MCC Risk Assessment & Mitigation Management Tool Redesigned to Align with ICH E6 (R2) Section 5.0

Thursday, September 20, 2018

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.