Transcript Kuali PowerPoint

Kuali Research Administration IRB
Dan Dwyer, Research Administration Information Services
E. Ray Stinson, Office of Research Integrity and Assurance
Cornell University
Kuali Research Administration IRB
Coeus IRB History
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
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
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
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Compliance Sub-committee
Technical Sub-committee
Pre-Award Sub-committee
Post-Award Sub-committee
Membership and Operations Sub-committee
Coeus
• Two methods for end users to enter data into the
same Coeus database.
– Coeus Lite – 100% web-based interface for the endusers 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.
Coeus
• Compliance Sub-committee
Responsibilities
– IRB
• Adverse Events (to be developed)
– Financial Conflict of Interest
– IACUC (to be developed)
– IBC (to be developed)
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
Coeus IRB
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Components of Coeus IRB
1. Submission of protocols to the IRB Administrative
Office
2. Assignment of protocols to an IRB and specific
reviewers
3. Development of IRB Agenda
4. Review of the protocols by IRB reviewers
5. Creation of Memos of Concerns/Approval to
Investigators
6. Electronic creation of minutes
Coeus IRB
• Types of Submissions processed by the IRB
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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
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
Kuali Research Administration IRB
Functional Development Process
Mapping Coeus to Kuali
Kuali IRB
Coeus
Premium &
Lite
Goals
• Maintain all functionality from the Coeus
product
• Apply development infrastructure & user
interface consistent with Kuali
• Identify critical enhancements for
consideration in Kuali product
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
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
Process: Module Development
Steps
1. SMEs review current product (Coeus)
functionality
2. SMEs write specification documents
a. Enhancements to FC for review/vote
b. FC keeps tabs on scope throughout
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Usability group build screen mockups
SMEs review screen mockups
Developers build code
Testers do quality assurance and report issues
Tools
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Coeus test system
Mock screens
Conference Conferencing (Breeze)
Wiki (Confluence)
Standard documentation templates
KRA Glossary
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
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
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
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
Kuali Research Administration IRB
Thinking Ahead about KRA IRB
Implementation
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?
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
Kuali Research Administration IRB
Cornell KRA IRB Support Mechanisms
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
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
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
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