Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach
Course Description:
The course provides an overview of onsite monitoring and discusses the regulations and standards that currently govern the monitoring practice. It also examines the FDA guidance on risk-based monitoring, discusses real-world applications of the guidance, and looks at the current monitoring climate.
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Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Define risk-based monitoring
- Implement risk-based monitoring approaches to clinical trial oversights
- Understand the FDA guidance “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring”
Who Should Enroll:
Clinical research professionals are encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.