eCOA Process Metrics v3.0 will be released at the Metric Demo and Q&A Meeting on April 27

Posted in Metrics

The MCC eCOA Process Metrics Work Group (now part of WCG AQC) – comprised of more than 200 individuals representing over 40 organizations – worked collaboratively from September 2020 to December 2021 to develop the assets contained in the eCOA Process Metrics Toolkit v3.0. The decision to review and update the eCOA metric toolkit was based on the following three considerations:

  1. Industry and regulatory trends such as increased patient engagement (ICH E8 R1), FDA Guidance on Patient-Focused Drug Development, and the move to an increased use of ePRO (electronic Patient Reported Outcomes) as part of implementation of approaches to decentralized clinical trials needed to be considered.
  2. Consortium members identified gaps in the metric set – in particular around translation, eCOA helpdesk, and training processes – areas not covered in detail in earlier versions.
  3. The eCOA Process Metrics Toolkit v2.0 was developed prior to consortium members discussing whether metrics included in metric toolkits should be designated as potential Key Risk Indicators to support Risk-Based Quality Management.

The work group followed the Metric Development Framework described in the White Paper: MCC’s Metric Development Framework: Defining Metrics That Answer Key Performance Questions [link] to develop the revised metric toolkit which includes 38 metrics that help users answer 31 key performance questions covering study start-up, conduct and close activities. Additionally, the group identifying 11 metrics as potential Key Risk Indicators to support Risk-Based Quality Management. The comprehensive metric toolkit includes an extensive overview guide and video tutorial, process maps, detailed metric definitions, and metric selection tools.

AQC Members are invited to participate in the launch meeting on April 27 at 10 am EDT to see the new metric toolkit and participate in a live Q&A session. Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.