Plan TOC and Submission Planning

Plan TOC and Submission Planning #

The Plan TOC Editor is a specialized workspace in DnXT Publisher designed for strategic submission planning across multiple regions. Unlike the standard TOC Editor (which works with a single dossier and its submissions), the Plan TOC Editor provides a multi-region, multi-tab interface with an integrated planner spreadsheet that enables regulatory affairs teams to coordinate complex global submission strategies. This guide covers every aspect of the Plan TOC Editor, from navigating the regional tab interface to using the planner spreadsheet for timeline and document management.

Accessing the Plan TOC Editor #

To open the Plan TOC Editor, double-click any plan in the Plan Library. The editor loads with the plan’s regional structure and any existing planning data.

Interface Layout #

The Plan TOC Editor uses a split-panel layout similar to the standard TOC Editor, but with important differences:

• Left Panel (Regions Container) — Displays the list of regions included in the plan. Click a region to open it as a tab in the right panel.
• Right Panel (Detail/Planner) — Shows the selected region’s planner spreadsheet and TOC view in a tabbed interface.

Top Menu Controls #

The top menu bar includes:

• Plan Selector Dropdown — Switch between plans without returning to the Plan Library.
• Submission Selector Dropdown — Switch between sub-plans (regional submissions) within the current plan.

Regional Tab Interface #

One of the most distinctive features of the Plan TOC Editor is its multi-tab region interface. When you click a region in the left panel, it opens as a new tab in the right panel. Each tab is independent and can be closed when no longer needed.

Opening Region Tabs #

1. In the left panel, you will see a list of all regions in the plan (for example, US, EU, JP, CA).
2. Click any region to open it in a new tab in the right panel.
3. The tab shows the region name with a close button (X) for dismissal.
4. You can open multiple region tabs simultaneously and switch between them by clicking the tab headers.

Within Each Region Tab #

Each region tab contains two views, accessible via toggle buttons:

• Planner View (P) — A spreadsheet-based planning interface.
• TOC View — The eCTD TOC tree for that region, similar to the standard TOC Editor but focused on planning rather than authoring.

Planner Spreadsheet #

The Planner is a spreadsheet-style interface within each region tab that provides a tabular view of all planned documents and their attributes. It is the primary tool for managing the planning details of a submission.

Spreadsheet Columns #

Working with the Spreadsheet #

The planner spreadsheet supports cell-level editing:

1. Click any cell to select it.
2. Double-click or press Enter to begin editing.
3. For dropdown fields (like Status or Lifecycle Operation), a dropdown selector appears.
4. For text fields, type directly in the cell.
5. Press Tab to move to the next cell, or Enter to confirm and move down.
6. Changes are saved automatically as you edit.

Right Panel Detail Buttons #

The right panel header includes three toggle buttons for switching between detail views:

TOC Editing Per Region #

Within each region tab, you can switch to the TOC view to see the eCTD tree structure specific to that region. The TOC view in the Plan TOC Editor includes the same controls as the standard TOC Editor:

• Module Filter Buttons — Filter by All, M1, M2, M3, M4, or M5.
• Expand/Collapse — Expand or collapse the tree.
• Edit TOC Toggle — Enable editing mode for the TOC.
• Bulk Exclude/Include — Select multiple sections and exclude or include them in the submission plan.

Drag and Drop in Plan TOC #

Like the standard TOC Editor, the Plan TOC supports drag-and-drop document placement. Drag files from the Content Manager onto TOC nodes to assign planned documents. In the planning context, this associates a document source with a TOC section without necessarily placing the final document.

Multi-Region Planning Workflow #

Here is a recommended workflow for multi-region submission planning:

1. Create the plan — In the Plan Library, create a plan covering all target regions.
2. Open all region tabs — In the Plan TOC Editor, click each region in the left panel to open it as a tab.
3. Plan shared content first — Identify documents that are shared across regions (typically Modules 2-5 content). Assign these documents in one region and map them to other regions.
4. Plan regional content — For each region tab, plan the Module 1 content specific to that region’s requirements.
5. Set timelines — In each region’s planner spreadsheet, set target dates for document readiness, review milestones, and submission dates.
6. Assign responsibilities — Use the Assigned To column to designate team members for each document.
7. Review and finalize — Review the plan across all regions for completeness and consistency.
8. Create dossiers — When the plan is finalized, create dossiers for each region based on the plan.

Planning Attributes #

In addition to the planner spreadsheet, each regional sub-plan can have planning attributes that capture high-level strategy information:

• Submission target date — The planned date for filing the submission with the health authority.
• Review period — The expected internal review period before submission.
• Priority level — The relative priority of this regional submission compared to others in the plan.
• Regulatory pathway — The specific regulatory pathway being used (e.g., centralized procedure for EU, 505(b)(2) for US).
• Notes — Strategic notes and comments for the team.

Access these attributes by clicking the S (Submission Details) button in the right panel header.

Frequently Asked Questions #

Can I edit the planner spreadsheet and the TOC at the same time? #

You can switch between the Planner and TOC views within a region tab, but only one view is displayed at a time. Changes made in either view are reflected in the other.

How do I close a region tab? #

Click the X button on the region tab header to close it. Closing a tab does not delete any data — you can reopen it by clicking the region in the left panel.

Can I export the planner spreadsheet? #

The planner data can be exported for reporting purposes. Check with your administrator for available export options.

What happens when I create a dossier from a plan? #

Creating a dossier from a plan generates a new dossier in the Dossier Library with the TOC structure and document assignments defined in the plan. The plan remains linked to the dossier for ongoing tracking.

Can I update a plan after dossiers have been created? #

Yes. Plans can be updated at any time. However, changes to the plan after dossier creation do not automatically propagate to existing dossiers. You will need to manually update dossiers to reflect plan changes.

Related Articles #

• Plan Library: Working with Plans — Manage plans in the Plan Library.
• Submission Authoring with the TOC Editor — Author submissions in the standard TOC Editor.
• Creating a New Dossier Plan — Create dossiers that execute the plan strategy.
• Template Library — Use templates to accelerate plan and dossier setup.