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Last Updated: Aug 12, 2026

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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. Professional development and education
  • 2. Quality assurance and process improvement
Topic 2: Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E11 Pediatric Trials
  • 2. E8 General Considerations for Clinical Trials
  • 3. E6(R2)/E6(R3) Good Clinical Practice
  • 4. E9 Statistical Principles
  • 5. E2A Expedited Reporting
- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals
Topic 3: Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
- Study planning
  • 1. Study population and eligibility criteria
  • 2. Protocol development and amendments
  • 3. Sample size and statistical considerations
Topic 4: Clinical Study Operations15%- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
- Site management
  • 1. Study documentation and record keeping
  • 2. Site personnel training and delegation
Topic 5: Ethical and Participant Safety Considerations19%- 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
- Ethical principles
  • 1. Clinical equipoise and therapeutic misconception
  • 2. Human subject protections and privacy
- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
Topic 6: Data Management and Informatics17%- 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
- Data quality control
  • 1. Query management and resolution
  • 2. Data validation and cleaning

ACRP Certified Professional Sample Questions:

1. At a close-out visit, which document should be retained only at the site?

A) Treatment allocation
B) IP accountability
C) Subject identification code list
D) Final trial close-out monitoring report


2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) A monitoring report that identifies deviation from the approved protocol.
D) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.


3. The composition of an IDMC/DSMB should include which one of the following?

A) A sponsor representative who is knowledgeable about the study's unblinded information
B) A member from the IRB/IEC
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A lead PI for the study


4. SAEs must be reported immediately by the site to the:

A) IRB/IEC.
B) DSMB/IDMC.
C) Regulatory agency.
D) Sponsor.


5. 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) Sponsor
B) CRO
C) CRC
D) PI


Solutions:

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

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