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With so many sponsors and CROs focused on finding the right technology solution for implementing risk based monitoring, a key element often gets overlooked—the risk assessment. For a clinical research program and protocol, a comprehensive risk assessment is essential to ensuring your risk based strategy is a success.
Here’s why: to appropriately define a risk based strategy, you must identify the key data, define the appropriate performance thresholds, and determine the appropriate monitoring levels for a specific protocol. To do this adequately, you must first identify the risk factors unique to the investigational product, the program and the protocol.
However, understanding the risks of the trial only solves part of the equation. The missing link is understanding the risks of each individual site. No trial is exempt from the challenges of an underperforming site. With a comprehensive risk assessment that focuses on site risk factors, a sponsor can set each site up for success by defining a focused risk mitigation strategy.
A risk assessment that includes the evaluation of each site will add a number of benefits, including: 1) Improving site selection by stratifying sites based on key risk factors; 2) Establishing early mitigation plans for sites with higher risk; 3) Determining a site-specific monitoring level (prior to the study start) that is based on actual data; and 4) Assigning monitors and site managers appropriately, based on site risk.
At Blueprint, we help clients implement our risk assessment methodology for risk based monitoring strategies as well as for optimizing site selection in traditionally monitored clinical trials. The Blueprint Clinical methodology looks at site risks in an objective and logical way that is easily communicated throughout the clinical trial organization with concise visualizations and reporting.