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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: 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. Study population and eligibility criteria
  • 3. Sample size and statistical considerations
Topic 2: 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
Topic 3: Data Management and Informatics17%- Data quality control
  • 1. Data validation and cleaning
  • 2. Query management and resolution
- Data reporting
  • 1. Database lock and data transfer
  • 2. Data integrity and security
- Data collection
  • 1. Case report form design and completion
  • 2. Electronic data capture systems
Topic 4: Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals
- ICH Guidelines
  • 1. E8 General Considerations for Clinical Trials
  • 2. E11 Pediatric Trials
  • 3. E9 Statistical Principles
  • 4. E2A Expedited Reporting
  • 5. E6(R2)/E6(R3) Good Clinical Practice
Topic 5: 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 6: Ethical and Participant Safety Considerations19%- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Informed consent development and review
  • 3. Continuity of medical care

ACRP Certified Professional Sample Questions:

1. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

A) Sponsor
B) CRA
C) PI
D) CRC


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

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


3. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Information to be included in the advertising flyer
B) Location of stored trial records
C) Length of time to receive the approved trial device
D) Availability of qualified staff to conduct the trial


4. Which statement does NOT represent a study monitor's responsibilities?

A) Provide communication between the sponsor and the PI.
B) Verify that the PI has adequate qualifications and resources to conduct the study.
C) Report serious adverse events to the IRB/IEC.
D) Check the accuracy and completeness of case report forms with source documents.


5. Which document confirms the PI's agreement to permit auditing at the study site?

A) Delegation Log
B) Protocol
C) IB
D) ICF


Solutions:

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

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