completion
Professionalism and Ethical Practice15%- Continuous improvement
  • 1. Professional development and education
  • 2. Quality assurance and process improvement
- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
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
Ethical and Participant Safety Considerations19%- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- 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. Continuity of medical care
  • 3. Standard of care vs protocol requirements
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. Protocol development and amendments
  • 3. Study population and eligibility criteria

ACRP Certified Professional Sample Questions:

1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Approved by the IRB/IEC.
B) Under the supervision of the PI.
C) An employee of the institution.
D) Licensed to practice medicine.


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

A) To show superiority over another treatment
B) To demonstrate or confirm therapeutic benefit
C) To establish dose information
D) To establish the safety profile


3. 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.


4. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A) A signed clinical trial agreement between the site and sponsor is in place.
B) The site receives approval from the medical monitor to begin enrolling.
C) The DSMB meets and the first DSMB meeting report has been issued.
D) The CRA has performed source document review and verification at the site.


5. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Sponsor
C) Health authority
D) Investigator


Solutions:

Question # 1
Answer: B
Question # 2
Answer: B
Question # 3
Answer: B
Question # 4
Answer: A
Question # 5
Answer: B

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