Trial Master File Performance Metrics Work Group

Work group is exploring:

  • How well the TMF process is being executed and managed throughout a study’s start-up, conduct and closeout.
  • How well the TMF process is being performed across studies.
  • Criteria that defines an “acceptable level” of performance.
  • Establishing a “basic” metric set that can be used in paper and/or eTMF programs and a more “advanced” metric set that can be adopted by organizations with more advanced eTMF systems and experience using TMF metrics. 

Work Group output will include:

  • TMF Process Map
  • TMF Wiki – Key Terms and Definitions
  • TMF Metric Practices Industry Survey Results
  • TMF Artifacts Mapping Tool (based on TMF Reference Model v3)
  • TMF Critical Success Factors & Key Performance Questions
  • MCC TMF “Basic” metric sets (paper and eTMF) and “Advanced” metric set (eTMF). MCC will focus on developing the basic set(s) before expanding into the advanced set.
  • TMF Assessment Tool to track assessment and calculate key metrics

For additional information, please view recent news blogs:

Announcing New TMF Metric Toolkit that Improves Inspection Readiness

MCC eTMF/TMF Metrics Leadership Team Progress Webinar

TMF Survey – Are You Measuring the Same Metrics as Your Peers?

MCC members are invited to visit the Existing Metric Sets section of the MCC Member Portal to view all of the TMF Basic Toolkit materials.

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

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