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ACRP-CP pdf
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 11, 2026
  • Q & A: 127 Questions and Answers
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  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 11, 2026
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  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
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. Continuity of medical care
  • 2. Informed consent development and review
  • 3. Standard of care vs protocol requirements
Data Management and Informatics17%- Data quality control
  • 1. Query management and resolution
  • 2. Data validation and cleaning
- Data collection
  • 1. Electronic data capture systems
  • 2. Case report form design and completion
- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
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
Clinical Study Operations15%- Site management
  • 1. Study documentation and record keeping
  • 2. Site personnel training and delegation
- Project management
  • 1. Timeline and budget management
  • 2. Vendor and stakeholder management
Study Design and Conduct17%- Study implementation
  • 1. Site selection and activation
  • 2. Investigational product management
  • 3. Study monitoring and oversight
- Study planning
  • 1. Protocol development and amendments
  • 2. Sample size and statistical considerations
  • 3. Study population and eligibility criteria
Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E9 Statistical Principles
  • 2. E8 General Considerations for Clinical Trials
  • 3. E11 Pediatric Trials
  • 4. E2A Expedited Reporting
  • 5. E6(R2)/E6(R3) Good Clinical Practice
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki

ACRP Certified Professional Sample Questions:

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

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


2. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Blinding
B) Placebo-controlled
C) Randomization
D) Privacy controls


3. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Clinical Monitoring Plan
C) Data & Safety Monitoring Plan
D) Standard Operating Procedure


4. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Report
B) Investigator Brochure
C) Clinical Study Protocol
D) IDMC/DSMB Report


5. Which of the following elements of the Informed Consent are NOT required?

A) A description of potential benefits
B) Subject legal rights can be waived
C) A description of any reasonably foreseeable risks or discomforts
D) Statement that study involves research


Solutions:

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

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