Sequences may contain XML documents for certain special purposes, most commonly Structured Product Labeling (SPL) in the US, define.xml in the US and the Electronic Application Form (eAF) XML application forms for EMEA. These XML documents reference other files, including some files that should not be linked to the backbone (such as images and stylesheets). PUBLISH provides some special handling for specific XML documents added to a sequence. This handling is described in the following table; if other XML documents are included, no special handling is provided.
Document | How does PUBLISH Identify? | What Does PUBLISH Do? |
|---|---|---|
define.xml | Document contains the line: | PUBLISH automatically copies the stylesheet associated with the define.xml file into the same location as the define.xml file. It is the responsibility of the publisher to add other referenced files such as SAS transport files and blank CRFs as file references in the application. |
SPL | Document contains the line: | PUBLISH will locate anything marked as observationMedia (images) and copy it to the correct location. There is no need to add the images as file references, as they are added to the output automatically by PUBLISH. |
eAF (new applications) | Document indicates that dtd = eu-application.dtd | When publishing occurs, PUBLISH will place the standard dtd and respective stylesheet in the m1 and util folders, per guidance. |
eAF | Document indicates that dtd = eu-renewal.dtd | |
eAF | Document indicates that dtd = eu-variation.dtd |
Note: Although PIM documents are XML, they are submitted in a zipped format containing all necessary files, so no special handling is needed.
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