Define XML

To describe any tabular dataset structure Define XML is used as it helps to transmit metadata. In compliance with CDISC fulfilled norms, it provides the metadata for human & animal model datasets using the SDTM or SEND standards & analysis datasets using ADaM.

Define-XML is prescribed by the United States Food and Drug Administration &Pharmaceuticals and Medical Devices Agency. It is used for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms& other specified metadata were used.