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The Lifecycle of an IRB Protocol in KC

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Presentation on theme: "The Lifecycle of an IRB Protocol in KC"— Presentation transcript:

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 –

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