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843-792-8300 https://sctr.musc.edu/index.php/programs/teach

South Carolina’s Electronic IRB Collaboration For CTSA Consortium Child Health Oversight Committee (CC-CHOC). Kathleen Brady, MD – PI, SCTR Jay Moskowitz, PhD – President, HSSC Iain Sanderson, BM, BCh – Director, Biomedical Informatics Randy Shelley- Project Manger.

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843-792-8300 https://sctr.musc.edu/index.php/programs/teach

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  1. South Carolina’s Electronic IRB Collaboration For CTSA Consortium Child Health Oversight Committee (CC-CHOC) Kathleen Brady, MD – PI, SCTR Jay Moskowitz, PhD – President, HSSC Iain Sanderson, BM, BCh – Director, Biomedical Informatics Randy Shelley- Project Manger Monday January 30, 2012, 13:40-13:55 ET http://sctr.musc.edu 843-792-8300 843-792-8300 https://sctr.musc.edu/index.php/programs/teach

  2. Acknowledgements • Funded by NCRR/ CTSA Grant 1UL1RR029882-01 (7/14/09-03/31/14) • South Carolina Clinical & Translational Research Institute (SCTR) • Dr. Kathleen Brady (PI) • And by • And Randy Shelly – who singlehandedly launched and implemented the majority of this project, and did it very well. http://sctr.musc.edu 843-792-8300

  3. SC Clinical and Translational Science Institute (SCTR) Health Sciences South Carolina (HSSC) Spartanburg Regional HealthSystem Greenville Hospital System Clemson University University ofSouth Carolina Palmetto Health MUSC http://sctr.musc.edu/ Self Regional ANMED McLeod http://www.healthsciencessc.org/ New Affiliates…

  4. What’s interesting about SCTR & HSSC • A collaborative of otherwise unaffiliated (competitive) hospitals and universities with the goal of improving healthcare for the State through integrated translational research initiatives. • Spirit of cooperation (DURSA, reciprocal eIRB agreement etc.) • Collaboration of HSSC and CTSA funded centers (MUSC’s South Carolina Clinical and Translational Research Institute – SCTR) • - Alignment of Informatics initiatives, sharing staff and infrastructures. • Funded by a combination of Philanthropy (The Duke Endowment), CTSA (NCRR), NLM (GO Grant), Private Hospital, State Match (For Endowed Chairs and Faculty). http://sctr.musc.edu 843-792-8300

  5. We have built a capable, distributed Biomedical Informatics Program and IT service organization… Project Management Core Hosting and Security Core Academic Biomedical Informatics, Development And Support Cores http://sctr.musc.edu 843-792-8300

  6. Wins - System Components Towards SCIPR – The South Carolina Integrated Platform for Research http://sctr.musc.edu 843-792-8300

  7. eIRB – Goals Cooperative review to reduce the barriers To multi-site studies across SC http://sctr.musc.edu 843-792-8300

  8. Vendor Selection • Click Commerce (eResearch Portal) • Now Huron Click • Successfully implemented at many top research universities and medical centers • Business to Businesssmart forms. WYSIWYGform creation and workflow engine. http://sctr.musc.edu 843-792-8300

  9. The HSSC eIRB Workgroup • Project Manager was selected to lead the effort – Randy Shelley • Each participating institution appointed an experienced IRB Coordinator to the workgroup • Project Charter and project management tools implemented • Project began on July 2006 http://sctr.musc.edu 843-792-8300

  10. eIRB – Preparation and Analysis • IRB Workflow definition • Dozens of workflows likethis one • Took over a year! http://sctr.musc.edu 843-792-8300

  11. Define eIRB SmartFormsTM http://sctr.musc.edu 843-792-8300

  12. Develop eIRB SmartFormsTM http://sctr.musc.edu 843-792-8300

  13. Implement eIRB SmartFormsTM • SmartForm branching logic! http://sctr.musc.edu 843-792-8300

  14. eIRB- Features Supports all major IRB submissions New applications (Full, Expedited, Exempt) Amendments, Continuing Reviews, Reportable Events Multi-site collaborative review process Cooperative Review and Facilitated Review Electronic workflow routing Automatic email notifications Access to IRB best practices Configurable application architecture Smart forms, workflow and reporting Multi- institutional Single Sign on via Shibboleth http://sctr.musc.edu 843-792-8300

  15. eIRB- Timeline • 2005 – Create the HSSC IRB Committee and define requirements • 2006 – “Cooperative Agreement-Institutional Review Boards” signed • 2008 – Implement Greenville Hospital System, Palmetto Health, Spartanburg Regional Healthcare System and University of South Carolina on the HSSC eIRB platform with the goal to unify and streamline their IRB operations. • 2010 – Medical University of South Carolina becomes operational. • 2010 – Implement multi-site collaborative review process within eIRB. Each institution designates reliance upon each of the others institution’s IRB allowing the institutions to cooperate in human research studies and avoid duplication of effort. • 2010 – Scresearch.org goes live with studies from eIRB. • 2011 – Implement facilitated review process with eIRB to reduce the administrative burden for IRB and investigative staffs who are associated with the local review process of studies approved through the NCI CIRB, other Central IRB or non-HSSC IRB. http://sctr.musc.edu 843-792-8300

  16. eIRB – Cooperative Review Investigator submits a multi-site Research Study to the Primary IRB Request Changes Investigator submits an Amendment to the Primary IRB Primary IRB review Primary IRB Approval Cooperative Review request notification is sent to all Collaborating IRBs and is immediately available for their Cooperative Review Request Changes Study must be submitted directly to the Collaborating IRB and not through Cooperative Review Process Reject Primary IRB Approval Collaborating IRBs records cooperative review decision (Full Board or Expedited) Research may now be conducted at collaborating institution Accept Primary IRB Approval http://sctr.musc.edu 843-792-8300

  17. eIRB - Stats • Now Rolled out across 5 institutions in SC (all HSSC except Clemson – no human studies – managed by Greenville) • 12 IRB committees • 4 MUSC • 3 Greenville Hospital System • 2 Palmetto Health • 2 Spartanburg Regional • 1 University of South Carolina • 4,400 Approved Studies • 1,900 Active studies • 1,600 Exempt Studies • 4,700 approved amendments • 29 approved studies using “cooperative review” • 3 approved studies using “facilitated review” • 300 logged on users in the 24 hr period until Jan17th 1pm. http://sctr.musc.edu 843-792-8300

  18. eIRB Project Costs - Sustainability Annual Cost of system = $510k ( 3 FTEs, Vendor license, vendor support, Clemson hosting, HSSC overhead) Allocated by # of IRB committees supported ( 12 in total) • Cost Allocation • MUSC - $168k • Greenville -$128k • Spartanburg - $86k • Palmetto - $86k • USC - $43k http://sctr.musc.edu 843-792-8300

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