Document Viewing and Annotations

Overview #

The Document Viewer is the right-panel component of DnXT Reviewer’s TOC view, providing a full-featured environment for reading, analyzing, and annotating regulatory documents. When you click a leaf-level document in the TOC tree, it opens in the viewer with support for multi-tab browsing, document properties inspection, lifecycle tracking, and a comprehensive annotations and links system. This guide covers every aspect of the document viewing experience and the annotation workflow.

Opening Documents #

Documents open in the viewer when you click a leaf-level node in the TOC tree. The viewer automatically detects the file type and renders it appropriately:

Multi-Tab Document Browsing #

The document viewer supports multiple open documents simultaneously through a tabbed interface. Each time you click a new document in the TOC tree, it opens in a new tab within the viewer panel.

Tab Features #

• Tab labels — Each tab shows the document name. Hover over a tab to see the full file path in a tooltip.
• Active tab indicator — The currently displayed document’s tab is highlighted.
• Close individual tabs — Click the X icon on any tab to close it.
• Scroll arrows — When many tabs are open and the tab bar overflows, scroll arrows appear at the left and right edges of the tab bar. Click these arrows to scroll through the tab list.
• Switch between tabs — Click any tab to bring that document to the front.

Document Viewer Controls #

Below the tab bar, the viewer provides document-specific controls depending on the file type. For PDF documents, the standard controls include:

• Zoom In / Zoom Out — Increase or decrease the document magnification
• Fit Width / Fit Page — Automatically scale the document to fit the viewer width or show the entire page
• Page Navigation — Page number input, previous/next page buttons, and a page count indicator
• Search — Find text within the current document
• Download — Download the original document file to your local machine

Right Panel Toggle: Node Details vs. Document Viewer #

The right panel of the TOC view can display either the Node Details (metadata for the selected tree node) or the Document Viewer (the actual document content). A toggle at the top of the right panel lets you switch between these two views:

• Node Details — Shows the section heading, eCTD path, and metadata for the selected node
• Document Viewer — Shows the rendered document content with viewer controls

When you click a leaf-level document, the panel automatically switches to the Document Viewer. To return to Node Details, click the toggle or select a non-leaf node in the tree.

Document Properties Tab #

Below the document viewer (or accessible via a tab), the Document Properties panel displays detailed metadata about the currently selected document:

• Document title as defined in the eCTD XML backbone
• File name and file path within the submission
• File size and format
• Leaf ID and XML ID references
• Checksum (MD5 hash for integrity verification)
• Operation type (New, Replace, Append, Delete)
• Modified date if available

Document Lifecycle Tab #

The Document Lifecycle tab shows the complete history of a document across all submission sequences. For each version of the document, the tab displays:

• Sequence number where the operation occurred
• Operation (New, Replace, Append, Delete)
• Submission date
• File name for that version

This lifecycle view is invaluable for understanding how a document has evolved across multiple submissions.

STF Properties and Lifecycle Tabs #

For documents that have associated STF (Submission Text File) metadata, two additional tabs are available:

• STF Properties — Displays the STF metadata fields such as manufacturer name, substance name, dosage form, and other structured data extracted from the STF XML.
• STF Lifecycle — Shows the history of STF metadata changes across sequences, similar to the Document Lifecycle but specific to STF attributes.

Annotations Panel #

The Annotations panel is accessed via the right sidebar of the TOC view. It provides a comprehensive system for creating, managing, filtering, and exporting review annotations.

What Are Annotations? #

Annotations are review comments, questions, observations, or approval notes attached to specific documents within a submission. They serve as the primary communication and tracking mechanism during the review process.

Viewing Annotations #

Click the Annotations tab in the right sidebar to see all annotations associated with the current submission. Each annotation entry shows:

• Annotation text (comment content)
• Author (who created the annotation)
• Date created
• Status (Open, Resolved, Closed)
• Assigned To (if the annotation is assigned to a specific reviewer)
• Associated document name

Creating Annotations #

1. Open a document in the viewer.
2. Click the Add Annotation button in the Annotations panel (or use the annotation tool overlay on the document, if available).
3. Enter your annotation text.
4. Optionally set the Assigned To field to route the annotation to a specific team member.
5. Optionally set the Status (Open, In Review, etc.).
6. Click Save to create the annotation.

Filtering Annotations #

The Annotations panel provides multiple filter options to help you find specific annotations:

Exporting Annotations #

Click the Export button at the top of the Annotations panel to download all annotations (respecting active filters) as a CSV file. The export includes all annotation metadata: text, author, date, status, assigned user, and associated document information.

Links Panel #

The Links panel, also accessed from the right sidebar, manages cross-document references within and across submissions.

What Are Links? #

Links are cross-references that connect documents within a dossier. For example, a clinical study report in Module 5 might link to its summary in Module 2. Links help reviewers trace relationships between related content.

Viewing and Managing Links #

The Links panel displays all links associated with the current submission. Each link entry shows:

• Source document and target document
• Link type and description
• Creator and creation date
• Status (Active, Pending Approval, Broken)

Filtering Links #

Like annotations, links can be filtered by:

• Assigned By — Filter by who created the link
• Assigned To — Filter by who the link is assigned to for review
• Status — Filter by link status

Exporting Links #

Click the Export button in the Links panel to download all links as a CSV file.

Keyboard Shortcuts #

The document viewer supports several keyboard shortcuts for efficient navigation:

Frequently Asked Questions #

Can I annotate directly on the PDF? #

Depending on your instance configuration and the feature flag settings, you may be able to place annotation markers directly on the PDF page. If this feature is not available, annotations are created through the Annotations panel and are associated with the document as a whole.

How do I see annotations from other reviewers? #

The Annotations panel shows all annotations for the current submission by default. Use the Assigned By filter to show only annotations created by a specific user, or leave filters clear to see all annotations from all reviewers.

Can I edit or delete annotations after creation? #

Yes. You can edit your own annotations by clicking on them in the Annotations panel and modifying the text or status. Deletion may be restricted depending on your user role and the annotation’s status (e.g., resolved annotations may require admin privileges to delete).

What happens to annotations when I switch submissions? #

Annotations are tied to specific documents within specific submissions. When you switch to a different submission using the dropdown, the Annotations panel updates to show annotations for the new submission’s documents.

Can I compare two documents side by side? #

While the standard document viewer shows one document at a time (with tab switching), the Labeling History report provides a dedicated side-by-side comparison feature for tracking changes between document versions. See Labeling History Report.

Related Articles #

• Reviewing Submissions with TOC — Navigating the TOC tree
• Dossier Library — Finding dossiers to review
• Labeling History Report — Document version comparison and analysis
• Chronology Report — Submission timeline and history