Work Groups

Each MCC metric set and scoring tool is developed through structured discussions in collaborative work groups. MCC staff and subject matter experts work with a Leadership Team, comprised of a select group of MCC member representatives, to develop draft versions of initiative deliverables that are vetted and further refined by a broader group of member representatives in the work group. Member organizations are encouraged to have representatives participate in all MCC work groups in order to share experiences and learn about metric practices of other member organizations. MCC work group meetings are not recorded at the request of member organizations.

Work group expectations:

  • One hour web-based meetings, once every month
  • Attend and actively participate in most meetings
  • Anticipate approximate 12 month duration
  • Frequent requests to complete structured reviews and provide feedback outside of meetings (assignments typically require 15-30 minutes to complete)

Active Work Groups


Work GroupDeliverablesFrequency
Cardiac Safety
Monitor use of metrics, modify as needed

Central Lab
Monitor use of metrics, modify as needed
1st Tuesday of the month, 10-11am ET
Centralized Monitoring
-Data analytic basics webinar and white paper
-Centralized monitoring models
-Central Monitoring Plan template
-Quality tolerance limits
3rd Wednesday of the Month
Clinical Operations
Impact of ICH E6 (R2) on metrics:
-Updates to existing MCC metrics
-New MCC metrics
TBD – new group
Clinical Supply
Develop basic/advanced metric set
TBD – new group
Data Management and BiostatisticsImpact of ICH E6 (R2) on metrics:
-Updates to existing MCC metrics
-New MCC metrics (e.g. focusing on missing data and critical data)
-White Paper and Webinar available
2nd Tuesday of the Month
eCOAMonitor use of metrics and modify as needed
4th Tuesday of the Month
Imaging -A newly revised set of imaging metrics that accommodates current industry practices, technologies and regulatory requirements
-High-level process maps showing imaging vendor oversight metrics
-Critical Success Factors and Key Performance Indicators
-Guidance on implementation
-Recommendations for further exploration and development
3rd Tuesday of the Month
Phase 1Consolidated list of high priority metrics to be used in Phase I studies – utilizing existing MCC metrics and additional metrics, if needed.


Site Selection and Start-UpSite scorecards - to be confirmed
2nd Thursday of the Month
Small/Mid-sized Sponsor Community of Practice-Quality management system template forms
-Summary updates on other MCC initiatives
-Vendor oversight scorecards
4th Tuesday of the Month
Study Quality Trailblazer -Cost of Poor Quality Estimator Tool
-Protocol Operational Complexity Tool
-Cloud-based RACT tool with MCC Risk Assessment & Mitigation Management (RA&MMT) components
-Risk-based QM - ICH E6 (R2) expert webinars
-Change management webinar and worksheet
-Quality Management Capability Maturity Model
2nd Wednesday of the Month
TMF Work Group-MCC TMF Basic Metrics Toolkit
-MCC TMF Advanced Metrics Toolkit
-6 basic metrics defined-webinar available
-Case study on implementation of the MCC TMF Basic Metrics in an eTMF
3rd Tuesday of the Month
Vendor OversightImpact of ICH E6 (R2) on vendor oversight and metrics:
-Time, quality and efficiency metrics for measuring CRO performance
-Relationship metrics (survey based) for assessing the Sponsor-CRO relationship
-Different approaches to aggregating data across studies
-White paper available
1st Wednesday of the Month

Retired Work Groups

Future Work Groups