Electronic Publish

There are a number of ways you can create electronic output. You will need to determine which options to select based on your publishing needs. These needs are likely to change throughout your submission process.

You can create different kinds of electronic output, including:
  • Leaf elements
  • eCTD XML
  • A single file

Leaf Elements

When you publish leaf elements, you create a PDF file for each standard leaf. Calyx RIM creates a file in the native format (for example, Microsoft Word) for any published leaf elements that were flagged in the assembly to use the native file. You can choose to publish a full set or a subset of leaf elements in the assembly. You can use the Leaf Status values to identify the leaf elements in an assembly that need to be published.

eCTD XML

Calyx RIM is designed to publish eCTD XML. You have the ability to publish an eCTD XML backbone independently, or in conjunction with publishing leaf elements.

Single File Output

Publishing to single file output is by its nature an electronic publish, not paper. When publishing to a single file, all electronic output including sheets (TOCs, cover pages, etc.) and documents outside of the leaf are published, with the exception of native files. If a document belongs to a native leaf, it is not be included in the single file output.

Single file report publishing to paper or electronic ignores the location from where it was run; the entire assembly is always published in these cases. A single output PDF file is created by the publishing engine. Unlike electronic or paper publishing, this option is not sensitive to the section from which the publish was executed.

Note: For single file electronic output, elements both within and without leafs are included in the published output. Only native files are excluded from the published output. The leaf statuses selected in the Publish Request page do not affect the Publish to a Single File option, all leafs are included in the published output.