Modify Content

Content is often getting updated, even after addition to the eCTD tree. Publish allow for simple and quick updating of documents as details and content changes. The following sections explains a few ways to do so through the Publish platform.

Modify PDF Text from Publish

Set Titles

Edit File Names

Overwrite Files

As a publisher there will be times when slight changes may be required, such as typographical errors, incorrect styling of a section, modification of text color, etc., but may not require a complete overwrite of the document, as mentioned in the “Overwrite Files” section. To make this process less arduous, Publish allows for direct modification of text from the GlobalSubmit output, while keeping audit trails intact.

Note: In order to modify a PDF document, a version of Adobe Acrobat (Standard or Professional) is required.

To modify the text of a PDF document, find the document in the Navigation pane. In this example, the debarment document has a spelling error.

Double-click to check out the document from the Navigation pane and open it in Adobe Acrobat, while still maintaining the audit trails for document modification.

After completing the modifications, click Save and close the window.

In the Tools > Status window, an update occurs, and the application is updated with the new version of the document.

A leaf title, used interchangeably in this guide with title, identifies each file reference in the table of contents when an application is viewed. This title is the primary means of document identification for an agency reviewer, therefore it must be clear, accurate, and convey the main point of the document prior to viewing the content.

As each file is added, it will receive a default title based on the title rules that have been defined for your sequences. If multiple files have the same title in a given section, a warning message will appear.

To change a file reference’s title, locate the file reference in the Details or Inventory grid and click on the title field, where an entirely new value can be added. By default, the sequence number will be located next to the file title, for ease of use when lifecycling documents.

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If a title duplicates the title of another file reference in the same section, a warning message will appear. If this is not resolved prior to submission, a validation error will appear when running the validation report through GlobalSubmit Validate.

Additional information on titles can be found in the “Manage Standard File Reference Titles” section.

The file name is the name of the physical file contained in the output of the submission. It is the actual document referenced in the indices. Agency reviewers do not normally see this file name, but automated programs and the xml coding expect certain naming conventions to be followed.

Publish applies standard naming rules as files are migrated from the original storage location to the published output location. For additional details, please see references 1, 4, 8, and 10. Publish also automatically ensures that file names are ICH compliant. This includes: all lower-case letters and numbers, no spaces, etc.

However, there are a few instances where Validate does not have enough information to set the file name and the name may need to be updated manually to comply with various agency rules and recommendations, as shown in the table below.

Note: This list may not be comprehensive and internal quality checklists should provide further details.

To manually change a file reference’s file name, locate the file reference in the Details or Inventory grid and click on the file name field. New file names can be added, subject to the following rules:

Note: File extensions, such as .pdf or. xpt, cannot be modified after the document has been added to GlobalSubmit. If the file type is wrong, the correct file must be added and the incorrect one removed before submission.

​You cannot change a file name until the file has been copied to the published output location. Changing the file name only affects the file in the published output area. The file name in the original location will not be modified.

If an incorrect document was added to a submission, or a document has been updated after adding to Publish, the file reference will need to reference a different physical file. Placeholders will also need to be populated with appropriate content once the content becomes available.

To overwrite a file with new content, select a file reference in an In Progress sequence in the table of contents and choose Update File from the Manage or context menu.

The previous leaf title will remain as the leaf title of the previous document in the Navigation pane by default.

This file reference can be renamed manually if the document was added incorrectly or the name needs updating.

Note: Replacing content is different than using the eCTD operator Replace, which is discussed in the “Manage Lifecycle” section.

Reused file indicator —

A physical file can be referenced by more than one file reference when copied to multiple locations. This is known as a reused file in GlobalSubmit. Agencies using eCTD prefer the reused file instead of adding new physical files, as this saves on disk space and loading times for submissions. When reused files are added, the application must be successfully processed in Publish before they will be recognized as reused files in Review.

When attempting to overwrite files that are referenced by more than one file reference, a popup appears asking if the replace is only for the selected file reference or if this is for all referencing file references.

If other referenced file references are in unreserved sections, another popup will appear, requesting to reserve the other sections.

If, in the case that the other sections cannot be reserved, an error message will appear