Protocol Risk Assessment and Designing Site Quality Risk Indicators

Within this webinar, we will:

- Illustrate the process of using the outputs of protocol risk assessment to identify protocol risk indicators
- Illustrate the process of designing protocol risk indicators
- Explore the characteristics of good indicators of site quality risk
- Explore the practical application of surrogate risk indicators in RBM

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The webinar will take place on Thu, Sep 17, 2015

11:00 AM – 12:00 PM EST

4:00 PM – 5:00 PM BST

In 2013, regulatory authorities provided guidance that oversight and monitoring of clinical trials should take into consideration the risks associated with the protocol- in particular, critical processes and data.

Since then, there have been multiple publications on risk assessment and site quality risk indicators, but the 2 processes often remain distinct from one another.

This presentation will walk you through the process of taking outputs of the protocol risk assessment to designing specific measurements or risk indicators, to identify site quality risks. The process considers common risk indicators across studies, therapy/indication indicators and protocol specific indicators.

Presenter: Tammy Finnigan, COO for Triumph and TRI

Tammy’s entire career has been focused on clinical research, having worked in project management and clinical operations for 10 years, with both large Pharma and CRO businesses prior to joining Triumph in 2007. Tammy is the product sponsor for TRI’s risk-based monitoring platform and services, OPRA, and head facilitator for the Metrics Champion Consortium’s Risk-Based Monitoring Working Group.