open source administration software for education

research administration

The Lifecycle of an IRB Protocol in KC

Joseph Abraham, Cornell UniversityDan Dwyer, Cornell UniversityWeiwen Sung, Iowa State University

open source administration software for education

Session Agenda

The Lifecycle of an Institutional Review Board (IRB) Protocol in Kuali Coeus (KC)• Kuali Coeus Overview• IRB Functionality• Demonstration

open source administration software for education

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

open source administration software for education

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

open source administration software for education

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

open source administration software for education

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

open source administration software for education

research administration

Demonstration

open source administration software for education

Process Map

open source administration software for education

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

open source administration software for education

Researcher: Create Protocol

open source administration software for education

Researcher: Enter Protocol Data

open source administration software for education

Researcher: Submit Protocol

open source administration software for education

Admin: Lookup Submissions

open source administration software for education

Admin: Committee and Agenda

open source administration software for education

Admin: Assign Reviewer

open source administration software for education

Reviewer: Search All My Reviewers

open source administration software for education

Reviewer: Enter Review Comment

open source administration software for education

Admin: manage review comment & committee decision

open source administration software for education

Admin: Modify Minutes

open source administration software for education

Admin: Generate Minutes

open source administration software for education

Reviewer: View Minutes

open source administration software for education

Researcher: Create Amendment

open source administration software for education

Researcher: Change Title

open source administration software for education

Researcher: Submit Amendment

open source administration software for education

Admin: Return for Minor Revisions

open source administration software for education

Researcher: Submit with Revisions

open source administration software for education

Admin: Expedited Approval

open source administration software for education

Researcher: Notify IRB

open source administration software for education

Admin: Acknowledge Notification

open source administration software for education

Researcher: Create Renewal

open source administration software for education

Researcher: Submit Renewal

open source administration software for education

Admin: Approve Renewal

open source administration software for education

Admin: Expire Protocol

open source administration software for education

Researcher: View History

open source administration software for education

Kuali Coeus IRB References

• Kuali Coeus Information – http://www.kuali.org/kc/overview

• Test Drive – http://www.kuali.org/test-drives