Working 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.
Working 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.
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