Course Description

In the current GCP regulatory climate, risk-based decision-making should be supported within the clinical Quality System. A management approach used in many industries where performance is critical under tight timelines for regulated activities, risk-based decision-making makes sense for such activities as sponsor monitoring in clinical research. Applying a risk-based approach to the monitoring and site management should be based on a given project’s risk profile. A risk-based approach can address current monitoring practices that are costly and ineffective, and help projects meet financial and compliance goals. This web seminar will present the concepts and case scenarios of risk-based monitoring (RBM).

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Learning Objectives

• Recognize where risk-based decision-making fits into the clinical quality system
• Identify risks for a project related to monitoring
• Identify components to include in building the project profile risk score
• Apply risk factors to various study decisions, i.e., monitoring plan, site assignments, and frequency

Who Should Attend

• Site Research Managers
• Clinical Research Associates/Monitors
• Study/Clinical Research Associate Managers
• Sponsors/CROs

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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