Risk based monitoring (RBM) offers many advantages over the traditional approach of 100% source document verification. Plenty of sponsors and CROs can attest to this with facts, figures, and case studies. Regulators even encourage sponsors to utilize this approach. So it’s a no brainer right? Well it depends on your organization and the kinds of studies you are running.

In this forum we will explore the many facets associated with RBM and answer questions such as:

• What are the most significant pros and cons?
• Are there types of studies that RBM is more or less optimal for?
• How do I ensure I have selected the right CRO partner?
• What is the impact on costs and timelines?
• How do investigational sites feel about RBM?

Join the discussion with our experienced panel who will explore these and many other questions surrounding this approach to monitoring. The hope is that you will leave this discussion better prepared to determine the best path forward for your organization.

Sponsored by the Biostatistics, Data Management & Clinical Trials (BSDMCT) Forum Working Group.