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Using ODM and CDASH for CRF Design

Posted by Kevin Burges on Jan 15, 2018 4:30:00 PM

Over the last few years our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SDTM, SEND and ADaM.

This post shines a spotlight on the lesser known Operational Data Model (ODM) standard, which is often overlooked as it's not required by any regulators. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Finally they can be used to drive your data collection system. In short, they put you in control.

With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to re-use and increased consistency between studies. 

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An Introduction to CDISC Standards

Posted by Kevin Burges on Jan 8, 2018 4:30:00 PM

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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Controlled Terminology and CDASH

Posted by Fiona Hartley on Oct 15, 2015 4:33:07 PM

Because the focus of CDASH (Clinical Data Acquisition Standards Harmonization) is on data collection, not data reporting, it works a little differently from the rest of the CDISC content standards. Since there is a disconnect between collection and reporting, the point of CDASH is to bridge that gap by showing how data should be collected, minimizing the disparity with reporting.

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Topics: CDASH, CDISC, Controlled Terminology, CRFs, SDTM

Annotation Frustration: The pitfalls of non-CDISC CRFs

Posted by Fiona Hartley on Oct 1, 2014 3:15:34 PM

Any data managers who have attempted to annotate a non-CDASH CRF with SDTM variables will know that it is somewhat of an ordeal.

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What can be achieved with CDISC ODM? Standardized libraries of content are just the beginning...

Posted by Ed Chappell on Mar 5, 2014 3:57:16 PM

Recently, there have been comments about the Lilly ODM library no longer being available on the CodePlex website.

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Topics: CDASH, CDISC, CRFs, End-to-End Clinical Trials, ODM

5 Reasons to be Thankful this Thanksgiving

Posted by Darren Bill on Nov 27, 2013 10:45:47 AM

Happy Thanksgiving!

It is that time of year when, once again, we gather with friends and family, eat far too much and give thanks for everything we are so grateful for. At Formedix, we have a lot to be thankful for this year so we have made a short infographic to share with you some of the things we are so happy to have.

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Topics: CDASH, CDISC, Content Reuse, Define-XML, EDC

The word on the street is CDISC...

Posted by Fiona Hartley on Nov 19, 2013 10:50:17 AM

There has been a major buzz around CDISC these past few weeks and we have been shouting about it as much as anyone!

As a true CDISC expert and standards advocate since 2000, CEO, Mark Wheeldon was invited to speak at the New Jersey CDISC User Group, held in September at Merck in Summit. Mark was discussing all things CDASH, how the standard works with multi-EDC vendors and how it can be implemented throughout the end-to-end clinical trial process.

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Topics: CDASH, CDISC, End-to-End Clinical Trials, SDTM, Submissions, Study Build, Study Design