Course Description

Although monitoring plans are not defined or specifically required by FDA regulations, the FDA endorses the use of this tool in a Quality Systems management approach to clinical research. The traditional approach to monitoring plan development has relied upon reinforcing SOP-mandated monitoring activities with little focus on project and/or protocol-specific monitoring needs. This web seminar provides participants with concepts and templates to establish a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance.

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Learning Objectives

• Identify the contents of a monitoring plan including affiliated monitoring procedural documents, tools
• Develop a monitoring plan to meet the unique needs of a project and protocol
• Determine the triggers for revisions to monitoring plans and the importance of version control
• Explain FDA recommendations for risk-based monitoring plans
• Describe the relationship of the monitoring plan to the CRA for monitoring and managing site performance, meeting project goals and promoting continuous improvement

Who Should Attend

• Clinical Research Associates
• Project Managers
• Clinical Research Associate Managers

Instructor

Marla Hoelle, R.N., B.S.N., C.C.R.A.-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.