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ThisRascalprotocoltemplateshouldbeutilizedwhenconductingastudythatONLYinvolvesaretrospectivechartreviewofCUMC-NYPpatientrecordsinwhichin-personinteractionwithsubjectsisnotanticipated.**Tips:

- Pleaseselect“Save”aftereachpage.- Selectthebluequestionmarkiconforguidanceonwhatisneededineachfield- Thelinksonthelefthandsideareallpagesthatneedtobecompletedpriortoresubmission.

Thelinkonthelefthandsidethatishighlighteddarkblueisthepagethatiscurrentlyaccessed.

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1) “[x]Noneoftheabove”shouldbeselected2) “[x]Yes”shouldbeselectediftheCUIRBwillbeprovidingapprovalfortheanalysisconducted

byCUresearchers.3) Ifdatafrommultiplesiteswillbetransferred/utilizedinthisresearchORifyouwillvisitexternal

sitestoobtaindata,pleaseensurethisfieldindicates,“Yes”.4) “[x]Noneoftheabove”shouldbeselectedunlessutilizinganyofthelistedUniversityresources.

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1) Completethetextfieldtoaddresstheinstructionfoundbeneatheachheader.2) Alternatively,youmayselectthe“[x]AbbreviatedSubmission”designationifastandalone

protocolprovidingthisinformationwillbeattached.

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1) Studiesthatinvolveabstractionofidentifiabledatafrompatientmedicalrecordsaregenerallynoteligibleforexemption.Thiswouldalsobethecaseifanylinkagebetweentheabstracteddataandthemedicalrecordexists.

2) StudiesthatinvolveanalysisofexistingdatafrompatientmedicalrecordsaregenerallyeligibleforExpeditedreview,category5.

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1) Describeanyfundingonthispage**Tip:

- Afullfundingapplication(facepage,budget,andnarrative)shouldbeattachedforallfederalfundingsources.

- Subcontractsitesshouldbenoted,theirFWAprovided,andasummaryoftheirroledescribed

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1) Addthelocationinwhichthedatawillbeabstractedandthelocationinwhichyouranalysiswilltakeplace.

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1) AddallCUpersonnelthatwillbeinvolvedintheabstractionofpatientdataanditssubsequentanalysis.PrincipalInvestigatorsmustbefulltimefacultymembers(Professor,AssociateProfessor,AssistantProfessor,SeniorResearchScientist/Scholar,ResearchScientist/Scholar,Instructor).

2) Ensurethatallrequiredtraininghasbeencompleted.CUMCresearchersmustcompleteHIPAATC0019andHSPTC0087traininginordertoparticipateinresearch.Theelective,ResearchwithMinorstraining,foundwithinHSPTC0087isalsorequiredifyouwillanalyzedatafromchildren/minors.Foradditionalguidance,visittheTrainingCentersectionofRascal.

3) ObtainingInformedConsentcolumnshouldindicate,“N”forallpersonnelasnointeractionwithsubjectswilltakeplace.

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1) Addallapproversthatmayberequiredperyourdepartment.**Tip:StudiesoriginatingfromaPediatricsdepartmentmustlistFionaSandersasanapprover.

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1) Pleaseensurethatthestorageselectionsforallelectronicdataareconsistentwiththestorageselectionsforsensitiveelectronicdata.Ifyourdatasecurityproceduresaresuchthattheyarenotconsistent,theinconsistencyshouldbenotedinthetextfieldfoundonthispage(e.g.,non-sensitiveelectronicdatastoredonbothendpointandsystem,sensitiveelectronicdataonlystoredonencryptedendpoint).

2) StudiesthatinvolvesabstractionofdatafrompatientmedicalrecordsgenerallyinvolvesensitivedataintheformofPHI.

3) SensitivedatastoredelectronicallymustbeeitherstoredonanencryptedendpointdeviceoronaCUMCITcertifiedmulti-usersystem.Foralistofcertifiedmulti-usersystemspleaseselectthefollowinglink:https://secure.cumc.columbia.edu/cumcit/secure/security/sap.html

4) Describehowdatawillbestored(ensureconsistencywiththeaboveselections).Explainifdatawillbestoredwithdirectidentifiersorlinkedtoidentifiersviaacode.Ifthelatter,confirmthatthekeywillbestoredseparatelyandexplainhowthiskeywillbestored.Explainifandhowdatawillbetransferredexternallyandifthistransferwillconsistofalimiteddataset.

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1) Select“Yes”totheAnalysisofexistingdataand/orprospectiverecordreviewfield.2) Select“Yes”totheFutureuseofdataand/orspecimensfieldifyouanticipateutilizingthedata

infutureresearchorifyouwilltransferthedatatoanexternalsiteandtherecipientmayutilizethedatainfutureresearch.

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1) Astudyisonlyconsideredretrospectiveif“[]Allofthedataareinexistence”atthetimeoftheprotocolsubmission.

2) Includethebeginningdateandenddateofthedatatobeanalyzed.Notethattheenddateshouldnotsurpassthedateoftheprotocolsubmissioninorderforthestudytobeconsideredretrospective.

3) Select“[]Columbiaand/orNYP”and“[]Datatobeanalyzedwereorwillbecollectedforclinicalcare”ifalldatacomefromCU/NYPmedicalrecords.

4) Select“Yes”tothefieldthatasksifamemberoftheresearchteamwillbeabstractingdatadirectlyfromsourcedocuments.Completethesubsequentlygeneratedfieldsthatasksifyounormallyhaveaccesstothedataaspartofclinicalcareorifspecialauthorizationisneeded.Ifspecialauthorizationisneeded,pleaseexplainwhatapprovalwillneedtobesoughtorattachthisapprovaltotheprotocol.

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1) Asdataareabstractedfrommedicalrecordsonly,pleaseupdatethisfieldtoindicate“N/A”.Nodatawillcomefromapriorresearchstudy.

2) Thissectionreferstothemannerinwhichdataisreceived/accessed.Aspatientmedicalrecordscontaindirectidentifiers,pleaseupdatethisfieldtoselect,“[x]Containsdirectidentifiers”.

**Tip:StudiesinvolvingaccesstopatientbillinginformationwillrequireapprovalfromtheCUBillingComplianceOfficer,DianeYaeger.Dianecanbereachedatdly2102@columbia.edu.

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1) Ifyoupreviouslyindicated,“Yes”tothefutureuseofdataontheProcedurespage,thepageabovewillbesubsequentlygenerated.Pleaseselect,“[]Data”.

2) IfyouwillretainthedataatCUMC,pleaseselect,“[]Someoralldataand/orspecimenswillberetainedbyColumbiaresearchersforfutureuse”andcompletethesubsequentlygeneratedfields.

3) Ifdatawillbereleasedexternally,pleaseselect,“[]Someoralldata/specimenswillbereleasedtoanon-ColumbiaentityforfutureuseandColumbiaresearcherswillnothavedirectcontrol.”Pleaseidentifytherecipientanddetailtheconfidentialityofthedatatransferred,aswellasthedatasecurityutilizedduringtransit.**Notethattransferofdatatoanexternalsitewilllikelyrequireexecutionofadatauseagreement.PleaseconsultwithCUSPAregardingthedevelopment/executionofadatauseagreementpriortothetransferofdata.TheIRBjustneedsthefinalexecutedversionpriortothedatatransfer.

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1) Asthisisaretrospectivechartreviewthatinvolvesnointeractionwithsubjects,pleaseupdatethissectiontoindicate,“[x]Studydoesnotinvolverecruitmentprocedures”.

2) Asthisisaretrospectivechartreviewthatinvolvesnointeractionwithsubjects,pleaseselect,“[x]Awaiverofsomeorallelementsofinformedconsentisrequested”.

3) Pleaseselect,“[x]Thisstudyqualifiesforawaiverofconsentasper45CFR46.116(d).”

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1) Pleasejustifyhoweachoftheregulatorycriteriaissatisfied.Itisnotsufficienttosimplystate,“retrospectiverecordreview”.

2) Pleaseselect,“[x]Languageofsubjectsisunknown/irrelevant”.3) Pleaseindicate,“No”tothefieldthatasksifsurrogateconsentisproposed.

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1) Pleasecompleteallfieldsfoundonthispage.Notethatitisnotsufficienttorefertoastandaloneprotocolinthesefields.Pleaseutilizethebluequestionmarkiconforinformationaboutwhatisneededineachfield.

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1) Select“[x]AbbreviatedSubmission”onlyifyouhaveaseparatestandaloneprotocolthatincludestherelevantinformation.

2) ThePotentialRiskssectionshouldincludethepotentialforabreachinconfidentiality.3) ThePotentialBenefitssectionshouldstatethatsubjectswilllikelyreceivenodirectbenefit.This

sectionmayincludepotentialbenefittofuturepopulations.

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1) Thetargetenrollmentnumbershouldreflectthenumberofsubjectsyouanticipateincludinginyouranalysis(e.g.,thenumberofpatientrecordsaccessed).

2) Onlyindicate,“Yes”tothisfieldifyouanticipatereviewingmultiplerecordstodetermineeligibilityofasubsetofthetotalrecordsaccessed.Ifyes,pleasebesurethatthetargetaccrualnumberislowerthanthetargetenrollment.

3) Pleaseincludeyouranticipateddemographics.Ifyouarenotcertainofthisinformation,pleaseindicate“100%”under‘NonSpecific’.

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1) Pleaseidentifyanyvulnerablepopulationwhosemedicalrecordswillbeutilizedinthisstudy.

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1) PleasecreateaHIPAAFormB(WaiverofAuthorization)withintheHIPAAFormsmoduleinRascal.Pleaseensurethatthejustificationprovidedforeachofthecriteriaisconsistentwithwhatisdescribedintheprotocol.Pleasealsoensurethatitem#2explicitlyindicateswhenPHIwillbedestroyed(e.g.,attheconclusionoftheresearch)andthatitem#3explicitlyindicatesthatnoreuse/disclosureofPHIwilltakeplace.

2) PleaseaccesstheHIPAAFormslinkwithinyourprotocolandattach/submittheHIPAAFormB.

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1) Select“NotifyApprovers”2) Onceallstaffhaveapproved,youwillbeabletosubmittotheIRBbyselectingthe“Submit

Protocol”link.**Tip:AccesstheProtocolOverviewpagetoensurethatthestudystatushaschangedfrom“Create”to“Submitted”.