Define-XML

Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC Foundational 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 FDA and PMDA for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.