Meeting Schedule:
2nd Wednesday of the month, 10-11am EST
Registration links available on Upcoming Meetings Webpage in MCC Members Portal
The Metrics Champion Consortium (MCC) is leading an initiative for change. The MCC Study Quality Trailblazer Team (a Risk and Quality Management Support Group) will help member organizations who are interested in working with other members to set an example for the rest of the industry by demonstrating that investing time and resources up front can yield higher quality clinical study performance at a lower cost than fixing quality issues during the study.
Members of the MCC Study Quality Trailblazer Team will focus 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 will be supported by the broader MCC community of MCC Ambassadors, Solution Providers and MCC staff. Team members will help one another blaze a trail by establishing a new pathway to clinical study quality. We will also collaboratively develop solutions to the challenges that members voiced in a recent poll (see white paper).
Team is exploring:
- How to gain buy-in for implementing organizational changes that emphasize study quality over study start dates.
- Measuring the cost of quality (investment and return) and the cost of non-quality (cost of amendments, preventable issues).
- Planning for the use of protocol assessments (prior to final protocol) and study risk assessments (with time to reduce risks prior to study start).
- The qualifications and responsibilities to lead a study quality initiative.
- Selecting the right roles to participate in protocol and risk assessments.
- Choosing the right study(s) to pilot the initiative.
- The tool(s) available to help manage protocol and risk assessments.
- Creating oversight across portfolios of protocols to look for trends.
- Metrics to help determine whether the pre-startup investment has yielded studies of “higher quality”.
Meeting topics:
- Quantifying the Cost of Poor Quality [Feb 2017]
- Update on ICH GCP and its Renovation- A.Meeker-O’Connell (Former FDA Director) [Jan 2017]
- Pfizer Quality Improvement Journey- J.Rowe [Dec 2016]
- QM Capability Maturity Model [Dec 2016]
- MCC Stage 1 QM Initiative Planning Workbook [Nov 2016]
- Demo: Cloud-based version of MCC RAMMT [Nov 2016]
- Organization-specific implementation plans
- Study Quality benchmarks / metrics
- Updated Risk Management Implementation Guide
- Public presentation of results
MCC members are invited to view meeting material available on the Study Quality Trailblazer Group webpage located in the MCC member portal.
Team output will include:
Looking for additional information?
MCC Initiating Study Quality Trailblazer Team Announcement
MCC Study Quality Trailblazer Team white paper
ICH GCP and its Renovation blog post
Register for the Group by Completing a Brief Questionnaire
To receive more information about the Trailblazer team, please complete a brief 3-minute questionnaire to help us gather study quality improvement implementation challenges that exist in organizations and to provide your contact information. [Complete the questionnaire].
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, ex.108.
ContactLinda Sullivan to discuss additional study team-related details.