- Template Library
- What Are Templates?
- Navigating to the Template Library
- Template Library Tabs
- Template Library Toolbar
- Viewing Template Details
- Enabling and Disabling Templates
- Creating a New Template with the Template Manager
- Managing Templates
- Applying Templates to New Dossiers
- Frequently Asked Questions
- Related Articles
Template Library #
The Template Library in DnXT Publisher provides a centralized repository for managing reusable TOC templates. Templates define pre-configured eCTD Table of Contents structures that can be applied when creating new dossiers, significantly reducing setup time and ensuring consistency across submissions. This guide covers browsing the Template Library, creating new templates with the Template Manager wizard, managing existing templates, and applying templates to new dossiers.
What Are Templates? #
A template in Publisher is a pre-configured eCTD TOC structure that defines which sections are included, which modules are active, and what region-specific configurations are applied. Templates serve as blueprints for new dossiers, allowing teams to:
- Standardize submissions — Ensure all dossiers for a given region and application type follow the same TOC structure.
- Reduce setup time — Skip the manual process of configuring TOC sections for each new dossier.
- Capture best practices — Embed organizational knowledge about which sections are required, optional, or not applicable for specific submission types.
- Support compliance — Ensure that region-specific requirements are met by including the correct Module 1 structure.
Navigating to the Template Library #
Click Template Library in the left navigation panel from any screen in Publisher.
Template Library Tabs #
The Template Library has three tabs:
All Templates (Default) #
Displays all available templates in your organization. Each template card shows the template name, base region, description, and status (enabled or disabled). Templates are displayed in tile or list view depending on your preference.
Recently Viewed #
Shows templates you have recently opened or viewed, ordered by most recent access.
Favorites #
Shows templates you have marked as favorites for quick access.
Template Library Toolbar #
| Control | Description |
|---|---|
| Create Template | Opens the Template Manager wizard to create a new template. This button is permission-gated — only users with template creation permissions can see it. |
| Delete | Deletes the selected template(s) after confirmation. |
| Filter | Filter dropdowns for narrowing by region, status, and other criteria. |
| Tile/List Toggle | Switches between tile view and list view. |
Viewing Template Details #
Click any template in the Template Library (single click) to open a details panel. The details panel shows:
- Template Name — The display name of the template.
- Description — A text description of the template’s purpose and intended use.
- Base Region — The primary region the template was built for.
- Regional Templates — The specific regional TOC configurations included.
- Active Modules — Which eCTD modules (M1-M5) are included in the template.
- Status — Whether the template is enabled (available for use) or disabled.
- View TOC Button — Click to preview the template’s TOC structure without creating a dossier.
Previewing the Template TOC #
Click the View TOC button in the template details panel to open a read-only preview of the template’s eCTD structure. This shows the complete hierarchy of modules, sections, and sub-sections that will be created when the template is applied to a new dossier. Use this preview to verify the template meets your needs before applying it.
Enabling and Disabling Templates #
Templates can be enabled or disabled by administrators:
- Enabled templates are available for selection when creating new dossiers.
- Disabled templates are hidden from the dossier creation workflow but remain in the Template Library for reference and can be re-enabled at any time.
To toggle a template’s status, select it in the Template Library and use the enable/disable control in the details panel or context menu.
Creating a New Template with the Template Manager #
The Template Manager is a wizard-style interface that guides you through creating a new template step by step. Click Create Template in the Template Library toolbar to open it.
Step 1: Select a Base Template #
The first field in the Template Manager is the Base Template selector dropdown. If you want to create a template based on an existing template, select it here. The new template will inherit the base template’s structure, which you can then customize. If you want to start from scratch, select the blank template option.
Step 2: Select Regional Templates #
The Regional Template Selector displays flag icons for each supported region. Select one or more regional templates to include in your new template:
| Flag | Region | Description |
|---|---|---|
| AU | Australia | TGA Module 1 structure |
| CA | Canada | Health Canada Module 1 structure |
| CH | Switzerland | Swissmedic Module 1 structure |
| EU | European Union | EMA Module 1 structure |
| GCC | Gulf Cooperation Council | GCC Module 1 structure |
| HR | Croatia | HALMED Module 1 structure |
| JP | Japan | PMDA Module 1 structure |
| TH | Thailand | Thai FDA Module 1 structure |
| US | United States | FDA Module 1 structure |
| ZA | South Africa | SAHPRA Module 1 structure |
The selected regional templates determine which Module 1 structure is included. Modules 2-5 are the same across all regions (ICH-harmonized) but the module checkboxes control which are active.
Step 3: Select Modules #
The Module Checkboxes (M1 through M5) let you specify which eCTD modules should be active in the template. The availability of each checkbox depends on the selected regional template. At minimum, M1 is always included. Select the modules relevant to your submission type.
Step 4: Name and Describe the Template #
- Template Name — Enter a unique, descriptive name (for example, “US FDA NDA Full Template” or “EU MAA Variation Type II Template”). The name must be unique across all templates in your organization.
- Description — Enter a description that explains when and how this template should be used. This helps other users select the right template.
Step 5: Create the Template #
Review your selections and click the Create Template button. Publisher generates the template with the configured TOC structure. The new template appears in the Template Library and is immediately available for use when creating new dossiers.
Validation Rules #
The Template Manager enforces several validation rules:
- At least one regional template must be selected.
- The template name must be unique (not already used by another template).
- The template name cannot be empty.
- At least one module must be selected.
If validation fails, error messages will be displayed indicating what needs to be corrected.
Managing Templates #
Editing a Template #
To modify an existing template, select it in the Template Library and click the edit option. You can change the name, description, and enabled/disabled status. Structural changes (adding or removing regions or modules) may require creating a new template.
Deleting a Template #
Select one or more templates and click Delete in the toolbar. Confirm the deletion. Deleting a template does not affect dossiers that were already created using that template.
Adding to Favorites #
Right-click a template and select Add to Favorites for quick access from the Favorites tab.
Applying Templates to New Dossiers #
When creating a new dossier in the Dossier Library, you can select an enabled template from the template dropdown in the Create Dossier form. The new dossier will inherit the template’s TOC structure, giving you a pre-configured starting point for document placement.
Frequently Asked Questions #
Can I modify a template after dossiers have been created from it? #
Yes, but changes to a template do not retroactively affect existing dossiers. Only new dossiers created from the modified template will reflect the changes.
Can I create a template for multiple regions? #
Yes. The Template Manager allows you to select multiple regional templates. This is useful for creating templates used in multi-region plans.
Who can see templates? #
All Publisher users can see and use enabled templates when creating dossiers. Only users with template management permissions can create, edit, or delete templates.
What happens if I disable a template? #
Disabled templates are hidden from the dossier creation workflow but remain in the Template Library. They can be re-enabled at any time.
Can I import templates from another organization? #
Template import/export functionality depends on your system configuration. Contact your administrator for available options.
Related Articles #
- Creating a New Dossier Plan — Apply templates when creating new dossiers.
- Submission Authoring with the TOC Editor — Work with the TOC structure defined by templates.
- Plan Library: Working with Plans — Use templates in submission planning.
- Getting Started with Publisher — Overview of all Publisher features.
