Publication:
Considerations on what constitutes a 'qualified statistician' in regulatory guidelines

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dc.bibliographiccitation.firstpage1303
dc.bibliographiccitation.issue11-12
dc.bibliographiccitation.journalStatistics in Medicine
dc.bibliographiccitation.lastpage1305
dc.bibliographiccitation.volume31
dc.contributor.authorGerlinger, Christoph
dc.contributor.authorEdler, Lutz
dc.contributor.authorFriede, Tim
dc.contributor.authorKieser, Meinhard
dc.contributor.authorNakas, Christos T.
dc.contributor.authorSchumacher, Martin
dc.contributor.authorSeldrup, Jorgen
dc.contributor.authorVictor, Norbert
dc.date.accessioned2018-11-07T09:10:19Z
dc.date.available2018-11-07T09:10:19Z
dc.date.issued2012
dc.description.abstractInternational regulatory guidelines require that a qualified statistician takes responsibility for the statistical aspects of a clinical trial used for drug licensing. No consensus on what constitutes a qualified statistician appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept. Copyright (C) 2011 John Wiley & Sons, Ltd.
dc.identifier.doi10.1002/sim.4345
dc.identifier.isi000304088900025
dc.identifier.pmid21948351
dc.identifier.urihttps://resolver.sub.uni-goettingen.de/purl?gro-2/26459
dc.item.fulltextNo Fulltext
dc.notes.statuszu prüfen
dc.notes.submitterNajko
dc.publisherWiley-blackwell
dc.publisher.placeHoboken
dc.relation.conference31st Annual Conference of the International-Society-for-Clinical-Biostatistics
dc.relation.eventlocationMontpellier, FRANCE
dc.relation.issn1097-0258
dc.relation.issn0277-6715
dc.titleConsiderations on what constitutes a 'qualified statistician' in regulatory guidelines
dc.typeconference_paper
dc.type.internalPublicationyes
dc.type.peerReviewedyes
dc.type.statuspublished
dspace.entity.typePublication

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