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Kuali Coeus IRB Kuali Days, November 18, 2008

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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Kuali Coeus IRB Kuali Days, November 18, 2008

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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

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