Course Description

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

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Learning Objectives

• Discuss BIMO Sponsor/CROs and monitors program
• Identify components of a sponsor monitoring system: Beyond SOPs
• Distinguish each component’s suggested elements
• Define adequate oversight of non-employee performers
• Identify other measures to ensure quality monitoring
• Evaluate gaps in monitoring systems

Who Should Attend

• Sponsor Senior Management
• Project Managers
• Clinical Research Associate Managers
• Quality Assurance and Compliance Professionals
• Clinical Research Associates

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.P.H.

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