One of the challenges in meeting the ICH E6 (R2) guidelines involves managing risk. While this is an area that Sponsors are already well familiar with, and typically have established plans for, the new addendum spells out some particular changes. One example is the way that risk needs to be addressed by Sponsors in conjunction with their vendor partners. As well, the addendum calls out the need to apply technology to the previous paper processes of clinical trial management; the area of risk management is not immune to this directive.

Summary of FDA’s Risk Management Guidelines

In a previous Comprehend webinar, a number of Risk Management Best Practices were defined in order to meet the guidelines proposed by this addendum. These Best Practices were described as being able to align the FDA risk management guidelines with four elements on which Sponsors can focus to put the guidelines into play. In summary, the FDA calls out the following key areas: