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CLINICAL RESEARCH TRAINING

MEDICAL DEVICE CLINICAL RESEARCH: COMPREHENSIVE TRAINING

COURSE DESCRIPTION:

The goal of the training is to provide learners new to the device industry an introduction to regulations and responsibilities of investigational device studies by the FDA. Learners will review the key requirements of 21 CFR Part 812, identify similarities and differences with 21 CFR Part 312, and compare developmental pathways of new drugs and new devices. The training will additionally walk through other important differences in day to day of device and drug studies, such as site assessment, investigator training, monitoring, documentation and the trial master file.

LEARNING OBJECTIVES:

  • Identify applicable ICH GCP E6 R2 and ISO 14155 guidelines and FDA regulations governing medical device research
  • Understand the development pathways of new drugs vs new devices
  • Navigate through the requirements governing clinical research using critical thinking skills
  • Describe best practices for creating and maintaining high quality documentation in research at sites
  • Recall requirements and methods for maintaining a compliant trial master file

COURSE OUTLINE

DAY ONE 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

DAY TWO: 8:00 am - 1:30 pm

  • Developing Risk-Based Strategies for Device Studies

  • Securing Compliance in Device Studies: Effective Monitoring and Site Management

  • Safety Monitoring and Oversight: DSMBs, CECs and Medical Monitors

  • Building Quality into Device Studies

  • FDA’s BIMO Program: Inspection of Sponsors, CROs, and Monitors – “Preparing for Inspection Success from Day 1”


HYBRID AGENDA

 

IMARC University Courses

Foundation Package:

  • The History of Clinical Research

  • Introduction to Good Clinical Practice

  • Introduction to U.S. FDA Regulations

    • Introduction to U.S. FDA Regulations Part I: 21 CFR Parts 312 and 812

    • Introduction to U.S. FDA Regulations Part II: 21 CFR Parts 50, 56, 54 and 11

    • Comparing 21 CFR Part 312 and 21 CFR Part 812

  • Human Subjects Protection

    • Human Subject Protection: Drilling Down 21 CFR Part 50

    • Introduction to HIPAA and HITECH

  • The FAIR ShakeTM Method

  • Key Roles and Responsibilities in Clinical Research

    • Project Manager Overview

    • Monitor Overview

    • Primary Investigator Overview

    • Research Coordinator Overview

 

One Day Agenda: 8:00 – 5:00pm

  • International Guidance for Medical Devices

    • ISO 14155: Overview of the Standard

    • 21 CFR 812 vs. ISO 14155: Key Differences

  • Day to Day Best Practices

    • Adverse Event Classification and Reporting

    • Investigational Device Accountability

    • High Quality Documentation and Maintaining the

      Sponsor TMF

  • Developing Risk-Based Strategies for Device Studies

  • Securing Compliance in Device Studies: Effective

    Monitoring and Site Management 

Training Solutions For These Roles

  • Clinical Research Professionals experienced in drug trials but new to device industry
  • Clinical Research Associates, Clinical Research Coordinators, and Project Managers
  • Sponsor/CRO staff members new to the device industry

TYPE

In Person Training – At IMARC or Your Location
Hybrid training: web-based courses plus in-person training


CEUs

12.0 hours (1.2 CEUs)


KNOWLEDGE LEVELS:

Beginner
Intermediate
Experienced


WHAT’S INCLUDED

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