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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nagoya University
2022
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Materias: | |
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 |