IRB - Office of Clinical Research - University of Pittsburgh

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					University of Pittsburgh

              OSIRIS
       www.osiris.pitt.edu
        The IRB Electronic
       Submission Program
          Richard Guido, MD, IRB Chair
     Ari Beedle, Systems Program Manager
Introduction

 Single, dynamic, comprehensive electronic
 compliance system

 Automated logging and tracking system

 Single submission process for required
 pre-IRB approvals and IRB review

                University of Pittsburgh, 2006
Introduction (con’t)
 Utilizes smart forms which provide extensive
 branching questions to acquire information

 Automated review process based on
 responses in smart form

 Automated email notifications to permit
 direct communication between review
 entities and research staff
                University of Pittsburgh, 2006
Goals
 Improve human subject protections

 Assist investigators in the administration of
 research trials as the complexity of conducting
 research increases

 Reduce the review and approval cycles



                  University of Pittsburgh, 2006
User Groups

                       Investigator



        IRB                                         Ancillary
     Vice Chairs                                    Reviewers



                           Osiris


       Board
                                                    IRB Staff
      Members


                       UPitt/UPMC
                          Sites


                   University of Pittsburgh, 2006
Project Scope

 New Studies – Full                    Exceptions
 Board, Expedited                      Suspensions
 and Exempt                            Terminations
 Renewals                              Committee
 Modifications                         Meetings
 Adverse Events                        Help/Support
 Unanticipated
 Problems
                University of Pittsburgh, 2006
Ancillary Reviews

 Scientific Review                        Radiation Safety
 Fiscal Review                            rDNA
 Investigational                          RDRC
 Drug Service                             Conflict of Interest
 Mentor                                   DSMBs
 Clinical Trials Office



                   University of Pittsburgh, 2006
Project History
  Smart form questions developed by
  Dennis Swanson

  Kick-Off meeting with Webridge (Click
  Commerce)
 –   June 2003

  First Full Board Electronic Review
 – November 2005

                 University of Pittsburgh, 2006
Deployment Process

 Engaged all user groups
 –   Principal investigators/Research staff
 –   IRB board members
 –   Community members
 –   Ancillary reviewers
 –   GCRCs
 –   IRB staff


 Alpha testing 2005
                     University of Pittsburgh, 2006
PI Perspective
Allows for easy accessibility since internet based

Provides for integrated review process

Convenience of tracking study progress

Response to Smartform questions
 – Regulatory issues responses are required (*)

Approved consent forms are watermarked

                      University of Pittsburgh, 2006
Home Page




        University of Pittsburgh, 2006
User Home Page




         University of Pittsburgh, 2006
Study Workspace




        University of Pittsburgh, 2006
Create New Study




        University of Pittsburgh, 2006
Study Triage Section




         University of Pittsburgh, 2006
Study Cover Sheet




         University of Pittsburgh, 2006
Scientific Review




          University of Pittsburgh, 2006
Jump List




            University of Pittsburgh, 2006
View Progress




            University of Pittsburgh, 2006
Submit Study




         University of Pittsburgh, 2006
Pre IRB Review




         University of Pittsburgh, 2006
Department Approval




         University of Pittsburgh, 2006
Ancillary Review




         University of Pittsburgh, 2006
In Ancillary Review




          University of Pittsburgh, 2006
Respond to Comments




          University of Pittsburgh, 2006
PI Responds to Request




         University of Pittsburgh, 2006
IRB Member Perspective
Eliminates the “stack of paper”

Internet access
– Review studies anywhere

All reviewers will have access to all
materials

Allows for electronic editing of consent
                  University of Pittsburgh, 2006
My Meetings




          University of Pittsburgh, 2006
Meeting Agenda




        University of Pittsburgh, 2006
Reviewer Version


                                          Click on “reviewer
                                          notes” and this will
                                          take you directly to
                                          the page to write your
                                          comment.




         University of Pittsburgh, 2006
Add Review Note




         University of Pittsburgh, 2006
Viewing Modifications




          University of Pittsburgh, 2006
Complete Primary Review




         University of Pittsburgh, 2006
IRB Perspective
Required responses to regulatory issues will
improve human subject protections

Provides easier access to study information
– Generate reports

Better communication with research community

Improve office efficiency
– SAVE A FEW TREES!!!


                     University of Pittsburgh, 2006
Education Initiatives
 Web-based training
 – Internet education tool for the research
   community


 Onsite training and support

 Departmental training by demand

 Complete IRB member training by May 2006
                   University of Pittsburgh, 2006
Deployment Timeline
First electronic study approved
 – January 2006

UPCI, WPIC AND MWH
 – Summer 2006

All new study submitted
 – January 2, 2007

All submissions
 – Projected January 2008
                   University of Pittsburgh, 2006

				
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