Generating Define-XML and PDF

CDISC Define-XML is the industry standard model for describing datasets, and is now a regulatory requirement for submissions

Whether your datasets are designed in Formedix On or elsewhere, it's a simple step to publish Define-XML metadata for them. Publishing the Define-XML as a fully bookmarked PDF file is also simple, making it easy to include this in your submission to help the reviewer.

Generating Define-XML from Formedix On datasets

Once your datasets have been designed in Formedix On, simply export a Define-XML.

Generating Define-XML from an Excel spreadsheet

If you prefer to define your datasets in a spreadsheet you can use our Convert Excel to Define-XML On Demand Service to turn it into a Define-XML.

Generating Define-XML from SAS Transport files

Where you have existing datasets as SAS Transport v5 files (XPT) you can use our Convert SAS XPT to Define-XML On Demand Service to generate a detailed Define-XML. Value lists are automatically generated from the data. Terminologies can be generated from the data or merged from a spreadsheet. This is ideal for generating regulatory-compliant metadata for legacy studies.

Generating Define.PDF or HTML

Define-XML is great, but it can be hard for people to understand the content. To simplify things you can use our Publish Define-XML as PDF or Publish Define-XML as HTML On Demand Services to generate a file that makes everything clear for people who don't understand the XML. This is typically included along with a submission to make the dataset metadata easily visible to the reviewer.

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Formedix On is a powerful platform designed to accelerate your clinical trials and drive data quality through the standardization and reuse of metadata. It is based on CDISC standards, facilitating regulatory compliance with the FDA, PMDA, EMA and other regulators.

With Formedix On you can:

Support for industry standards such as SDTM, ADaM, SEND, Define-XML, Analysis Results Metadata, Dataset-XML and ODM comes built in. In fact, Formedix have been active members of CDISC since 2001 and our products are CDISC certified.