This one-day course provides an excellent introduction to clinical research for entry level CRAs. New and aspiring clinical research associates will be introduced to regulations, best practices, and their roles and responsibilities within a clinical trial.
Recall FDA regulations and Good Clinical Practices
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
Recall the elements of the FAIR ShakeTM Method, apply the method to potential compliance concerns, and understand the importance of supporting recommendations with the FAIR ShakeTM Method.
Identify best practices and skills to be an effective monitor
AGENDA: 8:30 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 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
Monitoring Visits Overview:
Visit Types: Site Assessment Visits, Site Initiation Visits, Periodic Site Visits, and Close Out Visits
Visit Preparation, Conduct, Documentation, and Follow-up
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
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
Aspiring Clinical Research Associates
New Clinical Research Associates with limited experience
