Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans

is being presented by JoAnn Tyson, CEO & Senior Clinical and Regulatory Affairs Director, with J. Tyson & Associates and airs on Wednesday, February 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com

Monitoring for a medical device trial can present unique challenges related to the complexity of the protocol, data capture tools, site personnel selection and limited oversight of subjects/data or procedures inconsistent with good clinical practices (GCP). However, proper monitoring can allow the sponsor/CRO to identify risks more readily and more clearly.

This audio conference presentation focuses on best practices for monitoring medical device trials, from the essential areas of focus during interim site visits to the proper training of monitors and other clinical personnel to ensure trial objectives are achieved. Our speaker also discusses compliance requirements and corrective action plans, and reviews the necessary steps in preparing for a successful regulatory body inspection.