Course Description

This web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate/Monitor will be explored.

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Learning Objectives

• Describe the regulatory purpose of monitoring device studies
• Define the basic types of monitoring visits and documentation requirements
• Explore the roles and responsibilities of the Clinical Research Associate (Monitor) for the various types of visits
• Discuss the meaning of protocol and regulatory (GCP) compliance
• Recognize the rationale behind adequate documentation of monitoring including identification of issues, corrective and preventive action and evaluation of effectiveness for issues (both site and sponsor)

Who Should Attend

• Clinical Research Associates
• Project Managers
• Personnel responsible for monitoring or managing medical device trials

Instructor

Marla Hoelle, B.S.N., R.N., C.C.R.A., ACRP-PM., P.M.P.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.