Closing in on an Initial set of CAPA Metrics

Monday, December 21, 2015

The Metrics Champion Consortium (MCC) is launching a Metrics Development Working Group to define a standardized set of CAPA performance metrics to be used by clinical trial sponsors and CROs to assess the timeliness, quality and effectiveness of the CAPA process. Utilization of these metrics will enable organizations to understand how well their CAPA process is being executed.

In 2015, the MCC formed a CAPA Leadership Team comprised of eight MCC member organizations; both sponsors and CROs. They made use of the MCC Metrics Development Process to develop a CAPA Process Map, define five CAPA Critical Success Factors (CSFs), list six Key Performance Questions (KPQs), and draft six metrics that align with the KPQs. They also drafted definitions for nine common CAPA terms. The MCC is now conducting a brief survey designed to gather feedback from MCC Member organizations about the draft set of CAPA metrics.

If you are a MCC member and wish to participate in the guided review of the CAPA metrics, log onto the MCC Member Portal to see the list of open surveys which includes, MCC CAPA Draft Metrics Set – Member Feedback 2015-2016. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC CAPA Working Group that will make recommendations on the initial set of CAPA metrics. You can signup to be part of this working group at the end of the survey.

In addition to this survey, the MCC also has available the recording of a recent presentation on the CAPA Leadership Team’s results as well as an overview document on the status of the CAPA Metrics Development initiative. Both of these are available to members and can be found in the WG Resource Center section of the Clinical CAPA Workgroup page on the MCC Member Portal.

Please contact Linda Sullivan at for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.