The hard work’s already done. Now you’re just 1 click away from define.xml
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 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 define.xml. 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.
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.
Instantly make SDTM.define and ADaM-based define.xml from your Formedix datasets.
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.
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.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...