Topic: New FDA Draft Guidance – A Risk-Based Approach to Monitoring of Clinical Investigations
Date: May 14, 2019
Time: 1:00 p.m. – 2:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
The FDA released a draft Question and Answer guidance supporting and clarifying the finalized guidance on risk-based monitoring. Major areas it covers are how to plan your monitoring approach, developing your monitoring plan, and communication of results.
Join our own Sandra “SAM” Sather for this interactive training session on a risk-based approach to monitoring. Learn how the FDA draft guidance affects you.
Key take away benefits:
Understand what elements should be included in your monitoring plan for a risk-based monitoring approach
Learn how to apply risk management to developing a monitoring plan responsive to site performance
Recognize key activities for an effective site communication plan
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- The Clinical Pathways Team
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