The MCC Risk Assessment & Mitigation Management Tool (RA&MMT) v2.0 fully supports the risk-based approach to quality management, addresses gaps identified in version 1.0, identifies when a risk signal emerges and encourages critical thinking.
Developed by the MCC Study Quality Trailblazer Work Group and facilitated by MCC Ambassador Keith Dorricott, RA&MMT v2.0 has been modified to:
- Support critical data and process identification
- Update the definition of detectability to include the time aspect
- Pull information that is hidden through the tool into a Risk/Mitigation library
- Bring the terminology into line with the ICH E6 addendum including Quality Tolerance Limits
- Look at ways to encourage critical thinking rather than a checkbox approach
- Include rescoring functionality
RA&MMT v2.0 toolkit includes:
- At-a-Glance document providing an overview of the MCC RA&MMT v2.0
- Recorded webinar and slides that provides an introduction and background
- RA&MMT v2.0 tool ready for use
RA&MMT v2.0 Implementation tools include:
- MCC RA&MMT v2.0 instructions on how to use the tool – including screenshots
- Recorded webinar demonstration of the use of the tool
- Examples of the tool with sample data
MCC Member organizations can download the MCC Risk Assessment & Mitigation Management Tool (RA&MMT) v2.0 toolkit by visiting the MCC metrics sets and tool page.
Learn more about the MCC Study Quality Trailblazer Work Group.
Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.