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  1. Formedix
19 October 2020

How the Formedix Visual Define.xml Editor Gives You Faster Define

Define.xml is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.

It’s based on the CDISC ODM standard and is a key requirement for electronic submissions to the FDA and PDMA.

Creating a define.xml requires a lot of programming expertise. And it takes a lot of time. That’s why it’s so important to make the process as quick and easy as possible.

How do I get faster define.xml in Formedix?

There’s no manual work. And there’s no programming involved. So, that means no XML or SAS expertise is needed.

All you have to do is click a button once to get your define.xml. Or another button click gives you define.xml as pdf or define.html.

But just before that button is ready to be clicked, there’s a bit of setup to do beforehand.

  1. First of all, get your metadata into Formedix. You can import and convert SAS XPT files and old legacy files. Or you can import spreadsheets for conversion.
  2. Build your study. You can import existing standards to do this, making it a quick and easy process. Or, import content directly into Formedix from the Medidata Rave EDC or the Oracle InForm EDC.
  3. Define your datasets using the built-in SDTM and ADaM templates. Check to see if all the validation rules are met. And fix anything that’s not quite right.
  4. Now, all you need to do is click a button and you have your submission ready define.xml!

And, as an added bonus, you can reuse your datasets and mappings. They’ve already been tried and tested, so next time, setup is even quicker and easier!

What about validation?

Our validation tool lets you check your datasets against rules for standards. Any problems are highlighted and you can see exactly where to fix them. This means you can validate your study throughout the process. Then, when it is time for submission, everything is correct!

It is quick and easy to see your clinical metadata. You can preview a full definition of your define with links to annotated CRFs and submission datasets. And visualise your Define in PDF format with links to the annotated CRF.

What are the benefits of using the Formedix visual define XML editor?

No programming means no SAS expertise is required. Less time spent on programming, means you save money. And there is a lot less effort required!

The Define-XML standard is built-in. So, you do not have to worry about non-compliance. And our platform complies with FDA and NCI standards too.

Our validation tool lets you check your datasets are correct. If there are any issues, you can easily see where to find and fix them.

It is just a one-button click to generate define.xml, define.pdf, and define.html. And that is about as stress-free as you can get!

So all this boils down to you being able to submit your studies much faster!

Other benefits

The CDISC Define-XML standard is built into our study automation platform. So there is no need to worry about not sticking to the rules. You can use the validation tools to see if there is anything wrong with your datasets before generating your define.xml.

If you design your forms in the Formedix platform, you can predict your define.xml. And, it is really accurate. This makes designing your datasets much easier. And much quicker!

SDTM, ADaM, and SEND templates to help you build your datasets. It is easy to add domains and variables. And there are various versions to choose from.

Formedix has been in the business for 20 years. In that time, we have really listened to our customers about what they want. And we have become experts in CDISC standards.

As members of the CDISC development team, we have been involved in developing Define-XML 2.0. And, do not forget the upcoming Define-XML 2.1.

Being so involved with CDISC means the Formedix platform is always up to date. There is no need to worry about not meeting Define standards in the future. But that doe not mean we forget about previous versions. You can continue to create your define.xml in whatever version you need.

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