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Using NCI Controlled Terminology for Standardizing Data

Posted by Kevin Burges on Feb 5, 2018 4:30:00 PM

Use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and ADaM standardize the structures to use when collecting and submitting data, but what about the data values themselves?

This post gives an overview of CDISC's standardized controlled terminology and how it should be used to collect and submit data in a way that speeds trials and enables cross study analysis.

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Topics: CDISC, Controlled Terminology, Regulatory, SDTM, SEND, Submissions, ADaM

Using SDTM, ADaM and SEND for Regulatory Submissions

Posted by Kevin Burges on Jan 29, 2018 4:30:00 PM

It's a safe bet that most people's first introduction to CDISC is through the SDTM. This is a content standard that ensures clinical data is submitted in a consistent manner, helping reduce review time and facilitating cross study analysis. Another content standard, ADaM, aims to perform a similar function for analysis datasets. Likewise SEND defines standardized domains for non-clinical data. 

Adoption of these standards is driven by regulators such as FDA and PMDA, who mandate that data must be submitted in these formats.

This post gives a very brief overview of each model, how they fit in with the wider clinical trial process, and how you can get maximum benefit from them.

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Topics: CDISC, Regulatory, SDTM, SEND, Submissions, ADaM, Analysis Results Metadata

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

When Should I Use CDISC SDTM v1.5?

Posted by Ed Chappell on Sep 27, 2016 12:36:13 PM

Earlier this month, I participated on the Q&A panel for our CDISC SDTM-IG webinar. During the webinar we received an interesting and very timely question around the use of CDISC SDTM v1.5. I was asked “CDISC have released SDTM 1.5, should we use this instead of SDTM 1.4?”  So here is my quick guide on the appropriate use of the standard…


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Topics: CDISC, FDA, Regulatory, SDTM, SEND, Standards, Submissions

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

15 Changes in Clinical Trials Since 2000: Part 2

Posted by Fiona Hartley on Mar 16, 2015 4:28:38 PM

We’re celebrating the 15th Anniversary of Formedix this year. It got us thinking about how the clinical trials world has changed since we've been around: sometimes it feels like little has changed in 15 years, but often it feels like the pace of change is unsustainable. This is the second in our three-part series - part one is here, and part three is here. Read on for part two of our top 15 things that have changed in clinical trials since 2000.

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Topics: End-to-End Clinical Trials, FDA, #Formedix15, Pharma, Submissions

Tracking the evolution of CDISC SDTM

Posted by Ed Chappell on Feb 21, 2014 1:48:59 PM

While sitting in Reykjavik airport recently, I found myself pondering the growth of the SDTM general observation classes over the years. At Formedix, we create machine readable templates for each version of the SDTM standard, which, over time, has provided a series of snapshots of the SDTM standard. Being unable to understand Icelandic television, I decided to extract some basic statistics from the SDTM templates and analyze exactly how they had changed from version to version. The results are rather surprising...

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Topics: CDISC, End-to-End Clinical Trials, SDTM, Social Media, Standards, Submissions, Study Build, Study Design

Break free from XPT files with CDISC Study Dataset-XML

Posted by Kevin Burges on Dec 6, 2013 11:06:34 AM

If you work with clinical study submissions you'll be well aware of the long-standing FDA requirement to use SAS Transport (XPT) files to transport your datasets. You'll also likely know about the numerous issues and complexities this format imposes. Let me name just three…

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Topics: CDISC, Define-XML, End-to-End Clinical Trials, Submissions

'CRO industry revenue expected to double'...will you be part of it?

Posted by Fiona Hartley on Nov 21, 2013 10:44:50 AM

We all know that the end-to-end clinical trial process is becoming more complex and more heavily regulated, week on week, by authorities such as the FDA. We regularly learn of customers and industry professionals who are outsourcing to Contract Research Organizations (CROs) to undertake their studies, and it is becoming increasingly more popular - around 40% of drug development is currently outsourced.

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Topics: CROs, End-to-End Clinical Trials, Outsourcing, Submissions, Study Build, Study Design

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