The use of eCOA methods to collect clinical trial data is rapidly expanding – especially during the COVID-19 pandemic. MCC members have requested that the consortium reconvene the eCOA Process Metrics Work Group to discuss possible updates to the metric set. The Work Group launched with an online public meeting where we reviewed the existing MCC eCOA metrics and discussed our focus for the upcoming review. The review will include updates to the process map and existing metric definitions. We will also explore new process metrics and which of the metrics could function as Key Risk Indicators as a part of Risk-based Quality Management (as required in ICH E6 R2). The revised toolkit will include the metric selection tools and implementation guide that is a part of all new and updated toolkits at the MCC.
Meeting Schedule
3rd Tuesday of the month, 11am – 12pm ET – Registration links are available on the Upcoming Meetings Webpage in the MCC Members Portal.
Team Output:
MCC eCOA Metric Toolkit v2.0
| Component | Purpose |
|---|---|
| At-A-Glance | Short document providing an overview of the MCC eCOA Metric Toolkit v2.0 |
| Webinars: 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.
Team Explored:
- 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.
Join Our LinkedIn Community
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.
