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.
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
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
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 Subject Protection: Drilling Down 21 CFR Part 50
Introduction to HIPAA and HITECH
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
In Person Training – At IMARC or Your Location
Hybrid training: web-based courses plus in-person training
12.0 hours (1.2 CEUs)
Beginner
Intermediate
