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

dc.creator	Gerlinger, C.	en
dc.creator	Edler, L.	en
dc.creator	Friede, T.	en
dc.creator	Kieser, M.	en
dc.creator	Nakas, C. T.	en
dc.creator	Schumacher, M.	en
dc.creator	Seldrup, J.	en
dc.creator	Victor, N.	en
dc.date.accessioned	2015-11-23T10:27:45Z
dc.date.available	2015-11-23T10:27:45Z
dc.date.issued	2012
dc.identifier	10.1002/sim.4345
dc.identifier.issn	0277-6715
dc.identifier.uri	http://hdl.handle.net/11615/27791
dc.description.abstract	International 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.	en
dc.source	Statistics in Medicine	en
dc.source.uri	<Go to ISI>://WOS:000304088900025
dc.subject	qualified statistician	en
dc.subject	regulatory affairs	en
dc.subject	ICH	en
dc.subject	guideline	en
dc.subject	Mathematical & Computational Biology	en
dc.subject	Public, Environmental &	en
dc.subject	Occupational Health	en
dc.subject	Medical Informatics	en
dc.subject	Medicine, Research &	en
dc.subject	Experimental	en
dc.subject	Statistics & Probability	en
dc.title	Considerations on what constitutes a 'qualified statistician' in regulatory guidelines	en
dc.type	journalArticle	en

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