Course Description

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.

Watch the Course Trailer:



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.

Subject Matter Expert:
Danielle Giroud

50 min

Related resources:

Case studies:

Basic Account: € 152.00
Premium Account: € 114.00

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