XML Definition File Publishing Settings

The XML Definitions settings determine the specification that is used for publishing your eCTD submission.

The XML (eXtensible Mark-up Language) DTD (document type definition) files indicate which specification your eCTD submission should use for publishing. These files are generally associated with a specific assembly template, but submissions based on earlier versions of the specification may be updated to newer specifications by selecting the latest definition file in the Publishing Settings of the active working assembly. These files are placed in a repository that is accessible to Calyx RIM, and new ones may be added to this location as a result of a new agency or ICH (International Conference on Harmonisation) specification.

For eCTD, you typically select a regional DTD, the standard ICH DTD, and the STF (Study Tagging File) DTD. The STF DTD can be activated even if STFs are not being created, as this enables global reuse by allowing you to specify how Study folders should be processed in the XML at the module-level.

Only one DTD file for each output XML file can be assigned in the DTD settings. If more than one is assigned, an error may occur during publishing (fixpoint error). Multiple DTDs are assigned if multiple XML files are generated, for example: ICH index.xml, regional.xml, and possibly stf.xml.