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Kuali Coeus IRB Kuali Days, November 18, 2008

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Kuali Coeus IRB Kuali Days, November 18, 2008. E. Ray Stinson, Office of Research Integrity and Assurance Dan Dwyer, Research Administration Information Services Cornell University. Session Agenda. Coeus IRB History & Current State KC IRB Development Process

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  1. Kuali Coeus IRBKuali Days, November 18, 2008 E. Ray Stinson, Office of Research Integrity and Assurance Dan Dwyer, Research Administration Information Services Cornell University

  2. Session Agenda • Coeus IRB History & Current State • KC IRB Development Process • KC IRB User Interface – Mock Screens • Coeus & KC – Continuing Collaboration

  3. Kuali Coeus IRB Coeus IRB History & Current State

  4. Coeus IRB • Planning for Coeus IRB started in 2003 • First roll out was in 2005 for Administrative Support (Back Office Operations) • Version 4.3 has an improved Lite interface to better support submission of protocols to the IRB

  5. Coeus IRB • Components of Coeus IRB • Submission of protocols to the IRB Administrative Office • Assignment of protocols to an IRB and specific reviewers • Development of IRB Agenda • Review of the protocols by IRB reviewers • Creation of Memos of Concerns/Approval to Investigators • Electronic creation of minutes

  6. Coeus IRB • Coeus IRB is overseen by the Compliance Subcommittee • Other responsibilities include • Financial Conflict of Interest (upgrade as part 4.3.1) • IACUC (to be developed) • IBC (to be developed) • IRB Adverse Events (to be developed)

  7. Kuali Coeus IRB KC IRB Development Process

  8. Kuali Coeus Goals • Maintain all functionality from the Coeus product • Apply development infrastructure & user interface consistent with Kuali • Identify critical enhancements for consideration in Kuali product

  9. KC IRB Timeline • KC IRB will be part of Release 2 • Functional specs and mock screens are in progress • Code development began in fall 2008 • First version of KC IRB anticipated to be released by August 2009

  10. Process: Module Development Steps • Subject Matter Experts (SMEs) review current product (Coeus) functionality • SMEs write specification documents • Enhancements to FC for review/vote • FC keeps tabs on scope throughout • Usability group build screen mockups • SMEs review screen mockups • Developers build code • Testers do quality assurance and report issues

  11. Kuali Coeus IRB The User Interface Mock Screens https://www.kuali.org/mocks/kra-irb-dev/irb-protocol.html

  12. Navigation Elements

  13. Committee Management

  14. Member Management

  15. Schedule Maintenance

  16. Required Fields

  17. Status & Dates

  18. Additional Information

  19. Organization

  20. Funding Sources

  21. Participant Types

  22. Personnel

  23. Custom Data

  24. Questions

  25. Special Review

  26. Permissions

  27. Attachments

  28. Notes

  29. Actions • Many actions will be taken against a protocol during its normal lifecyle • Available actions are dependent on current status of protocol plus the role & rights of user • Data may be collected at time of action • Multiple actions may be required serially • User interface design is critical to user experience

  30. Protocol Actions

  31. Request an Action

  32. History

  33. Summary

  34. Print

  35. Kuali Coeus IRB Coeus & KC – Continuing Collaboration

  36. Coeus/KC Collaboration • New development in Coeus IRB is ongoing with significant enhancements in recent releases • Coeus consortium members participate in KC SME group • KC SME members attend Coeus Compliance Committee meetings • Two KC partners currently implementing Coeus IRB

  37. Keys to Success • A solid Coeus IRB base to build on • Structured Kuali process • Involvement of functional experts (SMEs) • A quality flexible product is critical to successful implementations • Migration path for Coeus IRB users • Good working relationship between Kuali and Coeus

  38. Questions? KC IRB Lab Salon 1-2 5:00 to 6:00