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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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Autori principali: Tudur Smith, Catrin, Williamson, Paula, Jones, Ashley, Smyth, Alan, Hewer, Simon Langton, Gamble, Carrol
Natura: Artigo
Lingua:Inglês
Pubblicazione: BioMed Central 2014
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Accesso online: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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