2nd Tuesday of the month, 10-11am EST Registration links available on Upcoming Meetings Webpage in MCC Members Portal
Team is Exploring:
- The impact of ICH E6 (R2) on Data Management and Biostatistics metrics.
- Data Management and Biostatistics metrics developed previously by the MCC and any updates / modifications needed.
- The opportunity to measure new metrics using data from separate systems that industry members are now able to consider due to system integrations.
- 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.
- Data Management and Biostatistics Work Group output so far to date:
- Data Management and Biostatistics process map showing the metrics
- Definitions of key terms
- Critical Success Factors and Key Performance Questions
- A Basic metrics set
- An Advanced metrics set
- Guidance on implementation
Looking for additional information?
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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
Download MCC Data Management and Biostatistics White Paper
View webinar on MCC Data Management and Biostatistics Work Group Progress Webinar
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Employees of MCC member organizations are invited to join MCC Data Management and Biostatistics LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.