standards > model/format > DOI:10.25504/FAIRsharing.yr61md


ready CDISC Define eXtensible Markup Language

Abbreviation: CDISC Define-XML


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Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.



How to cite this record FAIRsharing.org: CDISC Define-XML; CDISC Define eXtensible Markup Language; DOI: https://doi.org/10.25504/FAIRsharing.yr61md; Last edited: Nov. 27, 2018, 12:05 p.m.; Last accessed: Dec 15 2018 1:58 p.m.


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Record updated: Nov. 21, 2018, 7:35 p.m. by awhite.

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