ctsa improvements in clinical research management
Download
Skip this Video
Download Presentation
CTSA Improvements in Clinical Research Management

Loading in 2 Seconds...

play fullscreen
1 / 5

CTSA Improvements in Clinical Research Management - PowerPoint PPT Presentation


  • 97 Views
  • Uploaded on

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 .

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' CTSA Improvements in Clinical Research Management ' - ciara


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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)
slide3
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
slide4

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
slide5

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
ad