The MCC eCOA Work Group developed the MCC eCOA Metrics v2.0 after reviewing survey feedback and hearing perspectives from Sponsors, CRO and eCOA Providers. Updates to the metric set include the new MCC metric numbering system, separating Program and Study metrics into two distinct metrics, an Implementation Guide and clarification and modifications to some metric definitions and terms.
At October’s Implementation Q&A meeting, the attendees recommended changes to the metric set following the discussion. The updates now being considered are to metrics 4a and 4b to clarify the use of shipment date rather than receipt date for measuring whether equipment is available on time. In addition, we agreed to review the targets for all the metrics and look to revise them to the red-yellow-green format. There was also a discussion about which of the metrics could potentially be used as Key Risk indicators as part of Risk-Based Quality Management. The MCC will be drafting proposed updates for review by member organizations. We will then meet again to discuss the feedback, agree on the changes and publish the updated eCOA Metrics Toolkit.
The proposed updates will be available for members to review by the end of November. Those in member organizations who have indicated an interest in eCOA metrics will receive notification of their availability and request for review and feedback. It is anticipated that the updated eCOA metrics toolkit will be launched early in 2020.
MCC eCOA Metric Toolkit v2.0
|At-A-Glance||Short document providing an overview of the MCC eCOA Metric Toolkit v2.0|
MCC eCOA Basics Webinar
MCC eCOA Metric Toolkit v2.0 Updates
Provides an overview of eCOA Metrics
Provides an overview of the Toolkit updates
|Process Maps||Provides a listing of the metrics shown on a high-level process map|
|Metrics Workbook||Contains metric definitions, purpose, recommended usage, target, glossary and process map|
|Metric Implementation Support Tools:|
|Metric Implementation Guide||Provides guidance on how to implement and use the MCC eCOA metrics|
|Implementation Points to Consider||Outlines key considerations and best practices in the implementation of the MCC eCOA metrics|
MCC member organizations can download the MCC eCOA Metric Toolkit v2.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.
- Current electronic Clinical Outcomes Assessment (eCOA) approaches and regulatory expectations
- How process maps help to define and visualize eCOA processes during study start-up, conduct and close-out
- Establishing a set of standardized MCC eCOA performance metrics similar to the MCC Cardiopulmonary metric sets
MCC Membership Information
This is a member-only group. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland or call 317-622-0266. Contact Linda Sullivan to discuss additional study team-related details. Return to Work Group List
MCC eCOA Metric Toolkit v2.0*
- Toolkit At-A-Glance
- eCOA Basics Recorded Webinar
- Toolkit Updates Recorded Webinar
- Process Maps
- Metrics Workbook
Metric Implementation Support Tools:
- Metric Implementation Guide
- Implementation Points to Consider
*Available to MCC Member Organizations. For more information on membership options contact Membership Director Terry Holland.
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Employees of MCC member organizations are invited to join the MCC eCOA LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.