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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2019
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| 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 |