LabVantage-Register and Consent - University of Chicago and Conse… · to the participant tram...
Transcript of LabVantage-Register and Consent - University of Chicago and Conse… · to the participant tram...
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LabVantage
• NavigatingtheDatabase• RegisteringSubjects
• EnrollingSubjectsonanIRBprotocol• DocumentingConsent
Disclaimer:Printedcopiesarenottheofficialdocument.PleaseseetheonlinePDFfileforthemostup-to-dateversion.http://htrc.uchicago.edu 12/4/15
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NavigatingtheDatabase
BringsyoubacktothispageLogoff
Changepassword
Clickonanyofthetramstops toaccess thatpage
ThePI/RADashboardprovidesyouwithanoverviewofyourIRB
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RegisteringaSubject
• Gotothesubjectpage • Selectadd
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RegisteringaSubject
• Entersubject’sinformation• Yellowfieldsaremandatory• Selectsave
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RegisteringaSubject• Ifthesubjectisalready
registeredinLabVantage,thebelowerrormessagewillappear
• LabVantage requiresauniqueMRNforeachsubject,reducingthechanceofduplicatingsubjectentries
• NothingelseneedstobedoneinordertoregisterthissubjectinLabVantage
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EnrollingaSubject• After registeringasubject in
LabVantage, thenextstepistoenrollthesubjectonanIRBprotocol
• Ifanewsubjectwasentered intoLabVantage, theenrolloptionwillappearoncesaveisselected
• Simplyselectenrolltoaddthesubject toanIRBprotocol
• Entertheappropriate IRBnumberandtheenrollmentdate
• Enteringexternal IDisoptional• SelectOK Typing“n”willentertodaysdate
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EnrollingaSubject• Ifthesubjectwasalready
registered inLabVantage,returntothesubject listpagebyselecting return tolist
• Itisalsopossible toreturn tothelistpagebyselecting thesubjecttab
• Orbyreturning tothemaintramline
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EnrollingaSubject• Fromthesubjectlistpage,usethesearchoptionstofindthesubjectofinterest
• Forsimplesearches,usethesearchbyqueryoption
• Formorecomplexsearches,usetheadhocsearchoption
SearchbyQuery
AdhocSearch
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EnrollingaSubject• SearchbyQueryand
Results
Forexample,tosearchforthesubjectwithaMRNofT987654,selectMRN#fromthesearchby
queryoptionsandenterT987654intheMRN#field.SelectOK.
Thesearchwassuccessful andthesubjectwithMRNofT987654was
retrieved
Toenrollasubject,checktheboxnexttothesubjectIDandselect enroll.Gothroughthestepsofenrollingthesubject
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EnrollingaSubject• Adhoc Search
Youcancombinemultiplesearchcriteriabyclickingonthismagnifyingglass icon
Justfilloutyoursearchcriteriaandselect searchnow
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EnrollingaSubject• Adhoc SearchResults
Thesearchwassuccessfulandthecorrectparticipant
wasretrieved
Toenrollasubject,checktheboxnexttothesubject IDandselectenroll.Gothroughthestepsofenrollingthe
subject
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EnrollingaSubject• Atthispoint,thesubject’s
informationhassuccessfullybeenenteredandtheyhavebeenenrolledinanIRBprotocol
• OncethesubjectisenrolledinanIRBprotocol,theyareconsideredaparticipant ofthatIRBprotocol
• Thenextstepisdocumentingconsent
• Remember:thisstepmustbecompletedinorderfortheHTRCtocollectandprocessbiospecimens forthatparticipant!
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DocumentingConsent• Immediatelyafterenrolling
asubject,theconsenttabwillappear
• Youmustselectyes/noandthedatethatconsentwassigned
• Selectsave• Selectingsavewillpopulateyour
nameintheconsentcapturedfield
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DocumentingConsent• Alternately,youcan
documentconsentbygoingtotheparticipanttramstop
• Usethesearchoptionstofindtheparticipantofinterest
• Forsimplesearches,usethesearchbyqueryoption
• Formorecomplexsearches,usetheadhoc searchoption
SearchbyQuery
AdhocSearch
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DocumentingConsent• SearchbyQueryand
Results
Forexample,tosearchfortheparticipantwithaMRNofT987654,selectMRN#fromthesearchby
queryoptionsandenterT987654intheMRN#field.SelectOK.
Thesearchwassuccessful andtheparticipantwithMRNT987654was
retrieved
Todocument consent,clicktheboxnexttotheparticipant ID,andthenselect edit.Selectingeditwillbringuptheparticipantdetails. Fromthispage,enter
consent information
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DocumentingConsent• Adhoc Search
Youcancombinemultiplesearchcriteriabyclickingonthismagnifyingglass icon
Justfilloutyoursearchcriteriaandselect searchnow
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DocumentingConsent• Adhoc SearchResults
Thesearchwassuccessfulandthecorrectparticipant
wasretrieved
Todocument consent,clicktheboxnexttotheparticipant ID,andthenselect edit.Selectingeditwillbringuptheparticipantdetails. Fromthispage,enter
consent information
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Review• Inorder forbiospecimens tobecollectedandprocessed intheHTRC,the
followingstepsmustoccur:1. Youmusthaveanactiveservice applicationwiththeHTRC.Ifyoudonot,
[email protected]. Forbodyfluidsandresearch-onlytissue:
• Register thesubject,enrollintheappropriateIRBprotocol,anddocumentconsentpriortothesample’sarrival intheHTRC
• Email [email protected] 24hoursinadvanceofthespecimen’sarrival– Includecontact information,IRB#,patientname,patientMRN,specimentype,andtheanticipated
date/timeofarrival
• Page4512whenthespecimen isen routetotheHTRC– Includecontact information,IRB#,patientname,patientMRN,specimentype,andtheanticipated
date/timeofarrival
3. Fortissue thathasadiagnostic component:• Register thesubject,enrollintheappropriateIRBprotocol,anddocumentconsent24hours
beforethesurgicalprocedure• Forlastminutecases,pleaseemail [email protected] andpage7325
– Includecontact information,IRB#,patientname,patientMRN,specimentype,andtheanticipateddate/timeofarrival
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