MCC: Improving Inspection Readiness -Trial Master File Basic Metrics

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© Metrics Champion Consortium 2018 5 Improving Inspection Readiness – TMF Basic Metrics Performance Metrics - Primer The T-M-F mnemonic provides a reminder about the importance of establishing robust process and performance expectations against which to measure actual performance, and then to fix any problems that the measurements uncover. Measurements should continue to be used to determine whether the problems are truly fixed, and to monitor in case other problems arise. This is another way of looking at the well-known Plan-Do-Check-Act cycle, an iterative four-step management method for the control and continual improvement of processes and products. Taking time to establish expectations is the "Plan" part of the cycle. The act of building up the TMF by processing and filing artifacts is the "Do" part of the cycle. Measuring whether artifacts are being filed according to the timeline and the quality standard is the "Check" part of the cycle. Fixing any problems that are uncovered by the measurement is the "Act" part of the cycle. Take Time to Establish Expectations Before any measurements of the TMF process or outcomes can be made, you must establish some important expectations: • What should be filed in the TMF? • Where should artifacts be filed? • When should artifacts be filed? • Who is responsible for filing the artifacts? • What document/artifact- and TMF-level quality requirements must be met? Most organizations utilize the TMF Reference Model as a starting place to determine what to include in the TMF, how to organize the TMF content and whether artifacts are sponsor/site level. Additionally, the TMF Reference Model provides some quality criteria, too. This approach provides you the means of establishing many of the expectations you need to generate performance metrics. However, as the MCC TMF Metrics Work Group began to explore the types of performance questions and metrics people need to answer those questions, we recognized the importance of building on the TMF Reference Model to establish expectations at folder level in order to establish the expectations needed to generate meaningful metrics. The following example illustrates why the missing requirements are important. If you conduct an assessment check of the TMF at the end of study start-up and determine that 10% of artifacts that are expected to be in the TMF by the end of the study are currently in the TMF – what does that tell you? You need

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