MCC’s QbD – RBQM – Quality Improvement Community of Practice Group is a multi-stakeholder, virtual community of practitioners who meet on a regular basis to share experiences, discuss challenges and develop solutions.
Members of the MCC QbD-RBQM-Quality Improvement Community of Practice are focused on establishing and implementing performance metrics and procedures in their organizations that produce high quality protocols, better identify and reduce risks before the start of a study, and better oversee risks during the study. This member-only collaborative group is supported by the broader MCC community of MCC Ambassadors, Solution Providers and MCC staff. Team members help one another blaze a trail by establishing a new pathway to clinical study quality.
Bimonthly on the 2nd Wednesday of the month, 11am – 12pm ET. Registration links available on Upcoming Meetings Webpage in MCC Members Portal
Team is Exploring:
- The tool(s) available to help manage protocol and risk assessments.
- Quality and Risk Management with the implementation of ICH E6 (R2).
- Evidence on the challenges of study complexity, quality and cost.
- Measuring the cost of quality (investment and return) and the cost of non-quality (cost of amendments, preventable issues).
- Measuring operational complexity of a protocol – from the perspective of the study, site and subjects.
- How to gain buy-in for implementing organizational changes that emphasize study quality over study start dates.
- Metrics to help determine whether the pre-startup investment has yielded studies of higher quality.
QbD – RBQM – Quality Improvement CoP Output:
- Risk Assessment & Mitigation Management Tool (v2.0) released 9/2018
- Cost of Poor Quality Estimator Tool (v0.2) released 8/2017
- Protocol Operational Complexity Tool (v1.0) released 12/2017
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
Join Our LinkedIn Community
Employees of MCC member organizations are invited to join the MCC QbD-RBQM-Quality Improvement LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.