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The Formedix Clinic > Define-XML

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

26 April 2018
by Kevin Burges About The Author

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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Using Define-XML for Dataset Design

22 January 2018
by Kevin Burges About The Author

This latest post in our "Introduction to CDISC" series is all about Define-XML. It's known by many due to it being required in regulatory submissions, but why does it exist and what benefits can it bring you?

In the past sponsors submitting to FDA were required to submit a PDF describing their submission datasets.  As we all know PDF is great for viewing on screen or printing, but the information inside it can't be interpreted by a computer in any meaningful way. Enter CDISC's Define-XML model...

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An Introduction to CDISC Standards

8 January 2018
by Kevin Burges About The Author

Let’s start at the start - what is CDISC? The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization.

Formedix have been strong advocates for the use of CDISC data standards in clinical and non-clinical research for half my life now, ever since we realised how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around use of CDISC standards, and are now industry leaders in CDISC software, professional services and training.

Over the next few weeks we’ll be publishing a series of blog posts giving an overview of the various CDISC models. Our aim is to help you understand how you can make the most of these industry standards. If we all work together using the same standards we can optimize our clinical trials by increasing data quality and reducing design and execution time. Ultimately that means getting more products to the market with less cost.

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Standardized data - The industry is struggling

2 October 2017
by Kevin Burges About The Author

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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The Twelve Days of Formedix

14 December 2016
by Fiona Hartley About The Author

The festive period is in full swing, and in the Formedix office, we’re no exception. While we sample festive chocolates, raise a glass over Christmas lunch, or add the star to the top of the office tree, we look back over the year and give a nod to all the great things we’re excited to offer, here at Formedix.

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CDISC Define-XML 1.0 Comes to the End of its Life

28 July 2016
by Fiona Hartley About The Author

REGULATORY DEADLINE UPDATE: The FDA Data Standards Catalog has recently been updated to state that Define-XML v1.0 cannot be used in studies starting after March 15, 2018 . The Catalog previously stated March 2017, however the update now aligns with the date communicated on the Federal Register Notice.

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Homegrown Define-XML vs. Automated Define-XML

23 September 2015
by Ed Chappell About The Author

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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SDTM and Define-XML: Two Separate Standards

17 September 2015
by Fiona Hartley About The Author

“You’d be surprised how many people in the industry don’t realize that the Study Data Tabulation Model (SDTM) and Define-XML are two separate standards,” said my colleague Ed in a meeting last week.

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

23 July 2015
by Fiona Hartley About The Author

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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Formedix #DIA2015 Interviews: CDISC Standards Deadline Raises Bar for Japanese Firms

1 July 2015
by Fiona Hartley About The Author

Ahead of this year's DIA 2015 Annual Meeting, Formedix commissioned a series of three interviews with some of our CDISC standards experts. In the second, our man in Japan Masahiro Hayashi talks about the country's looming CDISC deadline, and what it means for its pharmaceutical companies.

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