WIXLIB

IRB Potential Gap List: KC‐IRB 4 (Slide 1 of 9)IRB GapspIRB GapspCorrespondenceKC does not allow for free text to be entered byHRPP stafft ff intoi t correspondences.dKC does not generate any correspondence based ona 118 determination.determinationKC does not allow for additional correspondenceswithout a signature and signature is pre‐populatedand cannot be customized.Correspondence cannot be modified on a "case bycase" basis.KC does not allow for a signature choice on a caseby case basis. In KC signatures are automaticallypopulated from the correspondence templateidentified by the action.actionFileMaker allows HRPP staff to choose whichsignature to include on a template in the case wherea committee chair may be absent and they need toreplace the signature with an alternate. KC does notallow signatures to be changed (or chosen) on acase by case basis.KC does not allow HRPP staff to selectcorrespondence with or without a signature(FileMaker provides greater flexibility in the use ofwatermarks).KC does not allow for QC and regeneration ofsystem generated correspondence in the event ofan error.FileMaker: HRPP staff can select which template or In FileMaker, correspondence is associated with acorrespondencedto use forf a specificifi action;iiin KC, a transactioni type; KC ‐ correspondencedisi associatedi dsingle template or correspondence is associatedwith a specific protocol action.with a specific action.

IRB Potential Gap List: KC‐IRB 4 (Slide 2 of 9)IRB GapspIRB GapspCorrespondenceKC does not allow correspondences to be added,d l t d or modifieddeleted,difi d withoutith t customtcoding.diThThereare 28 existing correspondences in HRPP existingprocesses and only 9 correspondences OOB in KC.All of these will need to be modified and additionalcorrespondencesdwillill needd tot beb generated.t dKC only allows HRPP staff to indicate specificapproval language in action comments at time ofdetermination action (not during pending action).Case Manager AssignmentKC does not have a data field for case managerwhich would allow the ability to track changes tocase manager by date, to identify the recipient ofnotices regarding the protocolprotocol, and to generatereports on case manager workloads.NotificationsNotifications cannot be modified on a case by casebasisbasis.AgendaKC ‐ agenda explanations are not associated withprotocols listed in meeting details section and notesregarding agenda explanations are not stored inprotocols.KC does not have the functionality to show datesthat a transaction was placed "in agenda” ‐including "closed", "expedited", ‐ business processrequires each transaction being associated with anagenda date.

IRB Potential Gap List: KC‐IRB 4 (Slide 3 of 9)IRB GapspIRB GapspSearch Capabilities/ReportingKC does not contain a data field for the PI's PIDnumberb nor a way tot searchh protocolst l bbasedd onPID number and display hyperlinks to theapplications.KC does not allow for consolidation of comments fora particular IRB number lookuplookup.KC does not have a Status tab (Status check: simpledisplay ‐ app type, type action, submitted, sentout, approval, letter sent, agenda date, casemanager and each "r" or "I" links to the particulartransaction; displays easy history).KC does not allow for customized searches that willprovide hyperlink to the PI form (contactinformation).KC does not allow for customized searches for anyfield (or combination of fields) on any application(initial, renewal, amendment, etc).KC does not have a Status tab.KC ddoes not allowll ffor customizedi d searchesh thath willillprovide hyperlink to reviewer form (contactinformation).FileMakerFilM k allowsllHRPP staffff to easilyil searchh ffor anddtrack all 118 projects.KC does not allow for customized searches that willprovide hyperlink to a specific record to displayindividual comments.HRPP staff can easilyy search for and identifyy PIs inFileMaker.

IRB Potential Gap List: KC‐IRB 4 (Slide 4 of 9)IRB GapspIRB GapspSearch Capabilities/ReportingFileMaker: within each PI record, HRPP staff is able PI database: unable to search for and report on allrecords ‐ all records within the databaset see allll protocolstot l theth PI isi associatedi t d withith (e.g.,(assigned as PI, Co‐PI, etc); KC ‐ display not available (hyperlinks).to the HRPP staff and they must navigate tospecific search screens.FileMaker ‐ has an "Admin" tab with the followingPI database: inability to store and link attachmentsdata fields: (comment, approval date with(hyperlinks).checkbox to select) ‐ alteration of consent, waiverof consent, waiver of documentation, pregnantwomen or fetuses, neonates, prisoner, children,wards, diminished capacity, HIPAA, FDA regulated,investigational devices (SR/NSR), sponsor‐investigator, institutional reliance agreements,individual investigator agreements,noncompliance, audit, federally funded, sites,other (KC ‐ does not have an Admin tab nor a singlelocation that collects all of this data).Ability to perform multiple searches simultaneouslyPI database: inability to link protocols.with ability to access full protocol records.

IRB Potential Gap List: KC‐IRB 4 (Slide 5 of 9)IRB GapspIRB GapspOnline ReviewKC does not allow the entry or display of reviewcommentt responses byb theth PI iinlineli withith wherehthe comments are entered by HRPP staff. PI mustrespond to comments as a note or attachment.KC does not retain the individual reviewerdetermination recommendation forapproval/disapproval in the online review tab.Online ReviewKC ‐ HRPP staff cannot view reviewer commentsuntil they are "submitted"submitted by reviewer due to thetransactional nature of the system (commentdatabase, Review tab).WatermarksKC does not allow for a real time online review andtherefore view ability/accessibility of online reviewand comments are determined only by HRPP staffaction.KC does not allow for multiple watermarks to be ona single document.KC does not permanently retain (e.g., Summary &HiHistory)) HRPP staffff iinstructions/commentsi /submitted to each reviewer (reviewer assignment).KC does not allow for watermarks to be appliedselectivelyl i l to some documentsdandd not to others.hKC does not allow HRPP staff to remove a reviewerfrom the pprotocol review, but still maintain arecord of the review assignment (e.g., if thereviewer was unable to complete review on time).KC does not allow different watermarks to be used.

IRB Potential Gap List: KC‐IRB 4 (Slide 6 of 9)IRB GapspIRB GapspData FieldReviewer CommentsKC does not capture and retain in history the date a KC does not allow for the ability to print off reviewcomments left only by HRPP staff (currently allrevieweriwas assignedi d tto a protocolt l or datad t fieldfi ldreviewer and HRPP staff comments would print offfor "follow up required“.at once for current review).KC does not allow the HRPP staff the ability toKC does not allow all of the review comments in aselectl t theth statust t optionstiforf a protocol;t l KC statust t iis consolidatedlid t d viewi withinithi ththe didisplayl off ""reviewiprogrammed to an action.comments" for each protocol.KC does not allow the business office the ability to KC does not retain the original comment left by adetermine the status options for a protocol (ability reviewer separately if it is edited by HRPP staff.to identify status types related to business needs).Shortcut KeysShortcut keys are not available in KC as they are inFileMaker.

IRB Potential Gap List: KC‐IRB 4 (Slide 7 of 9)IRB GapspIRB GapspAttachmentsKC does not allow a user (HRPP staff, PI, orreviewer)i) tto viewi attachmentstt ht associatedi t d withitheach transaction (initial app, amendment, renewal,etc). User is not able to easily discern whichattachments are uploaded for each transaction.FileMaker ‐ attachments are associated bytransaction type (I ‐ record or r ‐ record ‐ initial andrenewal/revision records); in KC, it is difficult todetermine when a document has been revised andwith what "R" or "A" record it is associated with.KC does not allow HRPP staff to upload 'other'approval documents (documents other thanapproval letter, etc) (during the approval process).FileMaker provides for the ability to view and printjust the approval docs (approval docs ‐ anydocuments that need to be provided to the PI aspart of the 'approval package').KC does not include an administrative tab (currentlyFileMaker: HRPP staff uploads attachments onlabeled HRL) where documents can be uploaded andbehalf of PI ‐ process allows the staff to QCdocuments prior to uploading into the system; KC: be made viewable to HRPP staff and/or reviewers,PI (and/or HRPP staff) uploads documents ‐ may be but not PIs (includes data elements associated tothe attachment).a labor intensive process to ensure correctdocuments were attached or uploaded by PI (QCreview).KC ‐ no separate attachmenthlocation/noli / abilitybili toupload review attachments at any point in theprotocol lifecycle (no Admin Attachments tab).KC ddoes not allowll HRPP staffff to uploadl d documentsdin the protocol or upload attachments at any time ‐regardless of the status of the protocol.

IRB Potential Gap List: KC‐IRB 4 (Slide 8 of 9)IRB GapspIRB GapspIdentifiersKC does not allow HRPP staff to assign a customuniqueiididentifiertifi ffor ththe initiali iti l application.li tiKC ddoes nott allowll ffor HRPP stafft ff tto ffree fform entertthe current location of the physical file (e.g.,specific HRPP staff member's office).HistoryKC does not allow HRPP staff to see or print historyof all review comments left over the history of anentire protocol (i.e. protocol summary report onlyshows most recent review comments) in aconsolidated view (previous or next in submissiondetails is required).118 DesignationKC system does not have the ability to apply ‘118designation’ determination to a research projectdesignation(protocol/submission status) in such a way thatcorrespondence can be generated and the protocolcan be kept by the PI for future submission.KC doesdnott allowll theth HRPP stafft ff tot includei l d orassociate an Expiration Date with the 118 project.The 118 designation process does not generate anexpiration field because the expiration date is notdi l d sincedisplayediit iis nott a fformall approvall process.HistoryKC does not provide the ability to see allcomments associated with the protocol over itsentire lifecycle or the ability to readily find whichare associated with initial application and thoseassociated with renewal/revision. In FileMaker,HRPP staff and reviewers may see uneditedcomments; however, PIs are not able to viewcomments until the record is marked as viewable.

IRB Potential Gap List: KC‐IRB 4 (Slide 9 of 9)IRB GapspIRB GapspMiscellaneousKC does not allow for real time interactionb tbetweenreviewers,iPIPI, andd HRPP stafft ff ddue tto ititstransactional nature.KC: multiple actions are often required or necessaryto produce what can be accomplished in one actionin FileMaker.FileMaker ('running banner'): information is easilytracked and displayed to HRPP staff for each recordin the system (initial app, renewal revision,comments, review): Committee, Category, Level ofReview, Title of Project, PI, Location, Status, DateSubmitted, Record Action, Last Full Review, CurrentApproval, Most Recent Action ‐ that display is notavailable in KC.In FileMaker, a PI is not able to modify the initialapplication, renewal, or revision application once itis submitted to the IRB. In KC, information can bemodified upon the ‘Return to PI’ action. Need theability to track changes within the project (e.g.,questionnaire).

GlossaryCode Table45 CFR 46.118 applies to applications to federal agencies that may involve human subjects but where definiteresearchh planslwouldld nott normallyll beb sett forthf thTypically provides values for drop‐down lists referenced by the applicationCOIConflict of InterestConfigurationSettingThe initial arrangement of parameters, code tables, etc. that determines what the application will do and howit componentsitst willill interacti ttCRMSClinical Research Management SystemEHSEnvironmental Health & SafetyHRPPHuman Research Protection ProgramIRBInstitutional Review BoardKCKuali CoeusKFSKuali Financial SystemKuali RiceKuali RiceRice, provides middleware suite of integrated productsOOIOrganization of InterestORAOffice of Regulatory AffairsPI/CO‐IPrincipal Investigator/Co‐InvestigatorSABALearning Management System to be used in Future State for IRB TrainingSAP‐ EDWSAP HR/Payroll Data contained within MSU’s Enterprise Data WarehouseSISMSU’s Student Information SystemUPIRSOUnanticipated Problems Involving Risks to Subjects or Others118 Designation36

KC-IRB 18 Online Review Process KC-IRB 10 Project Closure Process KC-IRB 19 Meeting Process KC-IRB 11 Suspension-TitiP KC-IRB 22 High Level IRB Process Termination Process KC-IRB 12 Renewal-Revision Process KC-IRB 23 Post Approval Process KC-IRB 13IRB 13 NliNoncompliance KC-IRB 24IRB 24 Pt lD l tProtocol Development-Submission Process