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.

This audio conference covers:

• A comprehensive review of key monitoring mandates required during interim-type monitoring visits
• Compliance requirements and corrective action plans, and follow-up to the corrective action plans of findings noted during an interim monitoring encounter
• Proper organization of key deliverables to help meet trial objectives
• Understanding the communication pathways available to identify and resolve significant and non-significant findings during an interim monitoring contact
• Tasks and documentation required to meet a prospective investigative site or sponsor site regulatory body inspection

About the speaker:

JoAnn Tyson is CEO and Senior Clinical and Regulatory Affairs Director at J. Tyson & Associates, a full-service CRO. Her expertise covers most facets of clinical research, including audits, training, monitoring, data management, site management, site selection, budget and contract management/negotiation, medical writing, SOP development and management, pre-audit training, investigator meeting planning and organization. Her specialities include Phase I-IV, pharmaceutical, medical device, IVD and vaccines. Since starting JTA in 1993, JoAnn has been involved with more than 60 clinical trials. She is an RN with a Masters prepared in Health Care Administration and has spent more than 25 years in the field of pharmaceuticals, medical devices, IVDs and vaccines.

Who should attend?

• CRAs, CRCs, and PI
• Proctors
• Quality Assurances
• Clinical Device Personnel
• Regulatory Associates
• Project Managers
• Clinical Data Associates
• Clinical Research Assistants