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Reviewing Submissions with TOC

The Table of Contents (TOC) view is where you spend most of your time in Reviewer. It is a three-panel workspace that lets you browse the eCTD structure, view documents, and manage annotations — all in one screen.

TOC View — three-panel layout with tree, document viewer, and annotations sidebar

TOC View — three-panel layout with tree, document viewer, and annotations sidebar

Accessing the TOC View #

  1. Click Dossier Library in the sidebar.
  2. Find the dossier you want to review.
  3. Double-click the dossier to open it.
  4. The TOC view loads with the submission’s eCTD tree in the left panel.

Understanding the Three-Panel Layout #

Panel Position Purpose
TOC Tree Left The eCTD folder structure. Expand/collapse nodes to navigate sections and documents.
Document Viewer Center Displays the selected document (PDF, Word, Excel, XML, images, etc.)
Annotations & Links Right Lists all annotations and link tasks for this submission. Filter by assignee, status, or creator.

Navigating the TOC Tree #

Module Filter Buttons #

Above the tree, a row of filter buttons lets you show only specific modules:

Button Shows
All The complete tree (all modules)
M1 Module 1 only — Administrative documents
M2 Module 2 only — Summaries
M3 Module 3 only — Quality
M4 Module 4 only — Nonclinical
M5 Module 5 only — Clinical
STF Study Tagging Files
Tip: Use module filters when you are only responsible for reviewing one module. For example, a CMC reviewer can click M3 to see only quality documents, hiding the clinical sections entirely.

Searching the TOC #

Type in the Search TOC field above the tree to find sections or documents by name. Matching nodes are highlighted. Use the up/down arrows next to the search field to jump between matches. The match count shows how many results were found (e.g., “3 of 7”).

Expand and Collapse #

Click the +/− button to expand or collapse all nodes at once. Right-click any node for options like “Expand to Level 2” or “Collapse All.”

View Modes #

A dropdown above the tree lets you change how the tree is organized:

Mode What It Shows
Dossier View The standard eCTD hierarchy (Module → Section → Document). This is the default and most common view.
Folder View A filesystem-like view showing the actual folder structure on disk
File View A flat list of every file in the submission, regardless of hierarchy. Useful for finding a specific file quickly.

Current vs. Cumulative View #

Two radio buttons at the top of the workspace control which documents you see:

Mode What It Shows When to Use
Current Only documents from the selected submission (sequence). This is one point-in-time snapshot. When you need to review exactly what was filed in a specific sequence.
Cumulative The merged view across all sequences — shows the latest version of every document. Superseded documents are replaced by their newer versions. When you want to see the current state of the entire dossier, incorporating all amendments and supplements.
Note: In Cumulative view, the tree may show more nodes than in Current view because it merges documents from all sequences. If a document was included in sequence 0001 and updated in sequence 0003, Cumulative shows the 0003 version.

Dossier and Submission Selectors #

At the top of the TOC view, two selectors let you navigate between dossiers and submissions:

Dossier selector — Switch to a different dossier without going back to the library. Useful when comparing submissions across dossiers.

Submission selector — Switch between sequences within the same dossier (e.g., from sequence 0001 to 0003). The tree reloads to show the selected submission’s contents.

Submission Status and Workflow #

The status badge at the top shows the current review status of the submission (Draft, In Review, Approved, etc.). If your role allows it, click Change Status to advance the submission to the next workflow state.

The lock icon next to the submission name indicates whether the submission is locked (read-only) or unlocked (editable). Locked submissions cannot have new annotations added.

Viewing Document Properties #

When you select a document in the tree, two additional tabs appear below the viewer:

Document Properties — Shows metadata like document title, file type, size, and eCTD leaf attributes.

Document Lifecycle — Shows the history of changes to this document across submissions (when it was added, replaced, or deleted).

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