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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Continuity of medical care
  • 3. Informed consent development and review
- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
Clinical Study Operations15%- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
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
Study Design and Conduct17%- Study planning
  • 1. Sample size and statistical considerations
  • 2. Study population and eligibility criteria
  • 3. Protocol development and amendments
- Study implementation
  • 1. Site selection and activation
  • 2. Investigational product management
  • 3. Study monitoring and oversight
Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E11 Pediatric Trials
  • 2. E9 Statistical Principles
  • 3. E2A Expedited Reporting
  • 4. E6(R2)/E6(R3) Good Clinical Practice
  • 5. E8 General Considerations for Clinical Trials
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki
Data Management and Informatics17%- 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
- Data reporting
  • 1. Database lock and data transfer
  • 2. Data integrity and security

ACRP Certified Professional Sample Questions:

1. 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) Randomization
B) Placebo-controlled
C) Privacy controls
D) Blinding


2. The coding system for a double-blind clinical trial is accessible by the:

A) Regulatory authority
B) Sponsor
C) IRB/IEC
D) PI


3. When designing a clinical trial, why is it important to define the study population?

A) To support the study objectives
B) To support subject recruitment to the study
C) To determine the study objectives
D) To determine where to conduct the study


4. After the site qualification visit report has been finalized, it must be:

A) Sent to the IRB/IEC for review and approval.
B) Stored in the sponsor's budgets and contracts file.
C) Included in the PI's regulatory file.
D) Kept in the CRO/sponsor's trial master file.


5. Which strategy is used to safeguard subject privacy?

A) Utilize subject initials on correspondence.
B) Email updated enrollment logs to the CRA.
C) Store source documentation in the CRC's office.
D) Conduct subject-related conversations in controlled environments.


Solutions:

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

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