A Key Risk Indicator (KRI) Definition Process

Hopefully you have a sense of what KRIs are, but if not check out this post. Now let's look at a potential process for defining, tracking and handling KRIs for your studies:

A (Simple!) KRI Process

1. Follow a KRI process that is fed by the risk management process.

   1. Risks should be defined per study, as well as revisited and updated throughout the study -see the risk assessment post.

   2. KRIs should be defined based on the agreed risk statements from your risk assessment.

      
      

2. Develop an organized, searchable database of KRIs.

   1. To simplify locating them, ideally these are linked to the risk statements.

   2. Include key information about the KRI: use cases, historical experience and outcomes, links or screenshots to outputs...

      
      

3. Specify KRIs for your study.

   1. Identifying KRIs should be kicked off via a cross-functional study team meeting.

   2. Start with CtQ factors, expand to other important aspects of quality as identified in the QbD process.

   3. Have a champion to drive discussion, utilizing study design elements and question prompts to help the team brainstorm. See the KRI post for ideas.

   4. Leverage your risk database with relevant KRIs to help identify relevant ones.

   5. Ideally document them in your study Risk Management Plan (RMP). See this post covering risk assessment including KRIs in the RMP.

      
      

4. Implement your KRIs: notifications, reports, dashboards...

   1. Configure based on the KRI requirements in your RMP.

   2. Test the outputs to ensure they are delivered to specification, including intended owners. Document the testing.

   3. Consider this as part of your study startup or implementation process.

      
      

5. Revisit KRIs through periodic risk review meetings.

   1. Per the RMP ensure there is an owner that will manage updates to the KRIs.

   2. KRIs thresholds may need to be revised if the existing threshold has been met.

   3. If changes to the output are needed, retest as appropriate.

Key Risk Indicators should be a central component to your study delivery strategy and are critical to successful Risk-Based Quality Management. Define, document and implement KRIs as part of your study risk management process.

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