The goal of the training is to provide a refresher on GCP and regulations governing medical device clinical research, as well as an energizing exploration of the importance of good monitoring and site management practices, methods for thinking strategically and critically, and industry trends and best practices. The theme of the training will be to highlight the importance of supporting site compliance, efficiency, timelines, enrollment, data quality, and ultimately, the approval of an investigational device.
DAY ONE 8:30 am - 4:30 pm
Good Clinical Practice and U.S. FDA Regulations Refresher
FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
Best Practices for Effective Monitoring and Site Management
Take Your Monitoring from GOOD to GREAT
High Quality Documentation and Maintaining the Sponsor TMF
Adverse Event Reporting for Medical Device Trials
Writing Excellent Reports
Treating Your Sites Like Customers
Follow-up and Follow Through: Effective Site Management
Debate Club: Notes-to-File, Delegation Logs, Consent Notes
Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites and Sponsors
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KNOWLEDGE LEVELS:
WHAT’S INCLUDED
