Ctsa improvements in clinical research management
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CTSA Improvements in Clinical Research Management . Daniel Rosenblum CTSA Clinical Research Management Coordinator NCRR [email protected] Secretary’s Advisory Committee on Human Research Protections October 19, 2010 .

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CTSA Improvements in Clinical Research Management

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Ctsa improvements in clinical research management

CTSA Improvements in Clinical Research Management

Daniel Rosenblum

CTSA Clinical Research Management Coordinator

NCRR

[email protected]

Secretary’s Advisory Committee on Human Research Protections

October 19, 2010


Protocol approval related improvements in clinical research management at ctsa sites

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)


Ctsa improvements in clinical research management

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


Ctsa improvements in clinical research management

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


Ctsa improvements in clinical research management

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


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