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 |