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Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review

BACKGROUND/AIMS: It is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have recently encouraged more risk-based monitoring. Risk assessment should take place before a trial begins to define the overarching monitori...

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Detalles Bibliográficos
Autores principales: Cragg, William J, Hurley, Caroline, Yorke-Edwards, Victoria, Stenning, Sally P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010889/
https://www.ncbi.nlm.nih.gov/pubmed/33611927
http://dx.doi.org/10.1177/1740774520976561