Risk-based Monitoring And Targeted SDV

This course will assess the practicalities of implementing a risk-based approach and will demonstrate how risk based monitoring can contribute to better oversight of your clinical studies.

Employing the most efficient strategies for monitoring is crucial to reducing the risks and costs associated with your clinical trial - it is estimated that sponsors can save 23% of trial costs with a risk-based approach.

The course will take an in-depth look at the requirements for risk-based monitoring and targeted Source Data Verification (SDV) including which factors influence the scope of on-site SDV vs. remote SDV. Monitoring aspects will be assessed based on a standard risk assessment for investigational sites and how it can be applied.