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CLINICAL RESEARCH TRAINING

Clinical Research Coordinator: Comprehensive Training

COURSE DESCRIPTION:

This course provides in-depth training of the roles and responsibilities of the clinical research coordinator (CRC) participating in medical device studies. This course is ideal to onboard new CRCs, as well as for experienced CRCs transitioning from drug studies to device studies.

LEARNING OBJECTIVES:

  • Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCPs)

  • Recognize critical elements of human subject protection, safety reporting requirements, and good documentation

  • Review the different types of Monitoring visits and understand what to expect and how to work well with your monitor

  • Identify best practices and skills to be an effective research coordinator

  • Understand how to prepare your site for FDA BIMO inspections and sponsor audits

COURSE OUTLINE

DAY ONE 8:00 am - 4:30 pm

  • The History of Clinical Research

  • Introduction to Good Clinical Practice: ICH GCP Guidelines

  • Introduction to the U.S. FDA Regulations for Clinical Research

    • 21 CFR Part 312, 812, 50, 56, 54, and 111

    • INDs vs IDEs: Comparing 21 CFR Parts 312 and 812

  • 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

  • High Quality Documentation and Study Records

    • Source Documentation

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

  • Day in The Life of an Effective Clinical Research Coordinator: Best Practices

DAY TWO: 8:30 am - 3:30 pm

  • Monitoring Visits: Hosting and Follow-up

  • Site Selection and Initiation Visits

  • Study Close-Out and Beyond

  • Conducting and Documenting Informed Consent: Best Practices

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

  • Corrective and Preventative Action Plans: Identifying, Documenting, and Implementing to Improve Site Compliance

  • Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites


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

  • Day in The Life of an Effective Clinical Research Coordinator: Best Practices

  • Monitoring Visits: Hosting and Follow-up

  • Site Selection and Initiation Visits

  • Study Close-Out and Beyond

  • High Quality Documentation and Study Records

    • Source Documentation

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

  • Conducting and Documenting Informed Consent: Best Practices

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

  • Corrective and Preventative Action Plans: Identifying, Documenting, and Implementing to Improve Site Compliance

  • Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites

Training Solutions For These Roles

  • Clinical Research Coordinators with limited experience in managing clinical trials
  • Experienced Coordinators seeking to enhance or refresh their skills to more effectively and efficiently manage studies

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


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion
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