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An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

BACKGROUND: Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based mo...

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Detalles Bibliográficos
Autores principales: Beever, Daniel, Swaby, Lizzie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734501/
https://www.ncbi.nlm.nih.gov/pubmed/31500656
http://dx.doi.org/10.1186/s13063-019-3619-6