Curriculum
- 1 Section
- 6 Lessons
- 40 Hours
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- CONTENT:6
- 1.1Scientific Concepts and Research Design: Understand research methodologies, study designs, and the scientific principles underlying clinical trials.
- 1.2Ethical and Participant Safety Considerations: Learn about ethical standards, informed consent, and safeguarding participant welfare.
- 1.3Product Development and Regulation: Study the process of drug and device development, regulatory requirements, and compliance issues.
- 1.4Clinical Trial Operations (Good Clinical Practice): Gain knowledge of Good Clinical Practice (GCP) guidelines, trial management, and operational procedures.
- 1.5Study and Site Management: Explore site management tasks, including site selection, monitoring, and coordination.
- 1.6Data Management and Informatics: Understand data collection, management practices, and the use of informatics in clinical research.
Requirements
- Experience Requirement: 3,000 hours of professional experience in clinical research.
- Experience Substitution Options:
- Clinical Research Certifications: Holders of current ACRP-CO, CCRA, or CPI designations can substitute 1,500 hours of required experience.
- Clinical Research Education Programs: Completion of an accredited clinical research degree program can substitute 1,500 hours of required experience.
- Code of Ethics: Must agree to abide by the ACRP Code of Ethics and Professional Conduct.
Target audiences
- Clinical Research Coordinators
- Clinical Research Professionals
- Healthcare Professionals in research settings
- Individuals seeking certification in clinical research