The Formedix Clinic

Drop in and catch up on the latest news and standards knowledge. No appointment necessary.

Formedix On Platform Updates: February 2018

5 March 2018
by Fiona Hartley About The Author

In late February 2018, we added new functionality our clinical trial automation platform, Formedix On, to further enhance our users' experience. Improved search functionality for trial assets, a new read-only subscription to view your metadata repository, and improved usability for editing objects such as questions on case report forms (CRFs), are among the highlights of the release.

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Using NCI Controlled Terminology for Standardizing Data

5 February 2018
by Kevin Burges About The Author

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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Using SDTM, ADaM and SEND for Regulatory Submissions

29 January 2018
by Kevin Burges About The Author

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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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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Using ODM and CDASH for CRF Design

15 January 2018
by Kevin Burges About The Author

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

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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How To Handle Skipped Questions in SDTM QS Domains

13 November 2017
by Kevin Burges About The Author

Standardized questionnaires often contain questions that should only be answered depending on the response to a previous question.  Until now, such data has been submitted inconsistently to FDA, as CDISC SDTM does not provide any guidance on how to indicate that the questions have been "logically skipped". Thankfully FDA have just updated their Study Data Technical Conformance Guide to standardize how information about these logically skipped questions should be submitted. It's fairly simple...

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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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When Should I Use CDISC SDTM v1.5?

27 September 2016
by Ed Chappell About The Author

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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