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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

Using Define-XML for Dataset Design

Posted by Kevin Burges on Jan 22, 2018 4:30:00 PM

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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Topics: CDISC, Define-XML, SDTM, SEND, ADaM

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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How To Handle Skipped Questions in SDTM QS Domains

Posted by Kevin Burges on Nov 13, 2017 4:00:21 PM

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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Topics: FDA, SDTM, ADaM

3 Things You Should Know About the Analysis Data Model (ADaM)

Posted by Fiona Hartley on Sep 4, 2015 3:02:02 PM

One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate figures, listings and tables more easily, and ensures traceability, which means that reviewers are able to review and approve a submission more quickly.

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Topics: CDISC, SDTM, Standards, ADaM