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Updated: Aug 08, 2026

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

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

A) Sponsor
B) Investigator
C) Monitor
D) Coordinator


2. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This needs to be reported to the patient's primary care physician.
B) This needs to be reported to the regulatory authorities within 10 business days.
C) This qualifies for expedited reporting to the sponsor.
D) This qualifies for prompt reporting to the IRB/IEC within 15 business days.


3. The IB contains which of the following sections?

A) Known pharmacokinetic effects
B) Participant dosing schedule
C) IP preparation instructions
D) Participant eligibility criteria


4. A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A) Phase I
B) Phase II
C) Phase III
D) Phase IV


5. What would a sponsor use to implement and maintain quality in a study?

A) Statistical analysis plan
B) Clinical trial agreement
C) Protocol signature pages
D) Standard operating procedures


Solutions:

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

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