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EHR4CR
ElectronicHealthRecordsforClinicalResearch
Deliverable1.3Evaluationofprotocolfeasibility,requirementsforclinicaltrialexecutionandseriousadverseeventreporting
Version2.0
12thAugust2014
Projectacronym:EHR4CRProjectfulltitle:ElectronicHealthRecordsforClinicalResearchGrantagreementno.:115189Budget:16millionEUROStart:01.03.2011-End:28.02.2015Website:www.ehr4cr.eu
TheEHR4CRprojectispartiallyfundedbytheIMIJUprogramme
Coordinator:
ManagingEntity:
EHR4CR
D1.3Evaluationofthepilots,initialcritiqueoftheplatform 2
Document description
Deliverable no: 1.3Deliverable title: Evaluationofprotocolfeasibility,requirementsforclinicaltrialexecutionand
seriousadverseeventreportingDescription: ThisdeliverablereportsprogressonalltaskswithinWorkpackage1,including:
• pilotsiteevaluationsoffirstscenario:protocolfeasibility;• theformaldefinitionofthefinalscenarioanditssoftwarerequirements;• progressondevelopingappropriategovernanceinstrumentsforthe
platform,servicesandusers;• indepthinterviewsurveysofseniorleveldecisionmakersonthe
acceptabilityandbenefitsoftheEHR4CRplatform.
Status: Final, Revised Version: 2.0 Date: 12thAugust2014Deadline: February2014Editors: AndreasSchmidt,DipakKalra Outputs: Type Description CommunicationVehicle
Report xx xx
xx xx xx
xx xx xx
Other xx xx
Document history Date Revision Author(s) Changes 11/3/2014 0.1 Dipak Kalra Integrating initial contributions
from all task leads 12/8/2014 2.0 Dipak Kalra Updated deliverable with revised
title, clearer relationship to the DoW
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 3
TableofContents
1 ExecutiveSummary..........................................................................................................................5
1.1 RelationshiptotheDescriptionofWork...................................................................................5
2 Pilotevaluationcriteria.....................................................................................................................7
2.1 WorkdoneforPFS.....................................................................................................................7
2.2 Challenges..................................................................................................................................8
2.3 WorkdoneforPatientRecruitment&identificationScenario(PRS)........................................9
3 ScenariosandrequirementsspecificationforClinicalTrialdataExchangeandSeriousAdverseEventReporting.....................................................................................................................................10
3.1 Introduction.............................................................................................................................10
3.2 Objectives................................................................................................................................10
3.3 Problemsbeingaddressed.......................................................................................................10
3.4 Approachandactivitiesundertaken........................................................................................11
3.5 Resultsandoutputs.................................................................................................................12
3.6 Relationshiptotherestoftheproject.....................................................................................12
3.7 Nextsteps................................................................................................................................13
4 InformationGovernance................................................................................................................14
4.1 Scopeoftheworkoninformationgovernance.......................................................................14
4.2 Objectives................................................................................................................................14
4.3 Activitiesundertaken...............................................................................................................15
4.4 Resultsandoutputs.................................................................................................................15
4.5 Relationshiptotherestoftheproject.....................................................................................15
4.6 Nextsteps................................................................................................................................15
5 Stakeholderengagementsurveyresults........................................................................................16
5.1 Background..............................................................................................................................16
5.2 Methods...................................................................................................................................16
5.3 Results.....................................................................................................................................16
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 4
5.4 ConclusionsandimplicationsforEHR4CR...............................................................................18
5.5 KeyObjectivesfor2014...........................................................................................................18
6 ListofAnnexes................................................................................................................................19
6.1 Annex1-EvaluationoftheEHR4CRProtocolFeasibilityScenario..........................................19
6.2 Annex2-EHR4CRProtocolFeasibilityQuestionnairev1........................................................19
6.3 Annex3-PFSFinalEvaluationPoster......................................................................................19
6.4 Annex4-ScenariosfortheEHR4CRPlatformandBusinessModel........................................19
6.5 Annex5-ClinicalTrialExecution&AdverseEventReportingSoftwareRequirementsSpecificationv1.0..............................................................................................................................19
6.6 Annex6-ResearchDataReuseCodeVersion1......................................................................19
6.7 Annex7-StandardOperatingRules(advanceddraft)............................................................19
6.8 Annex8-InitialrecommendationsforIGproducts................................................................19
6.9 Annex9–Stakeholdersurveyresults......................................................................................19
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 5
1 Executive Summary
ThisdeliverablereportsonprogressmadeacrossalltasksinWorkpackage1.Theoriginallyintendedfocusatthisstageoftheproject,asenvisagedintheDescriptionofWork,isevaluationoftheusemadeoftheEHR4CRplatformbythepilotsites,andthisisprovidedhereforthefirstimplementedscenario:protocolfeasibility.Theequivalentevaluationforthesecondscenario,patientidentificationandrecruitment,isinprogressandwillbereportedlater.
Theevaluationworkhasbeeninitiatedandsupportedthroughadedicated“Task1.5team”.TheteamprimaryfocuswastodevelopevaluationprotocolsfortheProtocolFeasibilityScenario(PFS)andthePRS(PatientRecruitmentScenario),andtocoordinatetheexecutionofactivitiesrequiredtogeneratethedataneededaspertheevaluationprotocols.Unanticipatedissues,mainlyduetoresourcesavailability,havesurfacedduringtheplanningandtheexecutionphases.Technicalissueshavebeenencounteredaswell.Sofarthedeviationfromplanisminimal.
TheiterativeandstepwisedevelopmentoftheplatformmeansthatduringthisyearWP1hasalsooverseentheformalisationofthefinalcombinedscenarioforclinicaltrialdataexchange(withEHRs)andseriousadverseeventreporting.D1.3thereforecontainsthescenariodescriptionandtheSoftwareRequirementsSpecification,thelatterbeingtheformalhandoverdocumenttoWorkpackageGroup2whichimplementsthespecifiedplatformfeaturesandservices.
Theconsortiumisnowpreparingforthesustainabilityoftheseservices,whichisdescribedinmoredetailinDeliverable2.3.Animportantaspectofscalingupandwide-scaleacceptanceisgovernance.Thisdeliverablealsooutlinestheapproachthathasbeentakenforwardthisyearondevelopinginstruments(codesofpractice,standardoperatingrules)thatcanbeevaluatedbyourexistingpilotsitesandwillbeusedtoassuretheprocessforsigningupadditionalhospitalsasdataproviders,andresearchsponsorsasusersofEHR4CR,duringthefourthandproposedfifthprojectyear.Theworkingversionsofsomekeyinstrumentsareincludedinthisdeliverable.
Finally,andimportantly,thisdeliverablereportstheresultsofaninterviewsurveyofseniorleveldecisionmakersinhospitals,publicbodies,patientassociationsandministries.ThissurveyhasexaminedtheattitudestoEHR4CR,perceivedbenefitsandacceptanceofourapproachtopatientprivacy(tocomplementandextendtheresultsofoure-surveyundertakeninyear1).
Thisdeliverableprovidesshortprogresssummariesonalloftheaboveareas,andprovidestheactualresultsasAnnexes:thesearetheactualdocumentsthathavebeenusedbytheprojectduringtheyearasformalisedresultsoradvanceddrafts.
1.1 Relationship to the Description of Work
IntheoriginalDoWamorewaterfallplatformdevelopmentmethodologywasforeseen,andatthisstageoftheprojectitwasexpectedthatWorkpackage1wouldbefocusingontheevaluationoftheplatforminthepilotsites.Inpractice,thedesignandimplementationofeachofthescenarioshasbeenprogressedasindependentcycles:thishasbeenhelpfulinenablingtheprojecttoexperiencethefullcycleforProtocolFeasibilityandusingthelessonslearnedfordownstreamscenarios.Itshouldalsobeennotedthattherequirementsanalysesandthesubsequentplatformimplementationforthisfirstscenariohastakenlongerthanexpected,duringyears1and2oftheproject.Asa
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 6
consequence,Workpackage1,andthisdeliverable,isreportingtheevaluationundertakenoftheProtocolFeasibilitydeployment(Section2ofthisreport)andalsoreportingprogressindevelopingtheSoftwareRequirementsSpecificationforClinicalTrialdataExchangeandSeriousAdverseEventReporting.Progressondevelopinginstrumentstosupportinformationgovernance,andananalysisofkeystakeholderopinionsoftheEHR4CRapproach,arealsoreportedhere.TheseareasofprogressareinlinewiththetasksofWorkpackage1,althoughwerenotspecificallycontractedtobeprovidedinthisdeliverable.
ThecontributionstothisdeliverablefromeachoftheWP1tasksareshowninthetablebelow.
Workpackage1Tasks SpecificactivityinYear3,reportedinD1.3Task1.2StakeholderNeeds,Opportunities,&Challenges
InterviewsurveysofseniorleveldecisionmakersontheacceptabilityandbenefitsoftheEHR4CRplatform
Task1.2SpecificScenariosfortheEHR4CRPlatformandBusinessModel
ThesetwotaskshaveworkedtogetherontheformaldefinitionofthefinalscenarioanditssoftwarerequirementsTask1.3Requirements
Task1.4GovernanceSuccessFactors Developingappropriategovernanceinstrumentsfortheplatform,servicesandusers
Task1.5EvaluationofthePilots Pilotsiteevaluationsoffirstscenario:protocolfeasibility
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 7
2 Pilot evaluation criteria
AdedicatedteamwasformedtoconductactivitiesrelatedtoTask1.5-EvaluationoftheDemonstrationPilots.
TheteamprimaryfocuswastodevelopevaluationprotocolsfortheProtocolFeasibilityScenario(PFS)andthePRS(PatientRecruitmentScenario),andtocoordinatetheexecutionofactivitiesrequiredtogeneratethedataneededaspertheevaluationprotocols.
Unanticipatedissues,mainlyduetoresourcesavailability,havesurfacedduringtheplanningandtheexecutionphases.Technicalissueshavebeenencounteredaswell.Sofarthedeviationfromplanisminimal.
Someproblemshavebeensuccessfullyaddressedwhileothershavepreventedthetimelycompletionoftheprotocols.Theactivitiesareon-goingandareexpectedtobecompletedduring2014.
Thenumberofparticipatingsiteswasdefinedbythelistofstudyprotocolsqualifiedfortheevaluation.ProtocolsinclusionsandexclusionscriteriawerenormalizedandprogrammedonthelocalsiteEHRsdatawarehouses.
ThelistofprotocolswasprovidedbyWP7(Pilots).
Adedicatedevaluationprotocolhasbeendevelopedtodocumenttheevaluationcriteria.Aninvestigatorquestionnairewasdevelopedtocollectestimatedenrolmentthroughlegacypractices.
AnadditionalpilotisconsideredforPFSandPRStofullyexploreotherareasleftunaddressed.
2.1 Work done for PFS
Anacceptableandrobustmethodforconductingevaluationworkhasbeendeveloped.
Anevaluationprotocolhasbeendeveloped,withaprimaryfocusondemonstratingtheaccuracyofthenumbersproducedusingEHR4CRplatform.ThesecondaryobjectivewastoevaluatethetimesavedusingEHR4CRplatform.
Anevaluationprotocolentitled“EvaluationoftheEHR4CRProtocolFeasibilityScenario”hasbeenproducedandisattachedtothisdocumentasAnnex1.
Theactualexecutionoftheplannedprocedureswasconductedincoordinationwiththeworkpackage7(WP7).
Thefollowingachievementshavebeendeliveredduringtheyear2013.
- InitiationofTask1.5,includingteamformation.- ProductionoftheevaluationprotocolforthePFS- Productionoftheinvestigatorquestionnairetosupporttheexecutionoftheevaluation
protocolAnnex2.
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 8
- ApostersummarizingtheevaluationofthePFSwasdemonstratedattheannualmeetinginBerlin–Annex3.
2.2 Challenges
Somechallengeswerefacedduringthedevelopmentandtheexecutionoftheplan.
Someoverlapsofactivitiesandresponsibilitiesbetweenthetask1.5teamandtheWP7team,havebeenaddressedandresolved.IthasbeenagreedtofocusTask1.5effortonthedevelopmentoftheevaluationprotocolsandsupportivedocuments.TheactualexecutionoftheactivitiesrequirestoconducttheevaluationshavebeendefinedasbeingoftheresponsibilityoftheWP7.
TheneedforaclosecoordinationwithWP2,tomanagetheexpectationsintermofplatformavailabilityandaccessibilitywasidentifiedascritical.Actionshavebeentakentoimproveandsecureadequatecoordinationandcirculationofthestatusupdateacrossimpactedteams.TheneedsfromTask1.5teamandfromWP7havebeenincorporatedintotheWP2workingplan.
Finally,anunanticipatedissuerequiresbecorrectlyassessingandaddressed.Theexecutionoftheevaluationproceduresattheclinicalsitesgeneratesasignificantworkload.AsaresultthecompletionoftheevaluationprocedureshastakenmoretimethaninitiallyanticipatedandisnowexpectedtobefullycompleteduringQ12014.TheworkloadandstaffavailabilityatthesitewillbeassessedforupcomingPilotevaluationactivities.
BelowisasummaryofspecificchallengesspecifictothePFSevaluationproceduresthatwereaddressed.
- Selectionoftrials:10studiesusedfortheProofOfConcept(POC)oftheEHR4CRProtocol
FeasibilityScenariowereincludedintheevaluation.
- Goldstandard:abaselinevaluewasdefinedasthevalueproducedusingamanualcheckof
patientrecord–thisvaluehasbeendefinedasthe“GoldStandard”.Togetthisvalueimplies
themanualcheckofpatientrecords,100randomsubjectspertrial(withthepossibilitytouse
thesame100recordsfortrialswiththesamescope/disease).Thistaskwillbeperformedby
thePrincipalInvestigators(PIs)ormedicalexpertsatthesite.
- EstimationofthePrincipalInvestigators:Astandardquestionnaireformhasbeenproduced
(Annex2)andcustomizedbyeachindividualEFPIAmemberstomatchtheirprotocolsand
weresenttothePrincipalInvestigatorsinvolvedattheparticipatingsite.Thisprovidedthe
figuresresponsesusingthetraditionalfeasibilityprocess.
- SiteEthicalCommittee’sApproval,eachparticipatingsitehasmanagedtheprocesstoobtain
thenecessaryinternalapprovals.TheHôpitalUniversitairedeGeneve(HUG)hasrequested
tobeprovidedwithasubmissionpackagetogaintheirlocalapprovaltoproceed.Thisis
underdevelopmentandwillbeavailableforthenextiterationorevaluationprotocol.
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 9
2.3 Work done for Patient Recruitment & identification Scenario (PRS)
AfirstdraftoftheevaluationprotocolhasbeendevelopedduringQ42013.ItisexpectedtohavethefinalprotocolduringQ12014.ThedevelopmentoftheplatformforthePRS,hastakenmoretimethaninitiallyplanned. It isnowscheduledtobeavailableduringQ12014.Theevaluationprotocolisbeingdevelopedtomeetthesiteethicscommitteerequirementsandwillserve toobtain thenecessary internalapproval toconduct theevaluationprocedures.Thiswork isbeingdoneinveryclosecollaborationwithWP7.AdetailedstatusreportonthisevaluationwillbeprovidedinDeliverable1.4.
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 10
3 Scenarios and requirements specification for Clinical Trial data Exchange and Serious Adverse Event Reporting
3.1 Introduction A well conducted requirements gathering and analysis process is an important first step in thedevelopment of a usable and efficient application. This process consolidates all needs, constraintsandrequirementsinastructuredwaywithinscenarioandsoftwarerequirementsspecification(SRS)documents.
FourclinicalresearchscenarioshavebeendefinedwithinthescopeofthisprojectandprioritizedbytheExecutiveCommittee:
1. Clinicalprotocolfeasibility2. Patientidentificationandrecruitment3. Clinicaltrialexecution4. Adverseeventreporting
During Year 3we have completed the scenario and requirements definition for Clinical Trial DataExchangeandforAdverseEventReportingandthisformsthefocusofDeliverable1.2
3.2 Objectives • DefineoperationalscenariosforthedomainofClinicalTrialdataExchangeandAdverseEvent
Reporting• Definesystem(platform)requirementsbasedonoperationalscenarios,stakeholderinputs,and
inputsfromstaffatthepilotsites• Developusecasesandworkflowstoelaboratetherequirementsandsteerthedevelopmentof
toolsandservices• Finalisationoftheclinicaltrialexecutionsoftwarerequirementsspecification• Finalisationofsubjectidentificationandrecruitmentsoftwarerequirementsspecification
3.3 Problems being addressed Theinefficienciesoftoday’sseparatedprocessforcaptureofpatientcareandclinicaltrialdataareobviousattheclinicaltrialinterface.Itisestimatedthatasmuchas40%ofclinicaltrialdataareenteredintoboththepatient’shealthrecord,theclinicaltrialEDCsystem(and,possibly,athirdpapercopy)1,butthereisevenaperceptionbyclinicalstaffthatthisismorethan70%2.
Thisdividedenvironmentresultsin:
• Cumbersomeandslowprocesses
1IntegratingElectronicHealthRecordsandClinicalTrials:AnExaminationofPragmaticIssues,MichaelKahn,UniversityofColorado2EDCSiteSurvey:InvestigationalSitePerspectivesonClinicalTrialInformationSystems,eClinicalForum2009.Availableat:www.eclinicalforum.org(accessedDecember1,2011).
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 11
• Redundantdataentry• Transcriptioninconsistencies• Sourceissues
Theabilitytoexchangedatabetweenhealthcareandresearchdatabaseswould…
• Reduceredundantdataentrybypre-populatingeCRFswithdataalreadyheldwithinthelocalEHR
• Avoiddatatranscriptionerrorsrelatedtomanualtranscriptionerrorsthatcostsiteandsponsorstafftimeandefforttodetectandresolve
• Clarifythe‘source’issuebyknowingthereliabilityofsourcedata• IncreaseClinicalTrialefficiencyleadingtohigherinvolvementoftreatingphysiciansin
ClinicalTrialssastheirdailyworkislessnegativelyimpacted
AdrugadverseeventoccurringinaclinicaltrialtodayfrequentlytriggersaseparatemanualprocessfromdatacaptureintoresearchEDCsystems.AlthoughseveralcompaniesandEDCvendorshavemadeinroadsintostreamliningtheprocessbyenteringadverseeventdatawithintheEDCtoolratherthanviaaseparatepaperform,amoreefficientprocesswouldcapturedatabydirectlyconnectingtothelocalEHRsystem.Suchanapproachwillenhancecompleteness,qualityofdata,timelinessandregulatorycompliance.
3.4 Approach and activities undertaken TherequirementsengineeringprocessadoptedwithinEHR4CRprovidesamethodologyforthethoroughexaminationoftheenvisagedoperationalenvironmentandspecificationofapplicationfunctionalitiesandbehaviours.Thefollowingactivitieshavebeenundertaken:
• Interviewswithexpertsfrompharma,healthcare,academia,EHRvendorsandResearchEDCvendorstodevelopacomprehensiveunderstandingofthecurrentprocessforclinicaltrialdataexchange,userissuesandneeds
• CompilationofRequirementsScenariosfortheClinicalTrialDataExchangedomain• ConceptualmodellingoftheClinicalTrialDataExchangedomainscenarios(UMLusecase
diagramsanddescriptions)• BrainstormingandRequirementsElicitationWorkshopsinBasel(18.03.2013-19.03.2013)and
Leverkusen(27.05.2013-29.05.2013)withprojectmembersrepresentingusergroups• CompilationoftheSoftwareRequirementsSpecification(SRS)andtheirreviewand
improvementwithinWP1o iterativeandincrementalrequirementsengineeringapproacho amendmentofclinicaltrialexecutionspecificationo identificationofworkshopparticipantsbasedonskillsetso identificationofend-usersandactorsinvolvedinclinicaltrialexecution
• Releaseoftheinformalcapabilitiesdescriptionatthe08/05/13
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 12
• RequirementselicitationandanalysisworkshopforclinicaltrialexecutioninLeverkusenfrom27/05/13until29/05/13
• EDCdataintegrationworkshopinLeverkusenfrom11/06/13until13/06/13• Reviewcyclesforclinicaltrialexecution
o 1streviewcyclefrom08/07/13until22/08/13o 2ndreviewcyclefrom22/08/13until13/09/13
• Releaseoftheclinicaltrialexecutionsoftwarerequirementsspecificationat08/10/13o preparationofStageGateandStakeholderAwarenessSession(18/11/13)inBerlin
• StageGateProcess:RequirementsFreeze
3.5 Results and outputs ThemainoutputsofTasks1.2and1.3comprise:
1. ScenariosfortheEHR4CRPlatformandBusinessModel(Annex4)containingrelevantdomainandusagescenariodescriptions.
2. ClinicalTrialExecution&AdverseEventReportingSoftwareRequirementsSpecificationv1.0(Annex5)containingthefollowinginformation:
• Tools,methodsandapproach• Adescriptionandresponsibilitiesofthekeyactors/roles• Usecasesthatspecifytheenvisagedinteractionofactorswithcomponentsofthe
envisagedsystemo Identified28practicalusecasesandrequirementsforsubjectidentificationand
recruitmento GUIMock-upstodemonstrateenvisagedfunctionalityofthesoftware
• Clinicaltrialreportingfunctionalitybasedonastate-diagramonpatientstatesinaclinicalstudy(patientidentificationandrecruitmentphase),basedonsurveywithEFPIApartners
• Functionalrequirements• Non-functionalrequirements(processandqualityfactors)• DataRequirements
3.6 Relationship to the rest of the project Therequirementsscenariosandspecificationsprovideinputfor:
• Technicalworkpackagemembers,whowilltranslatetheusecasesandrequirementsintoasoftwaresystem.
• Pilotworkpackagemembers,whowillusetheSRSfortheuseandevaluationofthedevelopedsoftware.
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 13
3.7 Next steps Plannednextsteps:
• Publicationoftherequirementsengineeringprocess• Changecontrol• Nextiterationphaseforrefinementofrequirementsduringthepilotstestphaseforall
scenarios• Consolidationandupdateofscenariosintoafinaldeliverable,baseduponfeedbackduring
developmentandpiloting.• Publicationofallrequirements
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 14
4 Information Governance
4.1 Scope of the work on information governance ThroughouttheIMIaneedforacoordinatedapproachtoaddressdataprotectionconcernsbecamemoreandmoreevidentduring2013.ThereforeuponinitiativeoftheEHR4CRmanagingentity(the“convergence initiative”) a number of projects from DG Connect and IMI widely agreed to tacklesome common challenges together. One of the key questions regarding “secondary use of healthdata” was taken up by Anne Bahr (Sanofi) and integrated in the work of EHR4CR, where it waspursuedwith the contributionof TMF (Germany). A “code for secondaryuseofhealthdata”wasinitiated.FollowingcontactswiththeEuropeanDataProtectionSupervisorofficeitwasdeterminedthattheycouldprovideaformaladvicetoanEUbodyoragencysuchasIMI.ActionforIMI:supportthereviewbyhighlevelexpertsandsubmittotheEuropeanDataProtectionofficeforformalreview.
During the preparation of the pilotswithin EHR4CR, it has also become evident, that the EHR4CRProjectneedsarangeofpolicydocumentswhichlaydownhowtheEHR4CRPlatformwilloperateinpractice,coveringbothwhatisexpectedfromtheparticipatingsponsorsandhospitalsaswellastheProjectitselfandhowthiswillbecontrolledorenforced.
TheExecutiveCommitteeofEHR4CRhasthenrecognised,thatitisappropriatetobringtogethervariousstrandsofwork[noterelevantWPsanddeliverables]underan‘InformationGovernanceTaskForce’whichwillreviewlegalandsystemrequirementsandhowtheseneedtooperatewithorganisationalpoliciesandproceduresunderaframeworkofcontractsoragreementstoensuresafeandeffectiveuseofsensitivepersonalinformation,ensuringlegalandethicalconformancebytheEHR4CRInstituteandallparticipatingentities.
TheIG-TFisledbyPeterSingleton,AnneBahrandIreneSchlünderandchairedbyProf.DipakKalra,whowillalsoactastheSeniorInformationRiskOfficer(SIRO)onbehalfoftheEHR4CRproject.Thefirstproductfromthetaskforcewillbeadocument,‘EHR4CRStandardOperatingRules’whichwilllayoutpreciserulesfortheoveralloperationintermsofsystemrequirementsandorganisationaloperations.Oncecompletethensubsidiarypolicyandproceduredocumentscanbeidentified.Theproceduraldocumentsmaybeproducedastemplatesforcustomisationtothepreciseneedsofparticularorganisations,reflectingtheirrelationshipswithotherparticipatingentities.Similarly,templates(orheadsofagreement)maybeproducedtoidentifykeyaspectsthatneedtobeincorporatedinformalcontractsoragreementsbetweenparticipatingpartnersintheirdifferingroles.
4.2 Objectives • Thedocuments–andcontractsderivedfromthem-willserveasabasisformutualtrustduring
thepilotphase.• Fromthesedocuments,appropriateprocessesandprocedurescanbedeveloped,eitherwithin
thePlatform,asexemplartemplatesbytheprojectforotherstouse,orbyotherstofitwiththeirownparticularcircumstances,butinaccordancewithestablishedpolicies.
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 15
• ThedocumentswillthenalsoserveasaninformationgovernanceframeworkofthefutureEHR4CRInstituteandsupportseveralservicesoftheInstitutee.g.accreditationandcertificationservices.
4.3 Activities undertaken Themainactivitiesundertakenduring2013havebeentoworkontheCodeforReuseandtheStandardOperatingRules,andtoprovidesupporttoWP7onthedevelopmentofagenericprotocolthatmaybeusedbyhospitalswhenrequestingconnectiontotheEHR4CRplatform.Thefollowingworkshopshavealsobeenheld:
• TheConvergenceworkshop–Brussels20thand21stMarch2013• Audit&Monitoringworkshop–London11thFebruary2014• StandardOperatingRulesReviewWorkshop–London12thFebruary2014
4.4 Results and outputs Themainoutputscomprise:
1. TheResearchDataReuseCodeVersion1(firstversionsharedwithinIMIforrevision,Annex6)
2. TheStandardOperatingRulesversion0.9(advanceddraft,Annex7)3. InitialrecommendationsforIGproducts(Annex8)4. InformationGovernance(Framework)–advisorypapertoExCo(internaldocument)
4.5 Relationship to the rest of the project Thedocumentsprovideinputfor:
• Technicalworkpackagemembers,whowillreassurethatthedevelopedsoftwaresystemisinaccordancewiththerulesandpolicies.
• Pilotworkpackagemembers,whowillusethedocumentsasbasisformutualtrustduringthepilotphase.
4.6 Next steps Plannednextsteps:
• AdoptingtheCodeofConductthroughoutIMIProjects• InternalrevisionandimprovementoftheSORs• Developingcontractualobligationforparticipantsofpilotsasneeded• DevelopmentofStandardOperatingProcedures
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 16
5 Stakeholder engagement survey results
5.1 Background Theobjectiveofthistaskactivityistodetermineanddocumenttheconcerns,needs,opportunitiesandperceivedchallengesofthecomplexnetworkofstakeholdersimpactedbyEHR4CR.Therealitiesandcomplexitiesoflocal,nationalandinternationalcontextswillbeanalysedtoidentifykeyopportunitiesandbarrierstoprogress.IncentivesanddisincentivesforparticipationbyeachstakeholderinboththeEHR4CRdevelopmentstageandthelong-termsustainabilityplatformwillbeidentifiedanddocumented.
MaterialsfortheconductofstructuredinterviewswithseniorfiguresinhealthcareorganisationsacrossEurope(includingmanagersandinformationgovernancestaff,academics,clinicalopinionleaders,ethicistsandresearchfunders)weredevelopedbasedondetailedinterviewsconductedinapilotstudyinScotland.InterviewsfortheStakeholderEngagementsurveywereconductedbyseniormembersofWPG7staffwiththeaimofinterviewingkeypeopleintheirowngeographicarea.Theinterviewswereconductedinthesecondhalfof2012andthefirsthalfof2013.
5.2 Methods Atotalof37structuredinterviewswereconductedinGermany,theUK,SwitzerlandandFrance(Tables1and2).Theintervieweeswereprovidedwithadescriptionoftheprojectandstructuredinterviewswereconducted,initiallyfocussingonthefourprojectobjectives(trialfeasibility,facilitatingrecruitment,facilitatingclinicaltrialdeliveryandreportingofadverseofevents).Withineachobjectiveaseriesofscenarioswerepresentedandspecificquestionsposed.Inaddition,aseriesofquestionswereposedrelatingtoa)motivatingfactorsforahospital/academictoparticipateintrialsusingtheproposedEHR4CRplatformandb)threatsandchallengestothesuccessofanEHR4CRplatformtosupporttrials.Finally,intervieweeswereaskedtogivetheiroverallimpressionoftheEHR4CRproject.
5.3 Results PleaserefertothedetailedresultsinAnnex9ofthisdeliverable.
Clinicaltrialfeasibility:AclearmajorityofintervieweesdidnotfeeltherewasarequirementforpriorpatientconsentforuseofanEHR4CRplatformthatpermittedqueriestoberunonlocalhospitaldatawarehouses,returningcountsofpotentiallyeligiblepatientforaspecifictrial.However,asignificantnumberofrespondersthoughtthatpriorconsentwouldberequiredforthereturnofde-identifiedindividualpatientlevelinformationtothepartyinitiatingthequeryortoatrustedthirdparty.(Figures1-4)
Similarresponseswereobtainedwhentheintervieweeswereaskedabouthealthcareinstitutionalapprovalconcernsinrelationtotheproposedscenarios(Figures5-8)andtoinformationgovernanceconcerns(Figures9-12)withparticularlystrongconcernsaboutanytransferofindividualpatientdatatothirdparties.IntervieweeswereunanimousthatAnEHR4CRplatformapproachtoassessing
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 17
feasibilitywouldenhancetheconductofclinicaltrials(Figure13)andaclearmajorityofrespondersindicatedthatthisapproachwouldreduceworkloadsintheassessmentofclinicaltrialfeasibility(Figure14).
FacilitatingRecruitmenttoTrials:Thisscenarioassumes,onceatrialhadbeeninitiatedandaclinicaltrialcontractexistedwiththehealthcareorganisationsinvolved,thattheEHR4CRplatformwouldbeusedtoprovidethelocalclinicaltrialinvestigatorwithalistofpotentiallyeligiblepatientsforthetrial.Approximately50%ofrespondersthoughtthatthisapproachmightneedpriorpatientconsenttousetheirdatainthisway(Figure15).Similarnumbersthoughtthatspecificdataprotectionorregulatorybodyapprovalwouldberequired(Figure16).Approximately70%thoughtthatthisapproachwouldbeapprovedbyhealthcareorganisationsintheircountryandaclearmajoritythoughtthatthisapproachtofacilitatingrecruitmentwouldenhancetheconductoftrials(Figures18(ethicscommitteeresponders),20(non-ethicsresponders)).However,approximately50%ofrespondersthoughtthatthisapproachwouldcreateeitherethicsorinformationgovernanceconcernsintheircountry.
FacilitatingClinicalTrialDelivery:Thisscenarioassumesthatatrialhasbeeninitiatedataclinicalsiteandthatpatientshavebeenrecruitedandhavegiveninformedconsenttoallstudyproceduresanduseoftheirelectronicpatientrecordswithinthetrial.ThescenarioproposedwasthattheEHR4CRplatformwouldbeusedtoextractpre-specifieddatafromthepatients’electronichealthrecordsandpotentiallyreturnadditionaldatacollectedinthecontextofthetrialtothepatients’records.Approximately70%ofrespondersthoughtthatthisapproachtodataextractionwouldreceivehealthcareinstitutionalapprovalandsimilarnumbersthoughtthatthiswouldnotraiseinformationgovernance/ethicalconcerns(Figures21,23).Aclearmajorityofrespondersthoughtthatthisapproachwouldenhancetheconductoftrials(Figures22,24).
Whenaskedaboutthereturnofclinicaltrialdatatothepatientrecord,50%(70%)respondedthatthiswouldreceiveethics(institutional)approval(Figures25,26).Morethan65%ofrespondersthoughtthattherewasadangerthatdatafromtrialthathadbeenaddedtothepatientrecordcouldleadtomisunderstandings.However,mostthoughtthatconcernswouldbereducediftheadditionaldatawerekeptseparatefromtheusualpatientrecord(Figures27,28).
FacilitatingAdverseEventReporting:ThiscontextconsideredtwoscenariosthatwouldpotentiallyinvolvetheuseoftheEHR4CRplatform,firstlytheautomaticreportingofadverseeventswithinthecontextofaclinicaltrialwithassociatedinformedconsentandsecondlythereportingofadversedrugreactionsinapost-marketingcontext.
Inthefirstscenario,only50%wereconfidentthatthiswouldreceiveethicalapprovalwithsimilarnumbersindicatingthatthisapproachwouldraiseinformationgovernanceconcerns.However,themajorityofrespondersthoughtthatthisapproachcouldenhanceadverseeventreportingandevaluationofthesafetyofmedicines(Figures29-31).
Forthescenarioofpostmarketingsurveillance,although60%ofrespondersthoughtthiswouldreceiveinstitutionalapproval,similarnumbersthoughtthatpriorpatientconsentwouldberequiredandthattherewouldbesignificantethical/informationgovernanceconcerns.Mostrespondersindicatedthatdataprotectionorotherexternalapprovalswouldberequiredfortheadoptionofthisapproach(Figures32,33).
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D1.3Evaluationofthepilots,initialcritiqueoftheplatform 18
FactorsmotivatingfutureparticipationinanEHR4CRplatform:ThestrongestmotivatingfactorsforfutureparticipationinanEHR4CRplatformwereincomegenerationfromindustrytrials,providingpatientswithfasteraccesstonovelmedicines,stimulusforthedevelopmentoflocalhealthinformationsystemsandimprovedqualityofhealthcaredata,potentialtousetheplatformforacademicstudies,improvementinthequalityandefficiencyoftrials(Figures34-37).
PotentialthreattothesuccessofEHR4CR:ThebiggestthreatsraisedtothesuccessofEHR4CRwere,theinadequacyoflocalhealthinformationsystemsandormissingkeydataitems,thecostofupgradingsystemsandethical,dataprotectionandinformationgovernanceconcerns.Respondersweresplitontheimportanceofhospitalmanagementconcernsandtheconcernsofpatientsandclinicians(Figures38-42).
OverallsupportfortheobjectivesofEHR4CR:ThevastmajorityofrespondersagreedorstronglyagreedwiththeoverallobjectivesofEHR4CR(Figure44).
5.4 Conclusions and implications for EHR4CR TherewasclearsupportfortheoverallobjectivesofEHR4CRandabeliefthatawelldevelopedEHR4CRplatformwouldreduceworkloadsandimprovetheconductandqualityoftrials.However,theintervieweesdidraisesomeethicalandinformationgovernanceconcernsandthreatstothepotentialsuccessofanEHR4CRplatformthatwillhelpguidethefinaldevelopmentoftheplatformandalsopointtoareaswherethereisaneedtoclarifyandemphasisedatasecurity,privacyandinformationgovernanceissuesintheroll-outoftheplatform.
5.5 Key Objectives for 2014 i) PublicationoftheresultsoftheinitialStakeholderEngagementSurveyii) DesignanddeliveryofaRegulatoryStakeholderSurvey
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6 List of Annexes
6.1 Annex 1 - Evaluation of the EHR4CR Protocol Feasibility Scenario
12pages
6.2 Annex 2 - EHR4CR Protocol Feasibility Questionnaire v1
2pages
6.3 Annex 3 - PFS Final Evaluation Poster
1page
6.4 Annex 4 - Scenarios for the EHR4CR Platform and Business Model
40pages
6.5 Annex 5 - Clinical Trial Execution & Adverse Event Reporting Software Requirements Specification v1.0
45pages
6.6 Annex 6 - Research Data Reuse Code Version 1
22pages
6.7 Annex 7 - Standard Operating Rules (advanced draft)
37pages
6.8 Annex 8 - Initial recommendations for IG products
3pages
6.9 Annex 9 – Stakeholder survey results
31pages
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