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

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