A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial

Submitting data compliant with the Clinical Data Interchange Standards Consortium (CDISC) standards is mandatory for new drug applications (NDAs). The standards set by CDISC are widely adopted in the pharmaceutical business world. Introduction of CDISC standards in academia can be necessary to reduc...

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Detalles Bibliográficos
Autores principales: Takahara, Shizuko, Saito, Toshiki I., Imai, Yasuhito, Kawakami, Takahiro, Murayama, Toshinori
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nagoya University 2022
Materias:
Original Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8971042/
https://www.ncbi.nlm.nih.gov/pubmed/35392016
http://dx.doi.org/10.18999/nagjms.84.1.120

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