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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2021
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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 |