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.
- 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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Employees of MCC member organizations are invited to join the MCC Trial Master File LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.