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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

In the News: Standardized Submissions — Are You Prepared?

Posted by Fiona Hartley on Jun 30, 2016 12:03:10 PM

Formedix recently attended the DIA 52nd Annual Meeting in Philadelphia, PA, featuring in The Clinical Oncologist Daily show magazine for the initiatives we have put in place to help organizations prepare for the impending FDA regulatory deadline. Read the full interview below with Solutions Consultant Lesley Gordon below.

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Topics: CDISC, Conferences & Events, FDA, Regulatory, Training

Instant gratification is everywhere. Are clinical trials ready?

Posted by Fiona Hartley on Aug 7, 2015 12:27:04 PM

There’s much to marvel at - and just as much to dislike - in our culture of instant gratification.

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Topics: CDISC, End-to-End Clinical Trials, Services, Training