Before getting into the specifics of version 2.0 of Define-XML, let’s first take a look at some background information about define!
What is Define-XML and why is it important?
CDISC’s Define-XML is a document that describes the structure and content of data collected in a clinical trial process. Define-XML is extremely important in clinical trials and is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The FDA’s Technical Conformance Guide explains that Define-XML is "arguably the most important part of the electronic dataset submission for regulatory review” because it helps reviewers gain familiarity with study data, its origins and derivations.
Define-XML version 2.0
Define-XML v2.0 represents a significant update from the previous version and was developed in response to implementation experience with v1.0, the evolution of the SDTM, SEND and ADaM standards and best practices by SDTM and ADaM metadata experts.
Differences between Define-XML v1.0 and v2.0
Define-XML 2.0 introduces many improvements over the original, which are summarized in Figure 1 below. These changes are focused around improving value level metadata, linking to CDISC/NCI Controlled Terminology standards and linking to annotated CRFs. The new version also removes ambiguity and provides improved support for ADaM metadata.
The Formedix clinical metadata repository and study automation platform supports Define-XML v2.0 and lets you create Define-XML documents in 1 click!
Looking to discuss CDISC Define-XML? Speak to us!
The Formedix team has always been a strong advocate for the use of CDISC data standards in clinical and non-clinical research and has become industry leader in CDISC software.
In fact, we’re on the CDISC XML technical team! We were involved in creating the CDISC ODM and Define models. So we know a fair bit about CDISC standards.