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Define-XML 2.0 Completion Guidelines and Stylesheet Recommendations

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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).

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