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 Kuali Coeus (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 Kuali Coeus?
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 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
Resubmit Amendment with Revisions
Approve Amendment with Revisions
Notify IRB (w/ attachment)
Acknowledge
Renewal
Approve Renewal 
Expire Protocol
Review Summary & History

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 –
Test Drive –