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The Lifecycle of an IRB Protocol in KC

The Lifecycle of an IRB Protocol in KC. Joseph Abraham, Cornell University Dan Dwyer, Cornell University Weiwen Sung, Iowa State University. Session Agenda. The Lifecycle of an Institutional Review Board (IRB) Protocol in Kuali Coeus (KC) Kuali Coeus Overview IRB Functionality

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The Lifecycle of an IRB Protocol in KC

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  1. The Lifecycle of an IRB Protocol in KC Joseph Abraham, Cornell University Dan Dwyer, Cornell University Weiwen Sung, Iowa State University

  2. Session Agenda The Lifecycle of an Institutional Review Board (IRB) Protocol in KualiCoeus (KC) • Kuali Coeus Overview • IRB Functionality • Demonstration

  3. Why an electronic system? • Efficiency • Eliminate paper, distribution processes • Conserve resources • Staff and Researcher time, money saved • Standardize processes • Integration with other systems • Gather data for information delivery and reporting

  4. Why KualiCoeus? • Functionally equivalent with Coeus - initially developed by MIT and implemented by over 40 institutions • A common interface and user experience across all research administration systems • Open source solution reduces licensing costs • Kuali Coeus Community - Power of national consortium for support, enhancements and subject matter expertise

  5. Kuali Coeus IRB Functionality • 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 • Correspondence generation • Electronic creation of minutes • Responses from researcher • Protocol management actions by IRB administrator • Issue approval notices

  6. Kuali Coeus IRB Interface Portal interface to present common actions based on role Consistent interface for navigating through document and entering data across all research administration modules Dynamic list of actions drive by role and current state of protocol Local configuration without customization

  7. Demonstration

  8. Process Map

  9. Demonstration Steps • Resubmit Amendment with Revisions • Approve Amendment with Revisions • Notify IRB (w/ attachment) • Acknowledge • Renewal • Approve Renewal  • Expire Protocol • Review Summary &History • Create a Protocol &Submit • Receive Protocol & Assign for Review • Online Review • Record Committee Decision and Approval • Submit Amendment for Expedited Review • Request Specific Minor Revisions

  10. Researcher: Create Protocol

  11. Researcher: Enter Protocol Data

  12. Researcher: Submit Protocol

  13. Admin: Lookup Submissions

  14. Admin: Committee and Agenda

  15. Admin: Assign Reviewer

  16. Reviewer: Search All My Reviewers

  17. Reviewer: Enter Review Comment

  18. Admin: manage review comment & committee decision

  19. Admin: Modify Minutes

  20. Admin: Generate Minutes

  21. Reviewer: View Minutes

  22. Researcher: Create Amendment

  23. Researcher: Change Title

  24. Researcher: Submit Amendment

  25. Admin: Return for Minor Revisions

  26. Researcher: Submit with Revisions

  27. Admin: Expedited Approval

  28. Researcher: Notify IRB

  29. Admin: Acknowledge Notification

  30. Researcher: Create Renewal

  31. Researcher: Submit Renewal

  32. Admin: Approve Renewal

  33. Admin: Expire Protocol

  34. Researcher: View History

  35. Kuali Coeus IRB References Kuali Coeus Information – http://www.kuali.org/kc/overview Test Drive – http://www.kuali.org/test-drives

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