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Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?
BACKGROUND: The increasing number of clinical trials and their complexity make it challenging to detect and identify clinical quality issues timely. Despite extensive sponsor audit programs and monitoring activities, issues related to data integrity, safety, sponsor oversight and patient consent hav...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer International Publishing
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458946/ https://www.ncbi.nlm.nih.gov/pubmed/32865805 http://dx.doi.org/10.1007/s43441-020-00147-x |