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Standard requirements for GCP-compliant data management in multinational clinical trials

BACKGROUND: A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer...

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Detalles Bibliográficos
Autores principales: Ohmann, Christian, Kuchinke, Wolfgang, Canham, Steve, Lauritsen, Jens, Salas, Nader, Schade-Brittinger, Carmen, Wittenberg, Michael, McPherson, Gladys, McCourt, John, Gueyffier, Francois, Lorimer, Andrea, Torres, Ferràn
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074516/
https://www.ncbi.nlm.nih.gov/pubmed/21426576
http://dx.doi.org/10.1186/1745-6215-12-85

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