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MCC: eCOA Metrics At-A-Glance

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For additional information about the MCC, please visit www.metricschampion.org MCC eCOA Metrics v1.0 At - A - Glance MCC eCOA Metrics Version 1.0 At - A - Glance In early 2015, Metrics Champion Consortium (MCC) member organizations - sponsors and electronic Clinical Outcome Assessment (eCOA) vendors - requested that the MCC facilitate the development of a standard set of eCOA performance metrics to include in the growing MCC library of clinical metric sets. They believed that the time was right to establish an initial set of measures since the use of eCOA ( COAs include patient, clinician, and observer reported outcomes ) h as continued to grow and evolve. This growth is partially due to it being one of several tools that help support the current emphasis on patient - centered clinical research. In re sponse, MCC launched the eCOA Performance Metrics Initiative to define a stan dardized set of eCOA performance metrics to be used by clinical trial sponsors, CROs and eCOA vendors to assess the timeliness, quality and effectiveness of the eCOA setup and data collection services. Utilization of these metrics will enable organization s to understand how well the process is being executed and managed throughout study start - up, conduct and closeout. During the first phase of metric development process, MCC worked exclusively with the eCOA Leadership Team - comprised of representatives f rom ten member organizations ( sponsors, eCOA vendors, CROs) – to establish the foundation on which to build the metric set . The Leadership team followed the MCC Metric Development Framework to guide the development process (see Figure 1). Specifically, the y created an MCC eCOA Metrics Process Map , define d nine eCOA Critical Success Factors (CSFs) and draft ed 28 Key Performance Questions (KPQs). In the final phase of the metric development process, an expanded MCC - member working group re fine d the deliverab les and produced a set of metrics that answer s the KPQs. MCC Metrics Champion Consortium ©2015&Metrics&Champion&Consor5um,&All&rights&reserved& Measure'What'Matters'Most'–'Metrics'That'Influence'Behavior' MCC'METRIC'DEVELOPMENT'FRAMEWORK' 9& MCC Metrics Champion Consortium Define&Cri5cal& Success& Factors&(CSFs)& Define&Key& Performance& Ques5on&(KPQ)& Define&&& Measure&Metric& to&Answer&KPQ& Generate&Metric& Display&that& Answers&KPQ& Format'display'to'highlight'answer(s)' Define&&& Measure&Metric& to&Answer&KPQ& Generate&Metric& Display&that& Answers&KPQ& Define&Key& Performance& Ques5on&(KPQ)& Define&&& Measure&Metric& to&Answer&KPQ& Generate&Metric& Display&that& Answers&KPQ& Develop& Process&Map& Copyright 2016, Metrics Champion Consortium, LLC Figure 1: MCC Metric Development Framework

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