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. It takes a lot of time. That’s why it’s so important to make the process as quick and easy as possible.
And, if you’re interested, Formedix has written blogs on How to Describe Multiple Origins for a Value in Define-XML 2 and Using Define-XML for Dataset Design.
Can the ryze visual Define-XML editor make it quick and easy?
Yes! 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 to get your Define-XML. Or another button click gives your Define-XML as pdf or Define-HTML.
Is it really that easy?
Yes and no… It really is just a click of a button to get your Define files. But there’s a bit of setup to do beforehand:
First of all, get your metadata into ryze. You can import and convert SAS XPT files and old legacy files. Or you can import spreadsheets for conversion.
Next, build your study. You can import existing standards to do this making it a quick and easy process. Or, import content directly into ryze from the Medidata Rave EDC or the Oracle InForm EDC (or choose from other leading EDCs).
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.
All you need to do is click a button and you have your submission ready Define-XML!
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 else can help?
The CDISC Define-XML standard is built into the ryze study automation platform. So there’s no need to worry about not sticking to the rules. You can use the validation tools to see if there’s anything wrong with your datasets before generating your Define-XML.
If you design your forms in ryze, you can predict your Define-XML. And, it’s really accurate. This makes designing your datasets much easier. And much quicker!
SDTM, ADaM and SEND templates to help you build your datasets. It’s easy to add domains and variables. And there are various versions to choose from.
What about validation?
ryze validation tools let 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’s time for submission, everything’s correct!
It’s 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 visualize your Define in PDF format with links to the annotated CRF.
What are the benefits of using the Formedix ryze Visual Define-XML Editor?
No programming means no SAS expertise required. Less time spent on programming means you save money. And that’s a lot less effort required!
The Define-XML standard is built-in. So you don’t have to worry about non-compliance. And ryze complies with FDA and NCI standards too.
The validation tool lets you check that your datasets are correct. If there are any issues, you can easily see where to find and fix them.
It’s just one button click to generate Define-XML, Define-PDF, and Define-HTML. And that’s about as stress-free as you can get!
So all this boils down to you being able to submit your studies much faster!
Sounds good? Get in touch with Formedix!
Request a no-strings software demo here. Let the Formedix team know what you need and they’ll show you how they can help.
This post was originally published on Source Link