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The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles

Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on si...

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Detalles Bibliográficos
Autores principales: Ansmann, Eva B., Hecht, Arthur, Henn, Doris K., Leptien, Sabine, Stelzer, Hans Günther
Formato: Online Artículo Texto
Lenguaje:English
Publicado: German Medical Science GMS Publishing House 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3563312/
https://www.ncbi.nlm.nih.gov/pubmed/23382708
http://dx.doi.org/10.3205/000172