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PUSH A BUTTON… OUT POPS DEFINE.XML

The hard work’s already done. Now you’re just 1 click away from define.xml

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CREATE DEFINE XML IN 1 CLICK

Once you’ve finished your study, it’s all about FDA submission. And that means having your study metadata in STDM define.xml format. Unless you’ve got the right programming skills, this can be a really daunting and time consuming process.

The quick way? Create define.xml in Formedix. Once your metadata is in our library, you’ve built your study and defined your datasets, you can create define.xml file with 1 click in our visual define.xml editor. No need to understand code or XML. Or if it’s a spreadsheet, import it into Formedix to convert. You can even convert a SAS XPT file or old legacy datasets. See how our visual define XML editor gives you faster define.

Want to create define.pdf file for your FDA submission? Just click a different button. Not only do you save time at the end of your study, you have the chance to get your study submitted much sooner too.

What can I do with Formedix?

HOW WE HELP YOU COMPLY WITH THE DEFINE-XML STANDARD

What is define.xml?
Submission of clinical study data to regulatory agencies, such as the FDA, requires clinical data from trials. Furthermore, it also requires the information to describe the data being submitted. A major component of this additional information is the data definition file – or the define.xml. The define.xml is the metadata describing the content and formatting of the all the submission datasets. Define.xml is prepared by the CDISC define.xml team. Submission of data in the CDISC format requires an SDTM define.xml file to describe the Case Report Tabulation Data. Here you can see an example of a define.pdf.

The Define-XML standard
The Define-XML standard is based on the CDISC Operational Data Model (ODM) XML schema. The CDISC Operational Data Model is intended to be vendor neutral and platform independent. This allows the interchange of clinical study data in a non-bias format. Therefore it is required for submission of all studies to the FDA and other agencies. Being a required study deliverable, it’s easy to see why being able to quickly and correctly create a define.xml file is so important. And that’s where our visual xml editor can help!

We know Define-XML – so you don’t have to
Formedix has many years of experience and a wealth of knowledge of CDISC standards – including visual define XML automation. We are members of the Define-XML Development team. As such, Formedix had a key role in the development of the Define-XML 2.0 standard (and also the upcoming Define-XML 2.1 standard). We draw on this knowledge to implement key requirements of the Define-XML standard into our visual define.xml editor tool.

Automatically comply with Define-XML
Being able to embed the Define-XML standard into our platform helps you automatically abide by the Define-XML standard when designing your metadata. You have an immediate advantage. This also minimizes future effort needed to create define compliant metadata – you know that compliance will be incorporated into your dataset design by default!

You see quickly see the differences between Define-XML 1.0 and Define-XML 2.0.

What about updates?
Formedix is at the forefront of updates to standards. We quickly integrate any updates across all aspects of our platform. And we continue to support previous versions of standards so that you’ve got the flexibility to create define.xml in whatever version you need.

WHAT'S IN IT FOR ME?

CREATE DEFINE IN 1 CLICK - NO PROGRAMMING NEEDED

Create SDTM define.xml files at the click of a button in Formedix. Our platform has a visual define XML automation tool built in so there’s no manual work involved. And you don’t need to be a SAS expert. Instantly convert Excel or SAS XPT files to define.xml, define.pdf, or define.html with our visual XML editor.

SAVE TIME & SUBMIT STUDIES FASTER

Because you create define.xml files much quicker, you can be ready to submit your study to the FDA much sooner.

EFFORTLESSLY COMPLY WITH STANDARDS

Because we’ve built the Define-XML standard into Formedix, you automatically comply with the rules. You’re using a platform that’s built on the latest FDA and NCI standards. Plus, you’re covered for older standards – we still support those too.

EASY VALIDATION

Our validation tools help you check your datasets, and spot any deviations from Define-XML standards. So when you’re ready to create your define file for submission, you can be confident that it complies.

HOW TO CREATE DEFINE & OTHER STANDARDS

How to create define-xml metadata with Formedix
You can easily create dataset metadata specifications in Formedix. To make things easier, we’ve embedded the Define-XML standards into the dataset design process. This means that anytime you create datasets in Formedix, they will conform to the Define-XML standard. The platform guides you on what to create, so that your metadata is Define-XML compliant.

SDTM, ADaM, SEND & ARM
We’ve incorporated SDTM, ADaM and SEND into an easy to use define structure. All aspects of the define.xml are captured, in order to ensure a valid submission. This covers everything you need for the final submission, plus any deviation from CDISC standards. For example, for ADaM you can create Analysis Results Metadata (ARM) in Formedix. ARM metadata is only applicable for ADaM, and we’ve given you the tools to describe ARM for a study. This is just one example of how we help you work with new standards very quickly.

Validation of Define-XML
You can check SDTM datasets or ADaM datasets and note any non-compliance with Define-XML standards in Formedix. This constant ability to validate datasets makes it easy to create valid, consistent Define-XML metadata in Formedix. So when it comes to creating your define.xml file, you can rest assured that it will be acceptable for submission. All that’s left is to extract your final define.xml file at the click of a button. Same thing if you need define.pdf files. Just 1 click and you’re done!

Formedix Professional Services – ask us to convert Excel and SAS to Define-XML
The Formedix Professional Services department can convert various data formats into define.xml for you. We can extract the relevant information from a number of formats – such as Excel and SAS XPT – in order to create a define.xml file for use in Formedix. We can extract the necessary information and infer any other information required to make the define.xml valid. Here you can find out more about our Services and how we can help.

CREATE SDTM DEFINE.XML IN 1 CLICK WITH OUR VISUAL XML EDITOR

Instantly make SDTM.define and ADaM-based define.xml from your Formedix datasets.

Preview Define-XML
Formedix offers many ways to visualize and publish the Define-XML metadata created in our platform. By default, you can preview the define.xml file using the published CDISC stylesheet. This gives a quick and easy way to see your metadata. It includes full definition of the define; page links to annotated CRFs; and hyperlinks to the submission datasets. In addition, we stay up-to-date with any changes to the stylesheet as released by CDISC.

Another way to see your define.xml metadata is to use the Formedix tools to visualize it in PDF format. This also contains hyperlinks for any page references to the annotated CRF. That way you have a nice user friendly way to see your define and share it with colleagues.

Define-XML prediction
Formedix also lets you predict the define.xml that will be created based on your form design. When you create a study in Formedix and design forms for an EDC system, the platform accurately predicts the define.xml for the datasets that would be created, based on the form design for that given EDC system.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

CONVERT MY DATA TO DEFINE.XML

Get in touch to find out how to create define.xml faster with our visual define.xml editor.

WHY WE'RE DIFFERENT

No other platform automatically builds your study in just about any EDC system – 7 to date. Use your favourite, or even different EDCs for different studies. Not only does it give you flexibility, but you save loads of time with you clinical study build. Plus you only need to learn one platform and you get to build studies in different EDCs. 

Unlike others, you can truly reuse content and save time. No need to retype spreadsheet content for example. Simply reuse content from 1 study to another, and even across multiple EDC systems.

Some companies don’t improve or expand their platform. We do, constantly. We’re always working on new stuff, and it’s based on your feedback. Just ask to see our product road map

It takes a fraction of the time to set up your study in Formedix compared with other systems. Your typical 21 week study takes on average just 14 weeks. And the sooner you start your trials, the sooner you potentially launch products (= faster ROI).

Only we integrate 100% with Rave and InForm. So as well as seeing what something will look like before you build it, you can do edit checks and preview eCRFs too.

Ours is the only fully integrated clinical metadata repository. There’s other clinical metadata repository’s, but with ours your content is interconnected, so the parts all ‘talk to each other’. Formedix is also the only commercially available off-the-shelf clinical metadata repository. So you can start straight away, we don’t need to custom build it from scratch. And that means a quick and pain free implementation for you!

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

Frequently Asked Questions

How will Formedix help me comply with the Define XML standard?

The Define XML standard is built into our platform. That means you’ll automatically comply when designing your metadata. So less effort is needed in the future to create define compliant metadata – compliance is built into your dataset design by default.

What is SDTM Define.xml?

SDTM define.xml is a document that describes the structure and content of data collected during a clinical trial and is required for a regulatory submission. The SDTM Define standard supports the submission of clinical trial data in CDISC SDTM for regulatory submissions.

What are the benefits of the visual define.xml editor?

The FDA requires all submissions to use Define XML to describe datasets. In Formedix, you can quickly define your SDTM, SEND and ADaM datasets upfront using the visual define.xml editor. And you’ll be confident knowing your submission will be compliant.

Can you generate SDTM Define XML metadata directly from XPT datasets in Formedix?

Yes, our visual define.XML editor lets you do this. And it’s easy to understand the content of datasets and use them appropriately.

What are "where clauses" used for in Define XML 2?

They are used to specify when a specific Value definition applies.

How do you handle data from multiple sources in Define XML 2?

By using “where clauses”. You need to create 2 values with the same name – however they must have different OIDs. Find out more about Describing Multiple Origins for a Value in Define-XML 2.

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