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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Detalhes bibliográficos
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2011
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3074516/
https://ncbi.nlm.nih.gov/pubmed/21426576
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1745-6215-12-85
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