Mini Workshop

Identifying Common Risk Factors to Support Tiering Sites for Monitoring

Wednesday, September 29, 2021, 9:45 AM - 11:15 AM

All sites are not created equal, does this matter?

With the increasing number clinical trials being conducted, and the need to expand the number of sites getting involved in research; there is general recognition that a ‘one size-fits all’ approach to site monitoring is not fit for purpose.

ICH E6 (R2) RBQM framework supports tailoring monitoring approaches to the specific risks of the study and the pending update to ICH E8 (R1) also points to recognizing sites as stakeholders in the study design and how communicating study risks to sites may support a more collaborative approach to study conduct.

This workshop aims to evaluate if site tiering is a viable option for providing a better fit for purpose monitoring approach.

We will consider common risk factors related to experience and past performance that could be used to create site tiers and explore the possibility of using the outcomes of the study risk assessment to engage the site in evaluating how these risks may impact them, and how this could be used as an input into the monitoring tier.

This workshop will also evaluate the factors that could be used to adjust a site’s monitoring tier throughout the study.

Faculty: