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Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines

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 C...

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Bibliographic Details
Main Authors: Gerlinger, Christoph (Author) , Edler, Lutz (Author) , Kieser, Meinhard (Author) , Victor, Norbert (Author)
Format: Article (Journal)
Language:English
Published: 2012
In: Statistics in medicine
Year: 2012, Volume: 31, Issue: 11/12, Pages: 1303-1305
ISSN:1097-0258
DOI:10.1002/sim.4345
Online Access:Verlag, Volltext: http://dx.doi.org/10.1002/sim.4345
Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.4345
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Author Notes:Christoph Gerlinger, Lutz Edler, Tim Friede, Meinhard Kieser, Christos T. Nakas, Martin Schumacher, Jørgen Seldrup and Norbert Victor

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