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MCC Case Study: Lilly-Quintiles ECG Metrics

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8 Eli Lilly and Quintiles Case Study: Using MCC ECG Performance Metrics to Improve Sponsor, Site, and Core Lab Clinical Trial Operations Results: Quality Improvements Through Review of Metrics Example 3: Percentage of ECG Queries from Vendor to Site Definition Formula/Example Unit of Measure Reporting Frequency Target Minimum: The number of queries generated between the core lab and the site, compared to the number of ECGs received for a sponsor and core laboratory Formula: (Total N of queries generated between the core laboratory and the site ÷ Total N of ECGs received) x 100 Total N and Percentage (%) Quarterly <20% Review Steps Studies 7 & 8: Both studies are Oncology studies; Traditionally, oncology study sites have not • previously focused on the ECG/Cardiac safety component of clinical studies High number of queries related to the system generating multiple queries when a single ECG has • missing, inconsistent, or unexpected information. We need to better define how to handle this metric as some vendors will report multiple queries on a single ECG while others would indicate that if an ECG has multiple queries on it, it is only counted as one Action Plan Lilly and Quintiles will review the study data by site to determine which sites need to be retrained • in order to submit ECGs with complete information – thus reducing the query workload for the sites and Quintiles Lilly will review results to identify how effective different site training methodologies (in person • vs web conference vs taped training) are to determine the best option. This analysis was completed and it showed that with over 1.5 years of data the data does not suggest that the type of site training had any impact on the reliability of the site to complete the demographic information appropriately Study 6 Study 8 Study 7 TARGET ABOVE BELOW Study 1 Study 2 Study 3 Study 4 Study 5 Study 10 Study 9 Average JUNE 2007

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