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CLINICAL RESEARCH TRAINING

Good Clinical Practice: An Introduction to Medical Device Research

COURSE DESCRIPTION:

This course provides an overview of medical device clinical trial activities and applicable Good Clinical Practices including, FDA 21 CFR 812: IDEs, ISO 14155, ICH GCP E6 Guideline and E6(R2) Addendum. The information presented is ideal for those new to clinical research or those new to medical device industry requiring understanding relating to the regulatory and practical aspects of medical device clinical research.

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 ShakeTM 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

TYPE

  •  In Person Training – At IMARC or Your Location
 
CONTINUING EDUCATION CONTACT HOURS (CEUs)
8.0 hours (0.8 CEUs)

KNOWLEDGE LEVELS:

  • Beginner
  • Intermediate

WHAT’S INCLUDED

  •  Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References (Whitepapers and Infographics) 
  • Certificate of Completion

ADDITIONAL WEB-BASED COURSE ADD-ONS

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

Training Solutions For These Roles

  • Clinical Research Associates, Project Managers, or clinical trial staff wanting a greater understanding of regulatory and daily activities around medical device clinical trials
  • Clinical research staff new to the device industry and clinical trials
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