1. Aaron Gadberry Director, Software Architecture Gathering and
Leveraging Quality- Centric Metadata in Clinical Trials
2. Increasing Initial Quality Quality data on the first pass
Problem personnel Historic performance Dynamic Risk Based
Monitoring Cost model adjustments 2
3. Lower Quality = Higher Cost Direct Cost More cleaning
Indirect Cost Treatments could be less effective Treatments could
be less safe 3 Data Entry Data Cleaning$$$ Clean Data $$$
4. Responsibility? Who is managing site quality today? Who is
reporting on Entry Personnel Who is holding them accountable CRAs
Site Audits What are the key metrics? 4
5. What Metrics Do We See? Completeness Page report Time to
Entry Time to SDV Time to Sign Time to Resolve Queries Quality
Query counts 5
6. What Metrics Dont We See? Was the initial data accurate? If
not, was intervention required? If so, how many interventions? What
trends are visible from this? How often is initial data accurate?
How often is a change self-initiated? 6
7. Difficult to Collect and Report On Applicable data takes
time to gather Hindered by turnover at sites Not preserved for the
next trial Visible as points, but not aggregated We need to predict
quality to realize the full benefits of Risk Based Monitoring
7
8. We Have a Wealth of History Leverage historic quality data
during site selection CTMS / Cloud Show quality over time
Cross-trial, cross-sponsor Rapid visibility Hotspot reports over
users 8
9. Number of Users by Data Quality 9
10. Volume of Data by Data Quality 10
11. With Quality Increased by 3% 11
12. With Quality Increased by 5% 12
13. With Quality Increased by 10% 13
14. Major Results from Minor Changes Increasing user initial
quality By 3% reduces data changes by 31% By 5% reduces data
changes by 48% By 10% reduces data changes by 79% 14
15. Application of the Tools Measuring makes us aware But we
cant really solve the problem Only the site can truly manage The
personnel are theirs Why isnt this happening today? Lack of
measurement, lack of incentive 15
16. We Can Change These Measurement New Metrics Incentive
Contract for quality For Sites and ClinOps Similar metrics for CRAs
16
17. The Value of Quality Performance and consistency gain value
beyond repeat business Additional Income Exposure Recruitment A
Market Emerges for Quality-Centric Sites and Personnel 17
18. The Market will Adapt We will pay more for quality data But
The overall cost is lower Data is more accurate Confirm and adjust
Dynamic Risk Based Monitoring Risk is user-based 18
19. A Quality-Centric Model Expectation to manage quality is
set Quality directly influences payment Performance impacts future
business Sites are motivated and compensated 19
20. from Concept to Cure with DATATRAK ONE DATATRAK
International Cleveland, Ohio Bryan, Texas Cary, North Carolina
888.677.DATA (3282) Toll Free www.datatrak.com