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V25.12.20
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,[email protected].
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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”.