Add File References

A file reference is an entry in the CTD Table of Contents that provides a link to a file contained in the output. Publish allows you to create file references in a variety of ways, including dragging and dropping from the file system, browsing for one or more files, and creating placeholder file references.

File references may only be added in Origin, Life Cycle, or Current view.

For many higher-level section headings in the CTD, adding file references to them is discouraged. If you attempt to add a file reference to a section that does not allow file references, you will receive a warning, if that option is enabled in Tools > Options. Please see the “Customize Publish” section for additional details.

For example, if a user tried to add a document directly into the US Module 2 Section 2.6 Nonclinical Written and Tabulated Summaries, they will receive a message similar to the following image.

This file can still be added, however a schema error will appear when running the final validation report.

Note: For US Sequences, documents for clinical and nonclinical studies are placed at a lower level section under the study number (such as “Study Protocol or Amendment” or “Demographic Data”) that is automatically generated by Publish. These sections represent Study Tagging File “File Tags”.

Study Tagging Files are discussed in the ICH document “The eCTD Backbone File Specification for Study Tagging Files” (Ref. 2), even though they are generally used only in US submissions. File tags in turn are based on clinical study report organization defined by ICH in “Structure and Content of Clinical Study Reports: E3” (Ref. 11).

See the “Clinical and Non-Clinical Studies” section for additional information on Study Tagging Files

See the following sections for more information:

DMS Window

Browse to Files

File References for XML Files

Create Placeholder File References

Publish allows you to connect to certain EDMS systems inside Publish, allowing documents to be pulled from the DMS without leaving the program. Currently, GlobalSubmit supports local shares, Amazon S3 buckets, SharePoint 2010 and 2013 shares, Documentum, and Veeva. Adding these DMS shares through Publish is a simple and quick process.

This next section will take you through the steps to configure and use the DMS trees.

Select View > Manage DMS > Manage.
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This will bring you to the Manage Screen. Click New to add the configurations required to connect to the DMS system.

Select the type of DMS System.

When OK is selected, you will be prompted to enter a name for the DMS connection.

At this point, the DMS configuration can be activated by selecting the DMS name and clicking Active, then OK. Once activated, the DMS will show in bold.

Files can now be dragged and dropped directly from DMS pane into the eCTD tree.

You can drag and drop files from Windows Explorer or the previously mentioned DMS pane to a table of contents heading in the tree view, or into the details grid with the TOC heading selected in the Navigation pane.

To add a document to the tree, select one or more files from the DMS pane or Windows Explorer and drag the files over the desired location in Publish and drop them.

The documents will now appear under the selected heading. If you drag and drop a file over an existing file reference the File Actions window is displayed.

New – Adds the file reference into the same section as the pre-existing file.

To browse to files that you want to add to the sequence, choose a section in Origin, Life Cycle, or Current view and select New > File Reference from the Manage or context menu. You will then see the Add File Reference dialog for browsing and selecting files.

You can select multiple files by holding down the Ctrl key and choosing the desired files. To select a range of files, select the first file in the range, hold the shift key and select the last file in the range.

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.

Note: Although PIM documents are XML, they are submitted in a zipped format containing all necessary files, so no special handling is needed.

A placeholder file reference marks the location in the table of contents for a file to be added later and allows properties to be entered

To create a placeholder file reference, choose a section in Origin or Life Cycle view and select Add Placeholder from the Manage or context menu.