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Update on the Enterprise Initiative: e-IRB and More

Update on the Enterprise Initiative: e-IRB and More. Riyad Naser, MS, MBA Director of Research Information Systems Karen Blackwell, MS, CIP Director, Human Research Protection Program. CRIS Enterprise Initiative. Initiative Goals Initiative Components Where We Are GCRC Implementation

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Update on the Enterprise Initiative: e-IRB and More

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  1. Update on the Enterprise Initiative: e-IRB and More Riyad Naser, MS, MBA Director of Research Information Systems Karen Blackwell, MS, CIPDirector, Human Research Protection Program

  2. CRIS Enterprise Initiative • Initiative Goals • Initiative Components • Where We Are • GCRC Implementation • RI Implementation • E-IRB

  3. Initiative Goals • Standardize our processes • Integrate research with clinical practice • Integrated disciplines / departments • Improve data quality • Improve operational efficiency • Facilitate inter-institutional collaboration

  4. CRIS Enterprise Initiative Dependencies PeopleSoft / EHR

  5. Initiative Timeline

  6. Approaching the Enterprise • Enterprise Level • Department Level • Vendor Level

  7. Where to Start? DISCOVERY PHASE: Current State

  8. Current Hardware Environment

  9. Standardizing Plan • GCRC protocol and patient management • CReDO regulatory office • E-IRB Process

  10. CReDO regulatory office • Have a very detailed tracking system • Capture research data in CRIS early on • Manage their expectations

  11. CReDOregulatory office..Migration

  12. E-IRB • What? • Why? • How?

  13. Current Process of HSC Submissions • Everything is received, reviewed and processed on paper • Routing on paper • Time consuming for investigators • Questions or additional forms may be missed, slowing the review • Submissions go into a “black box”

  14. Paper Review by the HSC • Over 4300 actions in 2008 • Printing costs in FY2008 were $28,000. • Paper files are transported between desks and tables • Reviews are on paper; provisos are transcribed from paper • Lots of copying and filing

  15. Transforming IRB Review • Automate the entire submission process • Prompts for missing questions or additional forms • Automated scientific review and department sign-off • Ancillary review (COI, RSC) would be automatically routed • PRMC and GCRC functions would be housed in the same system

  16. Transforming IRB Review - 2 • Significant time-saving throughout the review process • Electronic routing for review • Electronic capture of reviewer comments • Results can be distributed more efficiently • Entire history of the project in one location • More effective review

  17. Benefits on All Levels • Advantages for Investigators • Improvements for Compliance • Advantages for the Institution

  18. Current StateIRB Approval Process Application is rushed to HSC Office Who is the reviewer? Paperwork dilemma Application is printed from HSC Website Reviewer Load and responsibility Meeting time, going through paper trail Review is done, time to issue Approvals

  19. Future State: e-IRB CRIS

  20. E-IRB –Submitting a new application

  21. E-IRB –Completeness check

  22. E-IRB –Pending Items

  23. E-IRB –Ongoing Studies

  24. E-IRB………Manage Submissions

  25. E-IRB………Reviewer Area

  26. E-IRB………Manage Meetings

  27. E-IRB Next Steps… • Testing Phase • Migration • Go Live • Phase Approach • “Cold Turkey” Approach

  28. Future Implications • Standardize data collection and Approval process:e.g. baseline demographics, toxicity, laboratory forms, etc.) used in clinical research will become standardized in one system. Once a form is created, this template can be applied to any study • Centralized location to track protocols and subject data • Consolidate all protocol and subject information into one database, eliminating the need for stand-alone databases.

  29. QUESTIONS?

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