Kuali Research Administration IRB

1. Kuali Research Administration IRB Dan Dwyer, Research Administration Information Services E. Ray Stinson, Office of Research Integrity and Assurance Cornell University

2. Kuali Research Administration IRB Coeus IRB History

3. Coeus • Coeus is an University Electronic Research Administration System • Originally developed (1996) by the Massachusetts Institute of Technology • Named after the Greek Titan of Intelligence (not an acronym) • Created to assist the research community in proposal development and pre- and post award administration

4. Coeus • Software makes it possible to prepare proposals/protocols, route them to obtain internal approvals, and submit them to sponsors (grants.gov) and compliance review committees electronically • In 2006 Coeus Consortium was initiated to enable long-term sustainability as a shared resource

5. Coeus • Consortium now has 44 members • Types of Membership • Basic, Development, Steering Members Schools • In addition to Executive and Steering Committees, Coeus has functional subcommittees • Compliance Sub-committee • Technical Sub-committee • Pre-Award Sub-committee • Post-Award Sub-committee • Membership and Operations Sub-committee

6. Coeus • Two methods for end users to enter data into the same Coeus database. • Coeus Lite – 100% web-based interface for the end-users to submit grant application, IRB protocols, and COI disclosures • Coeus Premium is a full featured application which utilizes standard technology. • Designed for functional and business level people to control routing, business rules, rates, cost elements, unit hierachy, IRB committee and meeting schedules and all the other functions needed to make Coeus a comprehensive research administration application.

7. Coeus • Compliance Sub-committee Responsibilities • IRB • Adverse Events (to be developed) • Financial Conflict of Interest • IACUC (to be developed) • IBC (to be developed)

8. Coeus IRB • Planning for Coeus IRB started in FY 2003-4 • First roll out was in 2005 for Administrative Support (Backend Operations) • Version 4.4 (Scheduled release Dec 2007) has a user front end to allow submission of protocols to the IRB

9. Coeus IRB • Components of Coeus IRB • 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 reviewers • Creation of Memos of Concerns/Approval to Investigators • Electronic creation of minutes

10. Coeus IRB • Types of Submissions processed by the IRB • Exemption • Expedited • New Protocol (Full Committee) • Continuations • Amendments • Closure • NOTE: Processing Unexpected Event/Adverse Event is a separate module that will be developed in the future

11. KRA-Coeus • Coeus is the product leader for Electronic Research Administration • KRA started July 1, 2007 • KRA licensed Coeus software as the basis for all future KRA software • KRA and Coeus working together on the development of new compliance modules (IACUC, Unexpected Events) • KRA scheduled to replace Coeus Lite as the user interface for all Coeus applications • There is the hopes that KRA and Coeus will eventually become one product

12. Kuali Research Administration IRB Functional Development Process

13. Mapping Coeus to Kuali Coeus Premium & Lite Kuali IRB

14. Goals • Maintain all functionality from the Coeus product • Apply development infrastructure & user interface consistent with Kuali • Identify critical enhancements for consideration in Kuali product

15. KRA IRB Timeline • KRA IRB will be part of Release 2 • Functional specs and mock screens are in progress • Code development will commence after completion of Release 1 • First version of KRA IRB anticipated to be released in August 2009

16. Process: Subject Matter Experts (SMEs) • Group is formed with two to four members per partner institution. Participants part time • Lead SME is identified. Works closely with development manager & business analyst • Weekly conference calls and possible, but infrequent face-to-face meeting

17. Process: Module Development Steps • SMEs review current product (Coeus) functionality • SMEs write specification documents • Enhancements to FC for review/vote • FC keeps tabs on scope throughout • Usability group build screen mockups • SMEs review screen mockups • Developers build code • Testers do quality assurance and report issues

18. Tools • Coeus test system • Mock screens • Conference Conferencing (Breeze) • Wiki (Confluence) • Standard documentation templates • KRA Glossary

19. Challenges: User Interface • Coeus Premium provides tools for IRB office staff to manage protocol lifecycle • Coeus Lite provides protocol submission capability • KRA IRB provides single, consistent interface; possibility of different views for different constituents

20. Challenges: Anticipating Future Development • KRA expects to build other compliance modules (e.g., IACUC and IBC) • KRA IRB SME group is attempting to design generalized solutions. Examples: • Committee process • Protocol workflow • Agendas and minutes

21. Coeus/KRA Collaboration • New development in Coeus IRB is ongoing with significant enhancements in recent releases • Coeus consortium members participate in KRA SME group • KRA SME members attend Coeus Compliance Committee meetings • Two KRA partners currently implementing Coeus IRB

22. Keys to Success • Solid Coeus IRB base to build on • Involvement of functional experts (SMEs) • Involvement of Coeus experts (Coeus Consortium member participation) • Structured Kuali process • Regular meetings with regular core group participation • Good working relationship between KRA and Coeus

23. Kuali Research Administration IRB Thinking Ahead about KRA IRB Implementation

24. Global Implementation Issues • Building a quality flexible product is critical to successful implementations • Migration path for Coeus IRB users • Interoperability between Coeus and KRA components?

25. Local Implementation Issues • Implementing Coeus IRB now as step towards KRA IRB • Initiating implementation planning now • Negotiating funding and resources availability • Key KRA development players (technical and functional) will become key KRA implementation players

26. Kuali Research Administration IRB Cornell KRA IRB Support Mechanisms

27. Coeus IRB Implementation • Cornell-Weill Medical College has implemented Coeus IRB • Cornell-Ithaca is in the process of implementing Coeus IRB as an interim solution until KRA IRB is available • Cornell’s IRB is administratively supported by the Office of Research Integrity and Assurance (ORIA) • In addition to central CIT support, computer support provided by Research Administration Information Services

28. Coeus IRB Implementation • CU KRA Steering Committee (Includes Coeus) • Compliance Development/Implementation Teams • Coeus IRB Implementation Team • KRA Financial COI Development Team • KRA IACUC Development Team

29. IRB Implementation Team • Faculty Advisory Committee • Faculty/Staff Focus Groups • Because IRB is being implemented in addition to being developed, IRB Implementation Team is serving three roles—(1) Implementation, (2) Coeus System Development, and (3) KRA System Development

30. Coeus IRB Implementation • IRB Implementation Team • Asst. VP for Research Compliance • Research Compliance Coordinator • IRB Administrator • Education Coordinator • Director, Research Admin Information Services (RAIS) [IRB SME Leader] • RAIS Program Analysis