Define-XML 2.0 Completion Guidelines and Stylesheet Recommendations

Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.

Define-XML is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page