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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E8 General Considerations for Clinical Trials
  • 2. E6(R2)/E6(R3) Good Clinical Practice
  • 3. E9 Statistical Principles
  • 4. E11 Pediatric Trials
  • 5. E2A Expedited Reporting
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki
Topic 2: Professionalism and Ethical Practice15%- Continuous improvement
  • 1. Quality assurance and process improvement
  • 2. Professional development and education
- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
Topic 3: 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. Query management and resolution
  • 2. Data validation and cleaning
Topic 4: Clinical Study Operations15%- Project management
  • 1. Timeline and budget management
  • 2. Vendor and stakeholder management
- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
Topic 5: Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- 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 6: Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Site selection and activation
  • 3. Investigational product management
- 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. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) IB
B) Package insert
C) Protocol
D) ICF


2. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Identify critical processes and data during protocol development.
B) Perform a periodic review to see if the quality methods are effective and relevant.
C) Train the research coordinator on the required study assessments schedule.
D) Determine the quality tolerance limits for data transcription errors.


3. Which of the following is a conflict of interest for a PI conducting a study?

A) A PI who is a key opinion leader, writes the protocol
B) A PI who receives payment for the study
C) A PI that votes on the IRB/IEC approval of the protocol
D) A PI that presents at an investigator meeting


4. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The PI should amend the medical chart.
B) The PI should notify the monitor.
C) The CRC should write a note to file.
D) The CRC should amend the medical chart.


5. The inclusion and exclusion criteria are in place so all subjects are:

A) Healthy and willing to complete the clinical trial.
B) Ethically vulnerable and patients with the disease under study.
C) Medically appropriate and protected from ethical vulnerability.
D) Patients with the disease under study and will not have any adverse events.


Solutions:

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

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