Trial Master File Performance Metrics Work Group

Meeting Schedule

4th Thursday of the month, 10-11am EST Registration links available on Upcoming Meetings Webpage in MCC Members Portal

Team 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.

Team Output:

    Trial Master File Work Group output so far to date:

  • 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) *tool reissued January 2018 to include suggested milestones/events by which artifacts should be included in the TMF
  • 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

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 Trial Master File White Paper

View webinar on MCC TMF Basic Metric Toolkit

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