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Homegrown Define-XML vs. Automated Define-XML

Posted by Ed Chappell on Sep 23, 2015 3:12:55 PM

During the SDTM dataset extraction process, some SAS programmers create the SDTM or ADaM Define-XML directly from the dataset metadata used in the SAS file. This has the perceived advantage of automating the Define-XML creation, but it has a fundamental weakness.

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Topics: CDISC, Datasets, Define-XML, SAS

Who Converts Wins: How to create Define-XML from SAS XPT datasets

Posted by Fiona Hartley on Jul 23, 2015 2:48:00 PM

When submitting clinical data to a regulator in electronic format, you’ll need to include metadata - data about the data - in the form of a Define-XML. This CDISC-format file helps the reviewer who’ll eventually approve or reject your application by describing the format and content of the data submitted.

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Topics: CDISC, Define-XML, SAS, Services, Submissions