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Risk-based monitoring: Review of the current perceptions and toward effective implementation
The United States Food and Drug Administration issued a guidance to industry in August 2013 on risk-based approach to monitoring. This prompted industry (sponsors and contract research organizations) to brainstorm, conceptualize, and implement risk-based monitoring (RBM) in their clinical studies an...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Wolters Kluwer - Medknow
2019
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463506/ https://www.ncbi.nlm.nih.gov/pubmed/31008070 http://dx.doi.org/10.4103/picr.PICR_18_18 |