Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment

BACKGROUND: Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, th...

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Detalles Bibliográficos
Autores principales: Kondo, Hidenobu, Kamiyoshihara, Tomoaki, Fujisawa, Kenji, Nojima, Toshiaki, Tanigawa, Ryohei, Fujiwara, Hisataka, Suganami, Hideki, Hayashi, Yukikazu, Yamaguchi, Takuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238712/
https://www.ncbi.nlm.nih.gov/pubmed/33876398
http://dx.doi.org/10.1007/s43441-021-00286-9

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