Members of the MCC Study Quality Trailblazer Team 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. We collaboratively develop solutions to the challenges that members voiced in the poll at the launch of the Work Group (see white paper).
2nd Wednesday of the month, 10-11am EST 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.
- Study Quality Trailblazer Work Group output so far to date:
- Reviewed Tufts data on the challenge
- Reviewed tools such as ProDevST, RA&MMT and the initiative planning tool
- Seen a cloud-based RA&MMT demonstrated
- Quality Management Capability Maturity Model (Duncan Hall, TRI)
- ICH-E6(R2) – Regulators View of Risk-based Quality Management (Ann Meeker-O’Connell, J&J)
- Pfizer’s Quality Journey (Jonathan Rowe)
- Change Management (Chaucer Life Sciences)
- 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