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ACRP ACRP-CP Exam Syllabus Topics:
Section
Objectives
Clinical Trial Operations
- Study start-up activities
1. Protocol implementation
2. Site preparation
- Study conduct
1. Participant management
2. Safety reporting
Ethical and Participant Safety Considerations
- Regulatory compliance
1. IRB and ethics requirements
2. ICH GCP adherence
- Human subject protection
1. Informed consent
2. Participant rights
Data Management and Documentation
- Data integrity
1. Query resolution
2. Data collection
- Clinical trial documentation
1. Essential documents
2. Source documentation
Professional Responsibilities
- Leadership and professionalism
1. Professional ethics
2. Decision making
- Communication and collaboration
1. Stakeholder communication
2. Cross-functional teamwork
Quality Management
- Risk management
1. Quality assurance
2. Corrective and preventive actions
- Audit and inspection readiness
1. Compliance monitoring
2. Inspection preparation
ACRP Certified Professional Sample Questions:
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
A. Recording the date and time each data element is entered onto the source document.
B. Allowing real-time access for data review in the eCRF.
C. Recording data on source documents at the time the data are collected during the conduct of the study.
D. Comparing source document data to other data recorded in the same study time period.
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:
A. One member who is independent of the institution/trial site.
B. One member whose primary area of interest is in the same scientific area.
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