MCC Data Management and Biostatistics Work Group

Purpose:

MCC Data Management and Biostatistics Work Group members are working in a collaborative environment to review the Data Management and Biostatistics metrics in the MCC Clinical Trial Performance Metrics v1.2.

Work Group 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.

Work Group output will include:

  • 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

Work Group meetings:

Monthly meetings 2nd Tuesday of the month

Open space to share thoughts and ideas with your industry colleagues – be a thought leader!

For additional information about joining this Working Group, please contact Customer Service (customerservice@metricschampion.org)

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