Electronic submission process for the irb：yale univer

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1、ElectronicSubmissionProcessfortheIRB:YaleUniversityAdamSchechter,PhDCoordinator:Systems,Compliance,EducationHumanResearchProtectionProgramYaleUniversityGoalsToidentifythemainelementsoftheelectronicsubmissionprocessasitappliedtotheIRB.Todemonstratetheprocessforcreatingro

2、utingmaps,businessrules,andmeta-rules.Toshowhowaninstitution’sparticularbusinesspracticescanbedesignedintheCoeussystem.ToillustratetheYaleexperienceasanexamplethroughout.ElectronicSubmission:TheBasicsThemainpurposeofelectronicroutingistosimulateanIRB’sbusinesspracticewi

3、thpapersubmissions.Routingistheprocessofelectronicallymovingaprotocolsubmissionthroughthevariousrequiredreviewcomponentsofaninstitution.Rulesareteststhatdeterminehowthesubmissionwillberouted.InitialSwimlanesAtYale,theestablishedpapersubmissionprocessinvolvednotonlyappro

4、valfromtheHIC,butalsoapprovalfromothercommitteesandofficesexternaltotheHIC.Assuch,theseneededtobeincorporatedintotheelectronicroutingschemawhereappropriate:Example:YaleSchoolofNursing(Draft)MapsUnitHierarchyRoutingisdependentuponawell-structuredhierarchyMapsMapsaretiedt

5、oaunitEachunitcanhavemultiplemapsMapsMapsaremadeupofstopsorlevels.Stopsaremadeupofoneormoreusers.Eachleveloftheunithierarchycanhavemaps.Withinthehierarchyeachunit’sruleswillbeevaluatedandtheappropriatemapsareinsertedintotherouting.MapsUsersareplacedin“stops”ineachmap.Wi

6、thineachstop,userscanrepresentapproversoralternateapprovers.MapsMapscanutilizemultiplelevelswithinwhichstopsanduserscanbeplacedbyrequirement.MapsAndfromtheLiteside:BusinessRulesRolesthatcansetupbusinessrules:BusinessRulesMaintainer–DepartmentSystemAdministrator–Departme

7、ntApplicationAdministrator–ResearchOfficeBusinessRulesBusinessrulesarethenutsandboltsofelectronicrouting.Theyalsorepresentthevariouscomponentsoftheswimlanediagramwesawearlier.Whencreatingabusinessrule,youcanchoosefromfourtypes:NotificationsQuestionsRoutingValidationBusi

8、nessRulesNotethatFunctions,Questionnaires,andColumnscanbeusedasconditionstobuildbusinessrules:Functions:Develo