1. CTSA Improvements in Clinical Research Management Daniel Rosenblum CTSA Clinical Research Management Coordinator NCRR rosenblumd@mail.NIH.gov Secretary’s Advisory Committee on Human Research Protections October 19, 2010

2. 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)

3. 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

4. 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

5. 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