core reference - one year on€¦ · • core reference text with explanatory comments –...

COREReference-OneYearOnClarityandOpennessinRepor6ng:E3-based

SamHamiltonandTracyFarrowfor

5thEMWASymposium04May2017TransparencyandDisclosureofClinicalRegulatoryDocumentaFon

BasedonyourcurrentunderstandingofCOREReference,howusefuldoyouthinkitwouldbeinpreparingCSRsfitforpublicdisclosure?

A.  ExtremelyusefulB.  SomewhatusefulC.  NotatallusefulD.  Notsure

[quesFontoaudiencebeforepresentaFon]

A. B. C. D.

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COREReference&Disclosure1.COREReference–  Preface(21pages,references+assumpFons,including“publicdisclosure”)

–  Mainbodytext(103pages)•  ICH(E3and2012Q&A)guidancetext•  EUandUSregionalguidancesincluding“publicdisclosure”•  COREReferencetextwithexplanatorycomments

–  Including“publicdisclosure”awarenesscomments:colour-codedPPDandCCI

2.Mappingdocument–  ICHE3 COREReferencesecFonalstructure3.ExplanaFonandelaboraFonpaperincluding“publicdisclosureHamiltonS,etalResearchIntegrityandPeerReview2016

mapping

Web-basedUserManualh^p://www.core-reference.org

LIVETOUR– Disclosure-relatedcontent– Newcontent

SMART AUTHORING

•  PPDandCCIawarenesscomments:“Discussion”excerpt

Hamiltonetal,ResearchIntegrityandPeerReview2016

MONITORING USE

Hamiltonetal,ResearchIntegrityandPeerReview2016

“Discussion”excerpt

ONEYEARON:COREREFERENCEUTILITYSURVEY22MARCH–21APRIL2017

UTILITYSURVEYRESULTS•  Openforonemonth•  Closed21April2017•  FirstpresentaFonofresultstoday

WHEREAREYOURPRIMARYCLIENTLOCATION(S)?(SELECTALLTHATAPPLY)

AnswerChoices ResponsesEurope 69.32%(61)

NorthAmerica 44.32%(39)

Asia-Pacific 19.32%(17)

Restoftheworld 5.68%(5)

TotalRespondents:88;Answered:88;Skipped:0

ROW:restoftheworld;responsesincludedLaFnAmerica,AustraliaandIsrael

WHATTYPEOFORGANIZATIONDOYOUWORKFOR?

AnswerChoices ResponsesLargePharma 18.18%(16)

SmallPharma/Biotech 19.32%(17)

Contractresearchorganiza6on(CRO)

42.05%(37)

Personal/Freelance 17.05%(15)

Government/Regulatory 0.00%(0)

Academia 3.41%(3)

TotalRespondents:88;Answered:88;Skipped:0

WHATISYOURROLE?(SELECTALLTHATAPPLY)

AnswerChoices ResponsesMedicalWriter-Regulatory

89.77%(79)

MedicalWriter-Publica6on

36.36%(32)

MedicalWriter-Medical

29.55%(26)

RegulatoryAffairs 5.68%(5)

Responsibleforpos6ngresults

9.09%(8)

Clinicaltrialsdata–publicdisclosureandtransparency

9.09%(8)

TotalRespondents:88;Answered:88;Skipped:0

HOWHAVEYOUUSEDCOREREFERENCETODATE?(SELECTALLTHATAPPLY)

AnswerChoices ResponsesDownloadedonly 25.00%(22)

Read/reviewedonly 51.14%(45)

UsedtoauthorCSR(s) 28.41%(25)

IncorporatedintoSOPs/policies/templates

34.09%(30)

Asanunofficialreferencetool

37.50%(33)

TotalRespondents:88;Answered:88;Skipped:0

WHATVALUEDOYOUASSOCIATEWITHCOREREFERENCE?DOYOUFINDIT:

AnswerChoices ResponsesVeryvaluable 54.55%(48)

Somewhatvaluable 36.36%(32)

Notvaluable 9.09%(8)

TotalRespondents:88;Answered:88;Skipped:0

HAVEYOUSIGNEDUPTOTHECOREREFERENCEMAILINGLISTONWWW.CORE-REFERENCE.ORG?

AnswerChoices ResponsesYes 52.27%(46)

No 47.73%(42)

TotalRespondents:88;Answered:88;Skipped:0

NowthatyouhavegainedsomefamiliaritywithCOREReference,howusefularesourcedoyouconsideritinpreparingdisclosure-readyCSRs?

A. B. C. D.

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30A.  ExtremelyusefulB.  SomewhatusefulC.  NotatallusefulD.  Notsure

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THANKYOU