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Understanding the Define.xml File and Converting It to a Relational Database

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Executive Summary

When submitting clinical study data in electronic format to the FDA, not only information from trials has to be submitted, but also information to help understand the data. Part of this information is a data definition file, which is the metadata describing the format and content of the submitted data sets. When submitting data in the CDISC SDTM format it is required to submit the data definition file in the Case Report Tabulation Data Definition Specification (define.xml) format as prepared by the CDISC define.xml team.

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