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research administration
The Lifecycle of an IRB Protocol in KC
Joseph Abraham, Cornell UniversityDan Dwyer, Cornell UniversityWeiwen Sung, Iowa State University
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Session Agenda
The Lifecycle of an Institutional Review Board (IRB) Protocol in Kuali Coeus (KC)• Kuali Coeus Overview• IRB Functionality• Demonstration
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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
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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
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Kuali Coeus IRB Functionality
1. Submission of protocols to the IRB administrative office2. Assignment of protocols to an IRB and specific reviewers3. Development of IRB agenda4. Review of the protocols by IRB5. Correspondence generation6. Electronic creation of minutes7. Responses from researcher8. Protocol management actions by IRB administrator9. Issue approval notices
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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
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research administration
Demonstration
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Process Map
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1. Create a Protocol & Submit
2. Receive Protocol & Assign for Review
3. Online Review4. Record Committee
Decision and Approval5. Submit Amendment for
Expedited Review6. Request Specific Minor
Revisions
7. Resubmit Amendment with Revisions
8. Approve Amendment with Revisions
9. Notify IRB (w/ attachment)10. Acknowledge 11. Renewal12. Approve Renewal 13. Expire Protocol14. Review Summary & History
Demonstration Steps
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Researcher: Create Protocol
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Researcher: Enter Protocol Data
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Researcher: Submit Protocol
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Admin: Lookup Submissions
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Admin: Committee and Agenda
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Admin: Assign Reviewer
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Reviewer: Search All My Reviewers
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Reviewer: Enter Review Comment
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Admin: manage review comment & committee decision
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Admin: Modify Minutes
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Admin: Generate Minutes
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Reviewer: View Minutes
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Researcher: Create Amendment
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Researcher: Change Title
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Researcher: Submit Amendment
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Admin: Return for Minor Revisions
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Researcher: Submit with Revisions
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Admin: Expedited Approval
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Researcher: Notify IRB
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Admin: Acknowledge Notification
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Researcher: Create Renewal
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Researcher: Submit Renewal
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Admin: Approve Renewal
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Admin: Expire Protocol
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Researcher: View History
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Kuali Coeus IRB References
• Kuali Coeus Information – http://www.kuali.org/kc/overview
• Test Drive – http://www.kuali.org/test-drives