The CRC for Beginners course provides clinical research professionals with basic training tailored to the CRC’s fundamental role in clinical trials. CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Coordinator (CRC)

Course Outline

• Introduction to Clinical Research. Main principles, history and future perspectives.
• Clinical Research Team
• Good Clinical Practice
• GDP
• HIPAA
• Phases of Clinical Trials
• Investigational Product (IP) Development.
• The Clinical Study Protocol and Study Feasibility
• Site Selection, and Study Initiation
• A consent form, IRB, and HIPAA
• Safety Reporting
• IP Accountability, Essential Documents, and Routine Monitoring Visits
• Source Document Verification, Data Management, and the Trial Close-out Visit
• Mock study review
• MockAudits & Inspections