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MCC: Improving Inspection Readiness -Trial Master File Basic Metrics

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© Metrics Champion Consortium 2018 15 Improving Inspection Readiness – TMF Basic Metrics Putting It Together: MCC TMF Metric Toolkit The four pieces come together to provide a comprehensive set of tools to measure and help manage the TMF. The MCC TMF Basic Metric Toolkit includes these four pieces as well as the MCC TMF Implementation Scenario. The Scenario describes how a Sponsor and CRO worked together to implement the TMF Basic Metric set. Take Time to Establish Expectations TMF Reference Model This is the publicly available standard for the structure and contents of the TMF. This is managed and maintained outside the MCC. MCC TMF Artifacts Mapping Tool The MCC TMF Artifacts Mapping Tool builds upon the TMF Reference Model to establish study-, country- and site-level TMF expectations at an increased level of granularity necessary to generate meaningful metrics. The mapping tool enables organizations to establish milestone- and event-based TMF filing expectations against which to measure

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