Transcript Kuali PowerPoint

Kuali Days 7
Kuali 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
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
KC Investing Partners
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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
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
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
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
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
Observations
1. No open source “best of breed” solution
existed
• Coeus is not open source but close
• Coeus was interested in developing IACUC
module
2. 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)
KC Timeline
KC & COEUS Development Merger
Timeline
Release 1.0
Release 2.0
Kuali Rice Integration
Startup
Proposal & Budget 8300 (8)
IRB / Human Participants 10000 ( )
Awards
4000 ( )
Conflict of Interest
2000 ( )
Release 3.0
Release 3.1
Negotiations
1400 ( )
Report Tracking
4000 ( )
Subcontracts
1400 ( )
COEUS
Merger
Catch-up
Required Hours (# Developers)
Release 4.0
Bio-Safety
Animal Care and Use
Export Controls
Release 1.1
2007
November 2008
2008
4000 ( )
Enhancements
4200 ( )
Development COEUS 4.5
(contents TBD)
Release 1.1
Nov 2008
Release 1.0
Jul 2008
4000 ( )
Chemical
Tracking
Budget
COEUS 4.4
(contents known)
1400 ( )
8000 ( )
2009
2010
Release 2.0
Aug 2009
COEUS 4.4
Apr 2009
COEUS 4.5
Apr 2010
Release 3.0
Sep 2010
2011
Release 3.1
Apr 2011
aka
COEUS 5.0
2012
Release 4.0
Apr 2012
Oct
Q4
Jul
Q3
Apr
Q2
Jan
Q1
Oct
Q4
2012
Jul
Q3
Apr
Q2
Jan
Q1
2011
Oct
Q4
Jul
Q3
Apr
Q2
Jan
Q1
Oct
Q4
Jul
Q3
Apr
Q2
Jan
Q1
Oct
Q4
Quality Assurance
Deployment
2010
2009
Jul
Q3
Apr
Q2
Jan
Q1
Oct
Q4
2008
Jul
Q3
Apr
Q2
Jan
Q1
2007
Development
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
IACUC – Joint Development
• 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
KC – Coeus IACUC
Participating Institutions
1. University of Arizona
2. University of California,
San Diego
3. University of California,
Davis
4. Michigan State
University
5. Purdue University
6. University of Tennessee
7. SUNY, Binghamton
University
8. The Jackson Laboratory
9. Cornel University
10. Indiana University
11. Drexel University
12. Johns Hopkins
University
13. Dartmouth College
14. Brown University
15. Colorado State
University
16. Boston University
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
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
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Human Participants Research (IRB)
Animals (IACUC)
Biosafety (IBC)
Financial Conflict of Interest (fCOI)
Institutional Peer Review
IACUC and IRB Modules
Similarities
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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
IACUC Module
• Coeus 4.4 scheduled to be released in
Spring 2009
• KC 3.0 scheduled to be released in 2010
KC Release 3.0 – Fall 2010
• Animal Care and Use – Enhancements
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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
IRB vs. IACUC Protocols
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• IRB
Not within the Human
Research Protection
Program
Exemption from IRB
review
Expedited
Full
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• IACUC
Not within the Animal
Care and Use
Program
Exemptions from
IACUC review
Designated Review
Full
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
Components of a
IRB/IACUC Protocol
• Basic Information
• Questionnaire
• Attachments
– IRB (Informed Consents, Recruitments
Materials, etc.)
– IACUC (Species Specific Standard Operating
Procedures)
IACUC Specific
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Species – Basic Information
Locations – Basic Information
Pain Levels – Basic Information
Analgesics – Basic Information, Questionnaires
Anesthesia Agents – Basic Information,
Questionnaires
• Restraints – Basic Information, Questionnaires
KC SME Focus
• IRB
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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