DEFINE XML

To describe any tabular dataset structure Define-XML is used, as it helps to transmit metadata. In compliance with 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 prescribed by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). It is used for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.