Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated...

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Detalles Bibliográficos
Publicado en:Trials
Main Authors: Hurley, Caroline, Sinnott, Carol, Clarke, Mike, Kearney, Patricia, Racine, Emmy, Eustace, Joseph, Shiely, Frances
Formato: Artigo
Idioma:Inglês
Publicado: BioMed Central 2017
Assuntos:
Research
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC5594426/
https://ncbi.nlm.nih.gov/pubmed/28893317
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13063-017-2148-4
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