New Approaches to SAE Reconciliation for Paper and EDC Studies: A Collaborative Perspective

1. New Approaches to SAE Reconciliation for Paper and EDC Studies: A Collaborative Perspective PSDM Meeting 22-May-2008 Weesp, The Netherlands Shannon Labout, CCDM Senior Consultant

2. New Approaches to SAE Reconciliation: Outline • Introduction • Background • Example project • Collaboration Opportunities (discussion points)

3. Background • Six Sigma methodology - DMAIC • Define – process improvement goals / defects • Measure – how many? what does each one cost? • Analyze – how will making an improvement reduce defects/costs? • Improve - implement the improvement • Control – control the defects so they don’t occur

4. Project Background • Project Assumptions and Scope • Use existing technologies • Limit project to evaluate • SAE collection / reporting process • SAE data query process • Process for delivering safety data to statisticians

5. What is our Current Approach? • Collect SAEs using parallel processes - clinical and safety • Separate entry process • Separate data collection forms • Separate query process • Reconciliation process is required • Differences between databases • Potentially different responses to queries

6. Current Approach to SAE Reconciliation CDM Query Process CDM SOPs Site records event Event entered Into Clinical database Serious? Record on CRF Clinical data No Yes Report to Sponsor Within specified Reporting period Safety Query Process Event entered Into Safety database Expedited Reporting Safety SOPs

7. Current Approach: Problems • SAE Reconciliation must be done as a separate process • Two databases with the same data • Duplicate queries may be sent to the site • Two organizations managing the same data • Safety – for PV and reporting • Clinical – for analysis and submission

8. Current Approach: Problems • SOPs not aligned between clinical and safety • They work in “silos” • May not even know what the other group is doing • Site is confused and frustrated • Queries from two groups on same data

9. Current Approach: Problems • Possible for events to be unreported in one system • Potential need for query responses to be reconciled • Time is lost managing duplicate processes and then cleaning up the mess • Costs are higher than they need to be

10. Current Approach to SAE Reconciliation CDM Query Process CDM SOPs Site records event Event entered Into Clinical database Serious? Record on CRF Clinical data No Yes Report to Sponsor Within specified Reporting period complex duplicate work Safety Query Process Event entered Into Safety database Expedited Reporting not aligned Safety SOPs

11. Project Plan • Identified that we have a problem • What exactly is causing the problem, though? • How do we fix it? • Need to gather some data and analyze • Methodology chosen: DMAIC

12. Project – Define/Measure/Analyze/Improve/Control • Defect • An SAE term that must be manually reconciled • Clearly defined • Measurable operational defect • Includes all reconciliation activities (including data entry verification)

13. Project – Define/Measure/Analyze/Improve/Control • How many defects (SAEs)? • We can count them • We can put a cost to each one • 1000 SAEs per year • 60 minutes to reconcile each one • Data entry verification • Query management • Database reconciliation • $5/minute to do this work

14. Project – Define/Measure/Analyze/Improve/Control • Determine the cost to the organization • N*T*C = cost to the organization • N = Number of defects • T = Time to reconcile each defect • C = Cost per time unit • 1000 * 60 * 5 = $300,000 / year • What can we change that will improve this?

15. Current Approach to SAE Reconciliation CDM Query Process CDM SOPs Site records event Event entered Into Clinical database Serious? Record on CRF Clinical data No Yes Report to Sponsor Within specified Reporting period WHY are we entering this data twice? Safety Query Process Event entered Into Safety database Expedited Reporting Safety SOPs

16. Project – Define/Measure/Analyze/Improve/Control • Decision to simplify the process • Single data collection process • Eliminates duplicate query process • What would the results be • Number of defects potentially reduced • Time to reconcile reduced (data entry verification, simple verification, query resolution) to 15 minutes per SAE • Single query process (data only queried once)

17. Project – Define/Measure/Analyze/Improve/Control • How much improvement? • N*T*C = cost to the organization • 1000 * 15 * 5 = $75,000 • $300,000 - $75,000 = $225,000 saved each yearEven if the number of defects remains the same

18. Project – Define/Measure/Analyze/Improve/Control • Align SOPs and WPGs between clinical and safety • Monitor the process with audits and documentation • TRAINING!

19. New Approach: Solutions • Enter data into only one system • Databases do not have to be reconciled with each other • Safety manages SAE queries, clinical all others • No duplicate queries are sent to the site • Time is gained by managing a single query process • Site has only one query process to deal with • Reduces site frustration and confusion

20. New Approach: Solutions • SOPs aligned between clinical and safety • Collaboration • Cooperation • Communication • Shared responsibility • High Quality – Lower ongoing costs – Better Timelines

21. Current Approach to SAE Reconciliation Site records event Serious? CDM SOPs simplified aligned Yes Safety SOPs Report to Sponsor Within specified Reporting period Clinical data Safety Query Process Event entered Into Safety database Expedited Reporting

22. Discussion PointsOther Opportunities for Collaboration • Process mapping – find what is necessary, what is not: • Align processes across other internal groups • Different regulatory requirements –must meet all needs • Different organizational goals • PV – safety for all drug products • Clinical – analysis and submission data • Clinical – site, science, patient safety, informed consent • Shared training / cross training • Build understanding • Build cooperation • New technologies / EDC and eSource

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