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EDC Metrics: The Full Utilization of EDC Functionality

EDC Metrics: The Full Utilization of EDC Functionality. Teresa Ancukiewicz, CCDM Boston Scientific Corporation. December 7, 2007. Metrics: EDC vs. Paper. The main concept of data review and trend analysis is similar, but: Traditional roles, processes have changed

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EDC Metrics: The Full Utilization of EDC Functionality

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  1. EDC Metrics: The Full Utilization of EDC Functionality Teresa Ancukiewicz, CCDM Boston Scientific Corporation December 7, 2007

  2. Metrics: EDC vs. Paper The main concept of data review and trend analysis is similar, but: • Traditional roles, processes have changed • Data cleaning effort is refocused • EDC metrics should derive benefits from EDC functionality

  3. EDC Environment • More rapid availability of study data in the EDC database • Project team can make decisions earlier • Enforce compliance • Track Protocol Deviations • Detect safety concerns • Amend protocols as needed

  4. EDC Environment – cont. New areas for CDM to measure: • Queries answered, not closed • Forms/patients not Source Verified • Forms not signed • Forms partially completed • Forms/patients reviewed • Safety review

  5. Developing EDC metrics • Specify early: • tie to eCRF design • understand functionality • may require changes to reporting environment • help define reporting requirements for other functions • brings team together early

  6. Same Metrics, Different Meaning • CRF locked: • paper studies: usually done by Database group, more final • EDC: done by CDM, can be easily unlocked and re-locked, review-tracking tool • Time from Visit to Data Entry • paper: indicator of site, CRA, CDM performance • EDC: indicator of site performance only • Audit Trail report: • paper: CDM data entry activities • EDC: site data entry activities

  7. EDC Specific Metrics • Modules pending PI review and signature • Average time from query issued to query answered (site performance) • Average time from query answered to query closed (CRA, CDM, Safety performance)

  8. EDC Specific Metrics – cont. • Time from Data Entry to SDV (CRA efficiency) • Time from Visit to Data Entry (site performance): gaining or losing the benefit of immediate access to data

  9. EDC Specific Metrics – cont.

  10. Shaping the Process Depending on the process…. discover inefficiencies: • Queries answered, but not closed • process in place for closing? • presence at the site needed to close? • who can close?

  11. Core CDM Metrics • Initiative to come up with a comprehensive list of all CDM reports, across all platforms • Sent to Clinical for review, input • Narrow to the most essential metrics to start with

  12. Essential CDM Metrics

  13. Essential CDM Metrics

  14. Query Rate per Patient – EDC vs. Paper

  15. Query Rate EDC vs. Paper Why higher on EDC studies? • No self-evident corrections • Frequent saving – queries will fire • Partial data available and entered • New system – learning for CDM and sites • More re-queries: sites answer queries, but do not change data points

  16. Challenges for Cross-Functional Cooperation • Clear specifications • Agreement on meaningful metrics • Who runs and reviews • Duplicate metrics requests • Established path to request reports • Who programs reports

  17. The Goal • One set of essential metrics • Roll out across the organization in Clinical Trials • Reduce one-off requests, confusion • Have a library of programmed metric reports • Impact on resourcing • Streamline the CDM and project team approach to the study data • Compare across studies • Establish expectations

  18. Summary • Fully utilize what EDC can offer • Harmonize approach to reviewing data • Improve processes • Tie to standard CRF design • Collaboration with key Clinical functions is essential

  19. Thank You! Teresa Ancukiewicz, CCDM Senior Manager Boston Scientific Corporation ancukiet@bsci.com

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