10.25504/FAIRSHARING.YR61MD
FAIRsharing Team
FAIRsharing record for: CDISC Define eXtensible Markup Language
CDISC Define-XML
FAIRsharing
2015
Biomedical Science
Preclinical Studies
This FAIRsharing record describes: 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.
The source of this description is the metadata record on FAIRsharing.org, an educational and informative resource that describes and links databases, standards, and data policies. FAIRsharing also creates collections of these resources and recommendations of databases and standards based on 3rd party data policies.