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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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Detalhes bibliográficos
Main Authors: Tudur Smith, Catrin, Williamson, Paula, Jones, Ashley, Smyth, Alan, Hewer, Simon Langton, Gamble, Carrol
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4022377/
https://ncbi.nlm.nih.gov/pubmed/24739398
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1745-6215-15-127
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