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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Yonsei University College of Medicine
2020
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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 |