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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
[quesFontoaudiencefollowingpresentaFon]
THANKYOU
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