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Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials

PURPOSE: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical practice. The aim of this research was to propose for ris...

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Detalles Bibliográficos
Autores principales: Kim, EunHee, Lim, Chiyeon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Yonsei University College of Medicine 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214110/
https://www.ncbi.nlm.nih.gov/pubmed/32390366
http://dx.doi.org/10.3349/ymj.2020.61.5.423

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