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MCC: Improving Inspection Readiness -Trial Master File Basic Metrics

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© Metrics Champion Consortium 2018 6 Improving Inspection Readiness – TMF Basic Metrics to establish an understanding of when artifacts are expected during the study, so you can determine whether 10% is a 'good' or 'bad' result. In addition to understanding the expectations of what needs to be filed and when to expect it to be filed, defining artifact-level and TMF-level quality expectations are important for assessing quality as these expectations are used to generate different metrics. To address this challenge, the MCC created the MCC TMF Artifacts Mapping Tool to provide consortium members with a standardized means of establishing the additional expectations needed to support MCC metrics. Measure Against the Expectations Once you have established the expectations listed in the previous section, you have the foundation on which to build your metric system. Performance metrics are different from tracking metrics that only provide a listing of activities (e.g. number of artifacts filed in the TMF in Q2). You need to compare tracking metrics against an expectation or performance target to know whether the result is "good" or "bad." Looking at the metric example from the previous section, once you have milestone-based filing expectations, you can modify the metric to measure against the milestone expectation – comparing what is in the TMF against what you expected to have in the TMF at the milestone. It is easier to interpret these types of metrics as they align with the 100% scale in an intuitive way. As you recheck the TMF at study milestones throughout the study, you realign the expectations (the expected number and types of artifacts increases). Basic and Advanced Metric Sets When the TMF Work Group was launched, members decided to focus on metrics that can be used for the paper and basic eTMF model as shown in the TMF Metric Framework. [Figure 1] Since MCC has member organizations of varying sizes (ranging from very small to very large) as well as organizations that are in the process of adopting eTMF systems, we started by defining a basic metric set. These are the metrics we would expect most organizations to be measuring at a minimum. Advanced metrics are those that are for a deeper dive and to help determine root cause of process deviations. The advanced metrics are described in the companion White Paper "Improving Inspection Readiness – TMF Advanced Metrics." The advanced metrics relate to the process of using placeholders in an eTMF system. 4

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