Kuali Days 7 Kuali Coeus (KC) Research Compliance Animal Care and Use

1. Kuali Days 7Kuali Coeus (KC) Research Compliance Animal Care and Use E. Ray Stinson, Ph.D. Assistant Vice President for Research Compliance Cornell University November 18, 2008 Newport Beach, CA

2. What is KC? • Cradle-to-grave research administration system, based on MIT’s Coeus: • Pre-award (proposals, budgets, Grants.gov) • Post-award (contracts, grants, negotiations, report tracking, subcontracting) • Research Compliance • (IRB, IACUC*, COI*, IBC*, Export Controls*, Chemical Tracking*, etc) *Yet to be Developed in Coeus

3. KC Investing Partners • University of Arizona • Cornell University • Indiana University • Michigan State University • Coeus Consortium / MIT • Colorado State University • University of California-Davis • Iowa State University • University of California-Berkeley

4. Coeus • Originally Coeus was research administration software programs developed by MIT that was licensed to other academic institutions at little cost • Research Administration needs at other institutions resulted in development of the Coeus Consortium • 50 academic institutions participate at various levels – Steering, Development, Basic

5. KC Partners Participating in the Coeus Consortium • Steering Committee Schools • Cornell University, MIT • Development Schools • Michigan State University, Indiana University • Basic Schools • University of California - Berkeley

6. Long Term Strategy • Bring Coeus and KC into one research administration support partnership • While KC is converting Coeus to open source, future development efforts of Coeus cannot stop • While KC is working on making Coeus open source, KC institutions also need to be working on joint development with Coeus

7. Guiding Principle • Identify “best of breed” solutions from among partners as base for each module • Principle applies to all of research administration activities as well as individual modules within KC

8. Observations • No open source “best of breed” solution existed • Coeus is not open source but close • Coeus was interested in developing IACUC module • If a module can support complex Animal Care and Use Program, it can support all • Cornell (KC, Coeus), UC Davis (KC), Michigan State (KC, Coeus), Colorado State (KC), Purdue (Coeus)

9. KC Timeline

10. Animal Care and Use • KC IACUC Subject Matter Expert Development Team • Would expected to be appointed and working in advance of Release 3 (summer 2009) • Coeus IACUC Working Group (equivalent to KC Subject Matter Expert Development Teams) began work in 2008 • Joint Development of Animal Care and Use Module

11. Coeus Programmers QU Manager Jennifer Flack Co-Leader Lisa Snider – Purdue University KC Lead Business Analyst – Kenton Hensley Spec. Development Process and Template Co-Leader E. Ray Stinson – Cornell University Business Analyst IACUC – Joint Development

12. University of Arizona University of California, San Diego University of California, Davis Michigan State University Purdue University University of Tennessee SUNY, Binghamton University The Jackson Laboratory Cornel University Indiana University Drexel University Johns Hopkins University Dartmouth College Brown University Colorado State University Boston University KC – Coeus IACUCParticipating Institutions

13. Evolutionarily Development • Coeus IRB developed as an first Compliance Module • Initially framed in terms of the IRB terms and support • With IACUC module we asked ourselves • How much did we already have in the IRB module that is equivalent to IACUC module • Similarities with all Compliance Modules(fCOI, IBC, etc) • Similarities with other review committees • Limited Submission • Institutional (Internal) Review

14. Eureka • Coeus IRB is not just compliance module to support IRB • Coeus IRB is really a Research Compliance/Review support module that can be customized to support • Human Participants Research (IRB) • Animals (IACUC) • Biosafety (IBC) • Financial Conflict of Interest (fCOI) • Institutional Peer Review

15. IACUC and IRB Modules Similarities • Committee creation and scheduling • Submission of protocols (new, continued, amended) • Assigning protocols to agendas • Recording deliberations of meetings • Batch correspondence and correspondence generation • Preparing minutes • Notifications to Investigators • Protocol and training queries • Special reviews by other committees and grants

16. IACUC Module • Coeus 4.4 scheduled to be released in Spring 2009 • KC 3.0 scheduled to be released in 2010

17. KC Release 3.0 – Fall 2010 • Animal Care and Use – Enhancements • Inspections • Procurement – Requisition • Receiving and cage card management • Animal Census • Regulatory/Non-regulatory Reporting – OLAW (Annual Report); USDA (Annual report); AAALAC-I (Annual Report) • Training and Educational Requirements • Concurrence and Post-approval monitoring

18. IRB Not within the Human Research Protection Program Exemption from IRB review Expedited Full IACUC Not within the Animal Care and Use Program Exemptions from IACUC review Designated Review Full IRB vs. IACUC Protocols

19. SME/Working Group Current Assignments • A number of Spec. Documents have been converted to the new template and amended to reflect IACUC requirements • Identifying information uniquely needed by the animal care and use program • Identifying where to place that information

20. Components of a IRB/IACUC Protocol • Basic Information • Questionnaire • Attachments • IRB (Informed Consents, Recruitments Materials, etc.) • IACUC (Species Specific Standard Operating Procedures)

21. IACUC Specific • Species – Basic Information • Locations – Basic Information • Pain Levels – Basic Information • Analgesics – Basic Information, Questionnaires • Anesthesia Agents – Basic Information, Questionnaires • Restraints – Basic Information, Questionnaires

22. KC SME Focus • IRB • Conversion of Coeus IRB to KC IRB • Development of Initial Spec. Documents • Development of screen mockups • SMEs review screen mockups • Developers build code • Testers do quality assurance and report issues • fCOI • Questionnaire • IACUC • Conversion of Spec Documents to new format, • Annotating Spec Documents to reflect special requirements for Animal Care and Use • Begin to develop generic compliance/committee review module