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

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Abstract

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.

This paper illustrates how the define.xml can be transformed into relational SAS® data sets by using SAS XML Mapper technology. Once the content of the define.xml is available in SAS data sets it can be presented as a PDF file with the use of SAS ODS (Output Delivery System).

Online Materials

View the pdf for Understanding the define.xml File and Converting It to a Relational Database.

Download the workshop zip file.

Contact Info

User Page: Lex Jansen.