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Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit

BACKGROUND: Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these ai...

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Detalles Bibliográficos
Autores principales: Tudur Smith, Catrin, Williamson, Paula, Jones, Ashley, Smyth, Alan, Hewer, Simon Langton, Gamble, Carrol
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4022377/
https://www.ncbi.nlm.nih.gov/pubmed/24739398
http://dx.doi.org/10.1186/1745-6215-15-127