CTSA Improvements in Clinical Research Management Daniel Rosenblum CTSA Clinical Research Management...
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Transcript of CTSA Improvements in Clinical Research Management Daniel Rosenblum CTSA Clinical Research Management...
CTSA Improvements in Clinical Research Management
Daniel RosenblumCTSA Clinical Research Management Coordinator
Secretary’s Advisory Committee on Human Research Protections October 19, 2010
Protocol Approval-related Improvements in
Clinical Research Management at CTSA Sites
• IRB modifications with data to show effect– Reliance Harvard Catalyst (Barbara Bierer)– Common UC Davis (Eric Mah)– Regional Wisconsin (U Wisconsin – Madison) (Nichelle
Cobb)• Process stream modification “peri-IRB”– Yale (Tesheia Johnson)
What would constitute Protocol Approval-related “Improvements?”– Reduction in time to study start up?– Better quality?– Increased value, lower cost?
CTSA Steering Committee: Time is top priority– Goal: Reduce time significantly, Publish metrics– Current time: 1 – 2 years
Meaningful Improvement Requires• Preservation of processes that assure regulatory
compliance• Management of novel interventions, increasing
complexity, and undetermined risks• Provision of avenues for local expression of concern for
protection of subjects (“it’s not just the protocol”)• Development of published metrics that document
speedier start up, improved quality, and reasonable cost• Pursuit of the mission of developing an improved
academic home for clinical research
In Search of Process “Improvements”• Will improved “IRB” management speed study start up?
– IRB review time at CTSA sites• Data on IRB review still being analyzed, second protocol
– Alternative models (Harvard, UC Davis, Wisconsin)• Data on usage• Discussion of details• Evidence of reduction in time to study start up
• Will improvement in other factors speed study start up?– Process mapping/streamlining example (Yale)– Issues in process streamlining
• IRB authority – HRP plus scientific, budget, finance, other• Process streams, tracking• Governance: Authority, responsibility, control