Continuing Education Credits and Certificate Program units are not available for Archived Webinars.
The pharmaceutical research industry is abuzz with the idea of risk-based monitoring. Very few companies have implemented risk-based monitoring into their clinical trials; as many sponsors and CROs feel that risk-based monitoring is too risky. They know that the traditional way of monitoring trials with 100% source document verifi cation on a routine 4-8 week monitoring frequency is expensive, but it feels safe. It’s the way they’ve always run their trials, and it’s the way they can confidently show the FDA they are appropriately overseeing their studies.
This webinar examined the FDA Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, August 2011, from the regulatory, sponsor and CRO viewpoints and discussed how the Guidance can improve risk-based monitoring and therefore overall clinical trial management. We looked closely into the guidance document to see there is no “risk” in risk-based monitoring. It clearly provides the fundamentals in how to approach and organize monitoring plans in a way to better achieve protocol compliance, patient safety, and ensure date integrity for our critical data endpoints. We also looked at potential procedures in a risk-based monitoring plan, such as the use of an EDC System and centralized monitoring; subject safety risk assessments; identification of critical study data points; and, methods for ongoing evaluation of site performance.
Who Should Attend
Professionals involved in:
- Clinical Research
- Clinical Safety/Pharmacovigilance
At the conclusion of this webinar, participants should be able to:
- Discuss how to determine when a clinical research study requires, and how to develop a common sense risk-based monitoring plan
- Describe potential procedures in a risk-based monitoring plan
- Explain the Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, August 2011, and determine if there is no “risk” in risk-based monitoring
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