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How to Describe Multiple Origins for a Value in Define-XML 2

Posted by Kevin Burges on Apr 26, 2018 12:29:03 PM

There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how to handle data that can come from multiple sources, such as a CRF or eDT. In the simple case you just create a Value List, and specify the Origin on each Value instead of on the Variable.

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Topics: CDISC, CRFs, Datasets, Define-XML, Training, Dataset-XML

Standardized data - The industry is struggling

Posted by Kevin Burges on Oct 2, 2017 1:30:36 PM

With FDA now regulating for all new studies to use CDISC standards when submitting data, it's vital that our processes are up to date with the latest standards and fit for purpose.

An FDA presentation at the recent PhUSE Computational Science Symposium tried to shed some light on how we're doing as an industry. It analysed all eCTD submissions from January-February 2017 that used standardized data.

You might be surprised how the submissions fared...
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Topics: CDISC, Datasets, Define-XML, FDA, Regulatory, SDTM, SEND, Standards, Submissions, Training

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