Articles with "cdisc standards" as a keyword



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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

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Published in 2022 at "Nagoya Journal of Medical Science"

DOI: 10.18999/nagjms.84.1.120

Abstract: ABSTRACT 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… read more here.

Keywords: standards consortium; data interchange; clinical data; academia ... See more keywords