When it comes to clinical trial submission, one of the most significant standards is the...
Once you have finished your study, it is all about FDA submission, and that means having your study metadata in STDM define.xml format. This is quick and easy to do in Formedix. Once your metadata is in our library and you have built your study and defined your datasets, you can create define.xml with 1 click in our visual define.xml editor.
There is no need to understand code or XML. Or if it is a spreadsheet, import it into Formedix to convert. You can even convert a SAS XPT file or old legacy datasets.
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. This minimises the future effort needed to create define compliant metadata – you know that compliance will be incorporated into your dataset design by default.
Creating Define-xml metadata
Easily create dataset metadata specifications in Formedix. To make things easier, we have embedded the Define-XML standards into the dataset design process so you will always be compliant.
SDTM, SEND, ADaM, & ARM
We have incorporated SDTM, SEND, and ADaM into an easy to use define structure. All aspects of the define.xml are captured, 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 have given you the tools to describe ARM for a study. This is just 1 example of how we help you work with new standards very quickly.
You can check SDTM and ADaM datasets for non-compliance with Define-XML standards. So it is easy to create valid, consistent Define-XML metadata in Formedix. And it is just 1 click to generate your submission ready define.xml.
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 visualise 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 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.
What about updates to CDISC standards?
We quickly integrate any updates to standards across our platform. And we continue to support previous versions of standards so that you have got the flexibility to create define.xml in whatever version you need.
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