When new sequences are created through the Application Wizard, the basic Table of Contents (TOC) is automatically created, based on regional and ICH guidance. PUBLISH provides a publisher with a visual representation of the entire TOC, easily allowing a user to add content to the submission. All standard sections in the CTD are present as long as the Display Empty Sections option is enabled.
To toggle between displaying and hiding empty sections:
Choose Options from the Tools menu.
Check or clear the check box next to Show Empty Sections.
Or
Toggle empty sections on and off using Show Empty Sections button.
Once this is completed all sections that did not have data will be removed from the tree throughout all views.
Sections that do not contain any content show as a grey leaf title, as shown below:
The following image shows the list as it appears when empty sections are hidden.
Note: When the sequence is published, only the sections of the TOC that contain content will be created in the final XML backbone, in accordance with ICH guidelines.
In the next sections, we will explain how to add sections that will further define the standard sections of the CTD and how to create Section (Node) Extensions in accordance with regional guidance to provide additional levels of organization and granularity.
Repeatable Sections and/or Studies
Adding Application Metadata Repeatable Sections
Section Administration
Non-STF Study Node Extensions
Managing Content in a Sequence
Adding File References
Modifying Content
Moving File References
Copying File References
Removing File References
Managing Lifecycle
Removing a Sequence