ACRIN 4703 lung 1 1): and Surveillance of Indeterminate - DECAMP 1/4703 DM...Diagnosis and Surveillance of Indeterminate ... Medidata Rave URLs you have ... Rave has the functionality to add fields/forms dynamically to a

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  • ACRIN4703DetectionofEarlylungCancerAmongMilitary

    PersonnelStudy1(DECAMP1):DiagnosisandSurveillanceofIndeterminate

    PulmonaryNodules

    DataManagementTrainingLindseyDymond,SeniorResearchAssociate

    ldymond@acr.org2157170838

  • Outline

    Registration AccessingtheACRINWebDataCenter RegisteringaPatient

    DataCollection RaveSettingupyouraccount iMedidataversusRaveEDC 4703Rave GeneralRaveEDC

  • Registration

    AccessingtheACRINWebDataCenter RegisteringaPatient

  • Registration

    UsetheA0worksheettoassesseligibility CollectsDemographicsandInclusion/ExclusionData

    AllPatientsareRegisteredthroughtheACRINWebDataCenter ThewebformmatchestheA0worksheet

  • AccessingtheACRINWebDataCenter

    Registration

  • Access 4703 Registration

  • Select ACRIN- Protocols under the ACTIVE section

  • Enter your ACRIN login and password

  • Select Your Institution

  • Scroll to bottom of page and select Continue to Main Menu

  • RegisteringaPatient

    Registration

  • DataCollection

    RaveSettingupyouraccount iMedidataversusRaveEDC eLearnings 4703 DECAMP1inRave GeneralRaveEDC

  • Rave Settingupyouraccount

  • Inordertosetupyouraccount,followtheinstructionsintheemailinvitationfrom:

    iMedidataNotification@mdsol.comCheckyourjunkemailboxifyoudonotreceiveit.Pleaseremembertheusernameandpasswordyouspecify itwillberequiredateachloginandforfutureaccesstoiMedidataandRave

  • iMedidataversusRaveEDC

  • iMedidatavs Rave

    iMedidataistheuserportal youcanaccessallMedidataRaveURLsyouhavepermissionstofromhere

    RaveistheURLwherethedatabaseisbuiltandmanaged

    YouwillalwayssigninthroughiMedidata Note:IfyouhaveanexistingCTEPIAMaccount,youcanalsosigninthroughtheCTSUportal

  • eLearnings

  • RequiredandOptionaleLearningsRequiredTheseeLearning'smustbetakeninordertogainaccesstoEDC

    Rave5.6EDCEssentialsforClinicalResearchCoordinators(~45min)

    ECOGACRINSupplementaleLearning(~10min)Optional

    DataPrivacyConsiderationsforClinicalSystems(~50min) EDCInspectionReadinessforClinicalSites(~30min)

    AccesstoassignedeLearning's

  • 4703 DECAMP1inMedidataRave

  • AfterthecaseisregisteredviatheACRINWebDataCenter SignintoiMediata usingyourusernameandpassword

    www.iMedidata.com

  • SelectRaveEDCunderACRIN4703DECAMP1fromyourlistofstudies

  • RaveEDCHomepage

  • SubjectsHomePage

  • Thissectioniswhereallfoldersavailableforthepatientcanbefound

    Thisiswherethefolder,forms,andtargetdatesarefound.

    IconKey

    AddEvent

  • IconKeyAvailableonEachPage

  • GeneralDECAMP1RaveLayout Foldersaretitledbytimepointandformtypes

    Foldersappearonthepatientpageintheordertheyshouldbecompleted

    Mostformsarecontainedinfolders Formsappearinthefoldersintheordertheyshouldbecompleted

    Folders/Formsarerolledoutaccordingtodataenteredintheexistingforms

    Forexample,themedicalhistoryformdoesnotappearintheEligibility/RegistrationvisitfolderuntilitisindicatedontheRegistrationVisitformthemedicalhistorywasobtained

  • InitialFoldersEnrollmentForms

    Containsregistration(A0)data. Allformsareread only

    EligibilityRegistrationVisit Containsformsthatshouldbecompletedthedayof

    registration PatientCompletedQuestionnaire

    Containsformsthatthepatientcompletedquestionnairedatashouldbeentered

    Biospecimen Collection Containsformsrelatedtothebiospecimen collection

    andtransmittaltothecorelab Followup 2Year

    Containsformsthatshouldbecompleted2years(+/ 6months)afterregistration

    Allformsinthefolderwillbemadeavailable1yearsafterregistration

  • EnrollmentFormsTheEnrollmentFormsFolderiswheretheenteredA0dataisavailable

    Theprimaryformisthesubjectenrollmentform.Thisformcontainsadministrativedatarelatedtoregistration(casenumber,site#,enrollmentdate,etc)

  • Clickonafoldertoseetheforms

  • EnrollmentFormsAlldataintheenrollmentformsfolderandonthesubjectenrollmentformisreadonly.Note:Ifthereisanentryerror,therevisedA0formconfirmationmustbesentintoACRINHQ

  • InitialFolders FormsEligibility/RegistrationVisitFolder

    CompletetheRegistrationVisitForm1st Ifallprotocolrequiredprocedures/assessmentsare

    completed,thecorrespondingformswillbeaddedtothefolderaftertheRegistrationVisitFormissaved

    Physicalexam,medicalhistory,concomitantmedications,pulmonaryfunctiontext/spirometry,andCTimagingforms

    Makesuretocompleteallquestionsontheform,somequestionswillappearaftertheformissaved

    Ex:Ifsputuminstructionsandsamplecollectionkitaredistributedtothepatient,thedatetheyweredistributedtothepatientwillappearaftertheformissaved

    AllFormsinthefolderarerequiredandcanbeconsideredcompletewhentheyhavetheiconNote:TheCoreLabQCformiscompletedbytheACRINimagingcorelabtechnicianandwillbereadonly

    InitialView

    AfterEntryofRegistrationVisitForm

  • InitialFolders FormsPatientCompletedQuestionnaire

    EachforminRavecorrespondstoaseparatesectionofthepaperPatientCompletedQuestionnaire

    EachsectioninthepaperformhasatitlethatcorrespondstotheforminRave

    TheRaveformshavetheoptionofpt leftfieldblankforallquestions

    Allquestionsmusthaveananswerenteredoritindicatedthept leftthefieldblank

    AscannedcopyofthecompletedquestionnaireshouldbeuploadedintoRave(ontheConclusionform)

    AllFormsinthefolderarerequiredandcanbeconsideredcompletewhentheyhavetheicon

  • InitialFolders FormsPatientCompletedQuestionnaire

  • InitialFolders FormsBiospecimen Collection

    Formsshouldbecompletedrightafterthecorrespondingbiospecimen collectionisperformed

    AllformsinthefolderarerequiredEachformhasafieldtoindicateifcollection/transmittalwasnotdone

    TheBiospecimen TransmittalFormsshouldbecompletedoncethesamplesaremailedtoBoston

    AllFormsinthefolderarerequiredandcanbeconsideredcompletewhentheyhavetheicon

  • InitialFolders FormsFollowup2Year

    Thisformisentryrestricteduntil6monthspriortothetargetdateExample:ThepatientwasregisteredSeptember20,2012,thetargetdateforcompletionofthefolderisSep20,2014.TheformwillbemadeavailablefordataentryMarch20,2014

    AllformsinthefolderarerequiredTheStudyEvaluationandDiagnosisFormmatchestheStudyEvaluationandDiagnosisworksheetMakesurethatthelogicinstructedontheworksheetisfollowedwhenitiscompleted dataentryisrestrictedtothislogic

    AllFormsinthefolderarerequiredandcanbeconsideredcompletewhentheyhavetheicon

    TargetDate(grey)

  • AddEvents AdverseEvents

    AddstheAdverseEventfolder,whichcontainstheAEformthatshouldbecompletedifareportableadverseeventoccurs

    Followup AddstheFollowupFolder,whichcontainsformsthat

    shouldbecompletedeverytimetheparticipanthaslungrelatedSOCfollowup

    ImagesSenttoCoreLab AddstheImagesSenttoCoreLabFolder,which

    containsformsrelatedtothesubmissionofalllungrelatedimagingdoneaspartofSOCfollowup

    OffStudy AddstheOffStudyForm,whichshouldbe

    completedifthepatientwithdrawalspriortostudycompletionorattheendofthestudy

  • AddEventsAdverseEvents

    TheAdverseEventfolderwillbeaddedtothetasklisteverytimetheeventisadded

    AdverseEventReporting OnlyAEsthatareconsideredpossibly,probably,ordefinitely

    relatedtothestudyrelatedbiospecimens collectionproceduresrequirereportingtoACRIN(refertoyourlocalIRBspoliciesandproceduresregardingreportingofexpectedAEs)

    RefertoSection10.0oftheProtocolformoredetailsonAdverseEventReporting

    Whenthefolderisadded,itcontainsonlytheAdverseEventForm OncetheAdverseEventFormissaved,theformnameisupdated

    withthedateoftheAE IftheAEisaseriousadverseevent,theSeriousAdverseEvent

    formwillbeaddedtothefolder

    InitialView

    Viewaftersaving

    ViewaftersavingtheAE,ifitwasmarkedasaSAE

  • AddEventsFollowup

    Thiseventshouldbeaddedeverytimethepatienthasalungrelatedfollowupvisit

    TheFollowupAddEventaddstheSOCFollowupVisitsFoldertothetasklist

    TheSOCFollowupVisitsFoldercontains2forms,theSOCFollowupFormandtheStudyEvaluationandDiagnosisForm

    ThefoldernameisupdatedwiththedateofSOCfollowupaftersubmissionoftheSOCFollowupForm

    SOCFollowupForm Ifthept hadsurgeryandsampleswerecollected,thespecimen

    transmittalformswillbeaddedtothefolderforentry StudyEvaluationandDiagnosisForm

    RaveversionoftheStudyEvaluationandDiagnosisWorksheet Theworksheetmustbecompletedbythepatientstreating

    physician,butcanbeenteredbythesiteRA

    InitialView

    ViewaftersubmissionofSOCifsurgicalspecimenswerecollected

    ViewaftersubmissionofSOC

  • AddEventsImagesSenttoCoreLab

    AllimagingthepatienthasrelatedtotheirlungSOCfollowupshouldbesubmittedtoACRIN

    Thisdoesnotincludetheimagingdonethatdeterminedeligibility,whichissubmittedintheEligibility/RegistrationVisitFolder

    Eachtimeimagingissubmitted,theImagesSenttoCoreLabeventshouldbeadded

    Thefirsttimetheeventisadded,theImagesSenttoCoreLabFolderisaddedtothetasklist,whichcontainstheImageTransmittalWorksheetandtheImagesReceivedinCoreLabForm

    ImageTransmittalWorksheet CompletedbySite ImagesReceivedinCoreLab CompletedbyACRINCoreLab

    Allsubsequentsubmissionsoftheeventaddthese2formstothesamefolder

    Theformnamesareupdatedwiththedateofimagingaftersubmission

    InitialView

    Viewaftermultiplesubmissions

  • AddEventsOffStudy

    TheOffStudyAddEventaddstheOffStudyFormtobottomofthetasklist

    Theformshouldonlybecompletedintheevent: Theprotocoldefinedfollowupiscompleted DMinstructsyouthepatientmustbetakenoffstudyduetoa

    protocolviolation Patientwithdrawalsconsent Theinvestigatordeterminesthepatientmustbetakenoff

    studyduetootherfactors,suchasadverseevents,death,etc.. Thisformmustbeelectronicallysignedbythesiteprincipal

    investigator

  • GeneralRaveEDCNavigation

  • UnknownDay/MonthRavehasthefunctionalitytoallowentryofunknowndaysandmonths

    RecordUNKforunknownmonthsandUNforunknownDays Thisfunctionalityisonlyenabledonappropriatedatefields

    MedicalHistory DateofDiagnosis ConcomitantMedications StartDate ImageTransmittalWorksheet DateofBirth

    Note:Dependentonsiteregulations,somesitesarenotallowedtoreportthedayandmonthofbirthduringregistration.Ifthisappliestoyoursite,pleaseensureyoudonotreportthedateandmonthonanyotherforms.

  • DynamicFieldsandFormsRavehasthefunctionalitytoaddfields/formsdynamicallytoaform/folder/subjectAllfieldsthattriggeradynamicfunctionareinitalicsandappearineitherblueorpurplefont

    BluefontmeansthefieldtriggersanotherfieldtoappearontheformPurplefontmeansthefieldtriggersanotherformtoappear

    Note:Purplefontmayalsomeanthatanotherfieldandfolderaretriggered

    AllFormsinthefolderarerequiredandcanbeconsideredcompletewhentheyhavetheicon

    Forexample:ThefirsttimetheEndobronchial BrushingFormisopened,onlyonequestionappears

  • DynamicFieldsandFormsInitialViewofEndobronchial BrushingForm

  • DynamicFieldsandFormsViewafter1st questionisansweredofEndobronchial BrushingForm

  • PaginatedTablesSometablesmaybeautomaticallypaginated,dependentonyoursettings.Ensurethatyouenter

    datafortheentireformbyselectingShowAllLinesatthebottomofthetableThelinesperpagearesetbytheuser(viaMyProfile).Defaultis20lines

  • QueriesQuerieswillappearwhenamandatoryfieldismissing,afieldisoutofrange,orifafieldisnotcompliantwithotherforms

    Queriesappearaftertheformissavedasaredhighlightedboxwiththeicon Thequeryviewablebelowthequestion Ifthedataisrevised,thereasonforrevisionmustbeprovided Theformwillappearwiththequeryiconuntilthequeryhasbeenresolved Theresponsefieldisnotrequiredunlessthedataiscorrectasis

    Theresponsefieldwillbegreyedoutoncethedataischanged/provided

    Ifdataiscorrectasisandaresponseisprovided,thefieldwillstillappearhighlightedinred,butwillhavetheansweredqueryicon

    QueryResponsefield ReasonforRevisionoptions

  • Questions?

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