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FAIRsharing.yr61md; Last edited: Jan. 8, 2019, 1:38 p.m.; Last accessed: Jan 03 2022 7:14 p.m.

Other names: CDISC Define-XML

Names

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CDISC Define eXtensible Markup Language

metasource: Fairsharing.org
version: FAIRsharing.org: CDISC Define-XML; CDISC Define eXtensible Markup Language; DOI: https://doi.org/10.25504/FAIRsharing.yr61md; Last edited: Jan. 8, 2019, 1:38 p.m.; Last accessed: Jan 03 2022 7:14 p.m.

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.

Description

More detailed information about this field from each metasource.

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.

Webpage:

https://www.cdisc.org/standards/data-exchange/define-xm

Webpage

More detailed information about this field from each metasource.

https://www.cdisc.org/standards/data-exchange/define-xm

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Data is amalgamated and only retrieved periodically.
Some of the resources used by the system:

® FAIRsharing.org
® Bioontology/Bioportal Terms
® Nucleic Acid Research - Database
® re3data.org
® bio.tools
® PubMed - Courtesy of the U.S. National Library of Medicine