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CHARTER & MOU

Transcript of CHARTER & MOU - download2.eurordis.orgdownload2.eurordis.org/EMM/EMM...

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CHARTER&MOU

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2019EUROCABProgramme

EURORDIS

CABSponsors

*EURORDISCABstatus(Seal,checklist)

AgreetoanMoU

TheCHARTER(CABprinciples)

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•  ThisCharterisanexpressionofmutualintentionsandaspirations

•  TheCharterisnotlegallybinding

•  Thecollaborationisbasedonrespectandisnottokenistic

•  TheCABisrecognizedasanindependentbodyandisnotstructurallydependentonthesponsor

•  Theworkandthestructureistransparent

Principles

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•  Agendasarecooperativelydesigned

•  Thedialogueismeaningfulandofhighquality

•  CollaborationbetweenthesponsorsandtheCABistimely,whereinputcanmakeadifference

•  Confidentialityisrespectedbybothsides

•  Thecollaborationisbasedontrust

•  Allinteractionsareconsiderednon-promotional

Principles

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2019EUROCABProgramme

EURORDIS

CABSponsors

*EURORDISCABstatus(Seal,checklist)

SigntheCharter(CABprinciples)

AgreetoanMoU

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MEMOOFUNDERSTANDING

  A/Initiatorsoftheresearchproject

  B/Studydesign

•  C/Implementationofthestudy

  D/ConductoftheResearchStudy

  E/AnalysisandDisseminationofresults

  F/Financialaspectsandcommitments

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Thetitleoftheproject

Theprojectdesign,includingthetypeofpossiblecontrol

Theobjectives

Endpoints

Constraintsforparticipants

ORNOT

B.Protocoldesign

ThenumberofplannedparticipantsFeasibilityTheinclusion/exclusioncriteriaTheevaluationcriteriaInformationavailabletopatientsandwhen

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Theprojectannouncement

Writingpatientinformationdocuments

Writing/adaptingtheInformedConsentform

Thechoiceoftrialsites

ThesettingupofaData&SafetyMonitoringCommittee,including(ornot)aCABrepresentative

AdverseEvents

Discussionofpossibleinterimanalyses

ORNOT

C.Implementationoftheresearch

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Theanalysisofresults

Theevaluationofpossiblebenefits,includingthosebasedonsecondaryendpointsandQualityofLifecriteria

PRO&PROmeasures

Writingscientificpapers

Disseminationofresultstothepatientcommunity

Disseminationofresultstothegeneralpublic

Thedate(s)ofdisseminationofresultstothedifferenttargetaudiences

ORNOT

D.AnalysisandDisseminationofresults

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•  TheSponsorprovidesfinancialsupporttotheCABfor:

•  Thepublicationofaninformationleafletontheprojectinallnecessarylanguages(amount)

•  Thesettingupofawebsite(amount),aphonelinededicatedtothestudy(amount),othermeansofinformation(amount)

•  Travelexpensesfor(detailedinformation)(amount)•  Thepublicationofaleafletforthedisseminationofresults(amount)•  Other(amount)

ORNOT

E.Financialaspectsandrespectivecommitments

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Referenceforparticipantsduringstudy

Incaseofnegativeresults

Post-trialaccess

CompassionateUse

Otheraspects

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MoUCommitments…  CollaborationinSystemicSclerosisandnintedanib

!  FESCA/SSCwillannouncethestudyinitsNewsletter,onitswebsite,withreferencetothisMoU

!  FESCA/SSCwillsupporttheparticipants(membersornotofFESCA/SSC)duringthestudy

!  FESCA/SSCwillcontributetothelaydisseminationoftheresultsofthestudyevenincaseofnegativeresults

!  Future/needaMentor/Admin,theywanttomakeagenda,callmeetings,theycanfind11people,wanttogetinatanearlierstage(thanPhIII),howtonegotiatebetter

RCampAoUSSc/BI

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2019EUROCABProgramme

EURORDIS

CABSponsors

*EURORDISCABstatus(Seal,checklist)

SigntheCharter(CABprinciples)

AgreetoanMoU


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