MCC Central Lab Performance metric members are working in a collaborative environment to review and update the process workflow document and associated metrics in the MCC Central Lab Metrics v2.1.
- Central Lab Work Group is exploring the following topics:
- The impact of ICH E6 (R2) on Central Lab workflow and metrics
- The impact of risk-based monitoring approaches on Central Lab workflow and data
- The Central Lab v2.1 metrics and associated workflow developed previously by the MCC and any updates / modifications needed
- Establishing a “basic” metric set that can be used by most organizations and a more “advanced” metric set that can be adopted by organizations with more advanced systems and experience using metrics.
- Central Lab Work Group output will include:
- Updated process flow diagram and metric set for Central Lab Performance Metrics
- Critical Success Factors and Key Performance Indicators
- Definitions of key terms
- A Basic metrics set
- An Advanced metrics set
- Guidance on implementation
Looking for additional information?
Those interested in joining the work group should log into their member account and select Central Lab Work Group in their user profile. For additional information about joining the Central Lab Work Group, please contact Customer Service at firstname.lastname@example.org.
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. Contact Linda Sullivan to discuss additional study-team related details. Return to Work Group List