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CLINICAL RESEARCH TRAINING

Clinical Research Associates: Comprehensive Training

COURSE DESCRIPTION:

This course provides an in-depth overview of the role of the Clinical Research Associate (CRA) in monitoring medical device studies. This course is ideal to onboard your new CRAs/Monitors, as well as for experienced CRAs transitioning from drug studies to device studies.

LEARNING OBJECTIVES:

  • Discuss FDA regulations and Good Clinical Practices and identify differences between drug and device clinical studies

  • Describe the different types of Monitoring Visits and responsibilities of monitors, including preparation, conduct,

    documentation, and site management

  • Describe definitions related to safety management, identification of adverse events, and reporting requirements

  • Identify best practices for effective monitoring and critical thinking skills for clinical researchers

  • Understand the mechanics of FDA inspections and describe at least three (3) recommendations to help sites and sponsors be inspection ready

COURSE OUTLINE

DAY ONE: 8:30 am – 4:30pm
  • 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 Parts 312, 812, 50, 56, 54, and 11

    • 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

  • The FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Key Roles and Responsibilities in Clinical Research: CRA Focused

  • High Quality Documentation and Maintaining the Sponsor TMF

 

DAY TWO: 8:30 am – 4:30pm

  • Site Selection and Initiation Visits

  • Monitoring Visits

    • Site Visit Preparation and Monitoring Tools

    • Periodic Site Visits: Regulatory Review, Consent Review, Source Data Verification, Product Accountability

  • Adverse Event Classification and Reporting

  • Post Visit Documentation

 

DAY THREE: 8:30 – 4:30pm

  • Follow-up and Follow Through: Effective Site Management

  • Study Close-Out

  • Monitoring Best Practices

    • Taking Your Monitoring From GOOD to GREAT

    • Treating Your Sites Like Customers

    • Writing Excellent Reports

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

  • Day In the Life of an Effective Clinical Research Associate: Best Practices

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

    • High Quality Documentation and Maintaining the Sponsor TMF

 

TYPE

  • In Person Training – At IMARC or Your Location
  • Hybrid training: web-based courses plus in-person training
     
CONTINUING EDUCATION CONTACT HOURS (CEUs)
21.0 hours (2.1 CEUs)

KNOWLEDGE LEVELS:

  • Beginner
  • Intermediate

WHAT’S INCLUDED

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

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

Monitoring Overview

Maintaining the Sponsor TMF

 

One Day Agenda: 8:30am – 4:30pm

Monitoring Best Practices

  • Taking Your Monitoring From GOOD to GREAT
  • Treating Your Sites Like Customers
  • Writing Excellent Reports

Follow-up and Follow Through: Effective Site Management

Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites and Sponsors

Day In the Life of an Effective Clinical Research Associate: Best Practices

  • Adverse Event Classification and Reporting

  • Investigational Product Accountability

  • High Quality Documentation and Maintaining the

    Sponsor TMF

IMARC University Courses, or Live Web Conferences(s)

  • Site Selection and Initiation Visits

  • Monitoring Visits

    • Site Visit Preparation and Monitoring Tools

    • Periodic Site Visits: Regulatory Review, Consent

      Review, Source Data Verification, Product Accountability

  • Adverse Event Classification and Reporting
  • Post Visit Documentation
  • Study Close-Out

Training Solutions For These Roles

  • New Clinical Research Associates with limited or no experience monitoring medical device studies
  • Experienced CRAs beginning to monitor device studies
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REGISTER FOR ONLINE TRAINING SERVICES