CLINICAL RESEARCH TRAINING

COURSE DESCRIPTION:

LEARNING OBJECTIVES:

• Recognize regulatory pathways for medical devices
• Discuss how to comply with the requisites of Good Clinical Practice (GCP)
• Explore the practical day to day activities of conducting a medical device trial under GCP

COURSE OUTLINE

AGENDA: 8:00 am - 5:00 pm

• Introduction to Good Clinical Practice: ICH GCP Guidelines
• Understanding Medical Device Regulatory Requirements
  • 21CFR Parts 812, 50, 56, 54 and 11
  • INDs vs IDEs: Comparing 21 CFR Parts 312 vs. 812
• International Guidance for Medical Devices
  • ISO 14155: Overview of the Standard
  • 21 CFR 812 vs. ISO 14155: Key Differences
• Human Subject Protection
  • Drilling Down 21 CFR Part 50: Conducting and Documenting Proper Informed Consent
  • Protecting Subject Protected Health Information (PHI): HIPAA and HITECH
• FAIR Shake^TM Critical Thinking Method for Answering Challenging Research Questions
• Key Roles and Responsibilities in Clinical Research Overview
  • Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager, and Statistician

• Day-to-Day Best Practices
  • Adverse Event Classification and Reporting
  • Investigational Device Accountability
  • High Quality Documentation and Maintaining the Sponsor TMF

ADDITIONAL WEB-BASED COURSE ADD-ONS

• History of Clinical Research
• Critical Thinking in Clinical Research
• Monitoring Overview
• FDA Inspectional Findings