Define-XML transforms metadata for SDTM, SEND, and ADaM datasets into an XML file that can be submitted to the FDA with each study submission. This file outlines the datasets, variables, controlled terms, and other specified metadata utilized, providing regulatory authorities essential  information. The eClinical team uses Define-XML to generate a file from a study specification, ensuring alignment with the selected Define-XML version during study configuration.

Who can use Define-XML?

While elluminate users with Importer and View privileges have access to this module, only eClinical users with Admin and View privileges should use Define-XML.

What are the benefits of Define-XML?

Provides the ability to generate a Define-XML file from a predefined specification template.

Important: Contact eClinical Solutions Support or your elluminate Project Manager for more details.