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.
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
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
Foundation Package:
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
Monitoring Overview
Maintaining the Sponsor TMF
One Day Agenda: 8:30am – 4:30pm
Monitoring Best Practices
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
