Kuali Research Administration IRB

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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. - PowerPoint PPT Presentation

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  • Kuali Research Administration IRBDan Dwyer, Research Administration Information ServicesE. Ray Stinson, Office of Research Integrity and AssuranceCornell University

  • Kuali Research Administration IRBCoeus IRB History

  • CoeusCoeus is an University Electronic Research Administration SystemOriginally developed (1996) by the Massachusetts Institute of TechnologyNamed after the Greek Titan of Intelligence (not an acronym) Created to assist the research community in proposal development and pre- and post award administration

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

  • CoeusConsortium now has 44 membersTypes of Membership Basic, Development, Steering Members SchoolsIn addition to Executive and Steering Committees, Coeus has functional subcommitteesCompliance Sub-committeeTechnical Sub-committeePre-Award Sub-committeePost-Award Sub-committeeMembership and Operations Sub-committee

  • CoeusTwo 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 disclosuresCoeus 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.

  • CoeusCompliance Sub-committee ResponsibilitiesIRBAdverse Events (to be developed)Financial Conflict of InterestIACUC (to be developed)IBC (to be developed)

  • Coeus IRBPlanning for Coeus IRB started in FY 2003-4First 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 IRBComponents of Coeus IRBSubmission of protocols to the IRB Administrative OfficeAssignment of protocols to an IRB and specific reviewersDevelopment of IRB AgendaReview of the protocols by IRB reviewersCreation of Memos of Concerns/Approval to InvestigatorsElectronic creation of minutes

  • Coeus IRBTypes of Submissions processed by the IRBExemptionExpeditedNew Protocol (Full Committee)ContinuationsAmendmentsClosureNOTE: Processing Unexpected Event/Adverse Event is a separate module that will be developed in the future

  • KRA-CoeusCoeus is the product leader for Electronic Research AdministrationKRA started July 1, 2007KRA licensed Coeus software as the basis for all future KRA softwareKRA 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 applicationsThere is the hopes that KRA and Coeus will eventually become one product

  • Kuali Research Administration IRBFunctional Development Process

  • Kuali IRBMapping Coeus to KualiCoeus Premium & Lite

  • GoalsMaintain all functionality from the Coeus productApply development infrastructure & user interface consistent with KualiIdentify critical enhancements for consideration in Kuali product

  • KRA IRB TimelineKRA IRB will be part of Release 2Functional specs and mock screens are in progressCode 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 timeLead SME is identified. Works closely with development manager & business analystWeekly conference calls and possible, but infrequent face-to-face meeting

  • Process: Module Development StepsSMEs review current product (Coeus) functionalitySMEs write specification documentsEnhancements to FC for review/voteFC keeps tabs on scope throughoutUsability group build screen mockupsSMEs review screen mockupsDevelopers build codeTesters do quality assurance and report issues

  • ToolsCoeus test systemMock screensConference Conferencing (Breeze)Wiki (Confluence)Standard documentation templates KRA Glossary

  • Challenges: User InterfaceCoeus Premium provides tools for IRB office staff to manage protocol lifecycleCoeus Lite provides protocol submission capabilityKRA IRB provides single, consistent interface; possibility of different views for different constituents

  • Challenges: Anticipating Future DevelopmentKRA expects to build other compliance modules (e.g., IACUC and IBC)KRA IRB SME group is attempting to design generalized solutions. Examples:Committee processProtocol workflowAgendas and minutes

  • Coeus/KRA CollaborationNew development in Coeus IRB is ongoing with significant enhancements in recent releasesCoeus consortium members participate in KRA SME groupKRA SME members attend Coeus Compliance Committee meetingsTwo KRA partners currently implementing Coeus IRB

  • Keys to SuccessSolid Coeus IRB base to build onInvolvement of functional experts (SMEs)Involvement of Coeus experts (Coeus Consortium member participation)Structured Kuali processRegular meetings with regular core group participationGood working relationship between KRA and Coeus

  • Kuali Research Administration IRBThinking Ahead about KRA IRB Implementation

  • Global Implementation IssuesBuilding a quality flexible product is critical to successful implementationsMigration path for Coeus IRB usersInteroperability between Coeus and KRA components?

  • Local Implementation IssuesImplementing Coeus IRB now as step towards KRA IRBInitiating implementation planning nowNegotiating funding and resources availabilityKey KRA development players (technical and functional) will become key KRA implementation players

  • Kuali Research Administration IRBCornell KRA IRB Support Mechanisms

  • Coeus IRB ImplementationCornell-Weill Medical College has implemented Coeus IRBCornell-Ithaca is in the process of implementing Coeus IRB as an interim solution until KRA IRB is availableCornells 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 ImplementationCU KRA Steering Committee (Includes Coeus)Compliance Development/Implementation TeamsCoeus IRB Implementation TeamKRA Financial COI Development TeamKRA IACUC Development Team

  • IRB Implementation TeamFaculty Advisory CommitteeFaculty/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 ImplementationIRB Implementation TeamAsst. VP for Research ComplianceResearch Compliance CoordinatorIRB AdministratorEducation CoordinatorDirector, Research Admin Information Services (RAIS) [IRB SME Leader]RAIS Program Analysis

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