ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 15, 2026
  • Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Professionalism and Ethical Practice15%- Professional standards
  • 1. Role responsibilities and boundaries
  • 2. Confidentiality and conflict of interest
- Continuous improvement
  • 1. Quality assurance and process improvement
  • 2. Professional development and education
Topic 2: Regulatory and Compliance Requirements17%- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals
- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E9 Statistical Principles
  • 2. E6(R2)/E6(R3) Good Clinical Practice
  • 3. E2A Expedited Reporting
  • 4. E8 General Considerations for Clinical Trials
  • 5. E11 Pediatric Trials
Topic 3: Study Design and Conduct17%- Study implementation
  • 1. Investigational product management
  • 2. Site selection and activation
  • 3. Study monitoring and oversight
- Study planning
  • 1. Protocol development and amendments
  • 2. Sample size and statistical considerations
  • 3. Study population and eligibility criteria
Topic 4: Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
- 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. Informed consent development and review
  • 3. Standard of care vs protocol requirements
Topic 5: Clinical Study Operations15%- Site management
  • 1. Study documentation and record keeping
  • 2. Site personnel training and delegation
- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
Topic 6: Data Management and Informatics17%- Data reporting
  • 1. Database lock and data transfer
  • 2. Data integrity and security
- Data collection
  • 1. Electronic data capture systems
  • 2. Case report form design and completion
- Data quality control
  • 1. Data validation and cleaning
  • 2. Query management and resolution

ACRP Certified Professional Sample Questions:

1. A study protocol must contain which of the following elements?

A) Participant reimbursement details
B) Data management plan
C) Description of statistical methods
D) Chemical structure of the IP


2. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

A) CRO
B) CRC
C) Sponsor
D) PI


3. 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) Health authority
C) Investigator
D) Sponsor


4. A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A) Decline the study.
B) Recruit for the study without use of social media.
C) Rely on the sponsor to notify the IRB/IEC.
D) Use a central IRB/IEC.


5. Which of the following reports should be retained in participant charts?

A) Safety reports
B) Lab reports
C) DSMB/IDMC reports
D) IRB/IEC progress reports


Solutions:

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

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