Creating and Managing Hyperlinks

Creating and Managing Hyperlinks #

Hyperlinks are a critical component of eCTD submissions. They enable health authority reviewers to navigate between related documents within the submission — jumping from a summary in Module 2 to the full study report in Module 5, for example, or linking a clinical overview to its referenced tables and figures. DnXT Publisher provides a comprehensive hyperlink management workflow that includes creating links, copying and pasting link references, validating link integrity, and obtaining approvals before publishing.

Understanding eCTD Hyperlinks #

In the eCTD format, hyperlinks serve as cross-references between documents within a submission. They are embedded in the PDF documents and referenced in the eCTD backbone XML. There are several types of hyperlinks commonly used in eCTD submissions:

Creating a New Hyperlink #

Creating a hyperlink in Publisher involves identifying the source document (where the link originates) and the target document (where the link points to). Follow these steps:

Step 1: Select the Source Document #

1. Open the dossier in the TOC Editor.
2. Navigate to the TOC node containing the source document — the document from which you want to create a link.
3. Click the node to select it.

Step 2: Open the Hyperlink Manager #

1. In the right panel, locate the Hyperlinks section of the Node Details view.
2. Click the Add Hyperlink button to open the hyperlink creation dialog.

Step 3: Select the Target #

1. In the hyperlink creation dialog, browse the TOC tree to locate the target document — the document you want to link to.
2. Click the target node to select it as the link destination.
3. Optionally, specify a bookmark within the target document if you want to link to a specific page or section within the PDF.

Step 4: Configure Link Properties #

• Link Text — The text in the source document that will serve as the clickable hyperlink. This is typically auto-detected from the PDF content.
• Target Path — The relative eCTD path to the target document. Auto-populated based on your target selection.
• Bookmark — Optional. A named destination within the target PDF for deep linking.

Step 5: Save the Hyperlink #

Click Save to create the hyperlink. The link is now recorded in the eCTD backbone XML and associated with the source document. A hyperlink indicator will appear on the source TOC node.

Copy and Paste Link References #

Publisher supports a copy-and-paste workflow for creating hyperlinks efficiently when you need to create many links to the same target or similar targets:

1. Copy — Right-click a TOC node that has a placed document and select Copy Link Reference. This copies the eCTD path information for that document to your clipboard.
2. Paste — Navigate to the source document where you want to create the link. In the hyperlink creation dialog, click Paste Target to populate the target path from the clipboard.

This workflow is significantly faster than browsing the TOC tree to find the target each time, especially when creating multiple links to documents in the same module or section.

Link Validation #

Before publishing, all hyperlinks in the submission must be validated to ensure they point to valid target documents and that the link paths are correctly formatted. Publisher’s validation engine checks for:

• Broken links — Links that point to documents that do not exist or have been removed.
• Incorrect paths — Links with malformed eCTD relative paths.
• Missing bookmarks — Links that reference named destinations that do not exist in the target PDF.
• Circular references — Links that create loops between documents.
• Cross-sequence link integrity — Links to prior sequences that reference replaced or deleted documents.

To validate links, use Actions > Validate Submission in the TOC Editor. The validation report will include a dedicated section for hyperlink issues, categorized as errors (must fix) and warnings (should review).

Link Approval Workflow #

In many organizations, hyperlinks go through an approval workflow before a submission can be published. This ensures that cross-references have been verified by a second pair of eyes. The approval process works as follows:

1. The link creator creates hyperlinks as described above.
2. The links are automatically routed to the designated approver (configured in the workflow settings).
3. The approver sees the pending link approvals on their Dashboard (Tasks tab, Pending Approvals section) and can also access them through Dashboard > Approve Links quick action.
4. The approver reviews each link, verifying that the source and target are correct.
5. The approver clicks Approve or Reject for each link.
6. Rejected links are returned to the creator with comments for correction.
7. All links must be approved before the submission can proceed to publishing.

Managing Existing Hyperlinks #

Viewing Links for a Document #

Select a TOC node and look at the Hyperlinks section in the Node Details panel. You will see a list of all outgoing links (links from this document) and incoming links (links pointing to this document from other documents).

Editing a Hyperlink #

Click on any existing hyperlink in the list to open it in the edit dialog. You can change the target document, update the bookmark, or modify the link text. Save your changes when done.

Deleting a Hyperlink #

To remove a hyperlink, select it in the hyperlinks list and click the Delete button. Confirm the deletion in the dialog. The link will be removed from the eCTD backbone XML.

Best Practices for Hyperlinks #

• Create links systematically — Work through documents in order (Module 2 first, then Module 3, etc.) to ensure comprehensive coverage.
• Use bookmarks for large documents — When linking to a specific section within a large PDF, always use bookmarks for precise navigation.
• Test links before publishing — Use the Document Viewer to click through links and verify they navigate to the correct location.
• Document your link strategy — For complex submissions, maintain a cross-reference matrix that maps source documents to their link targets.
• Run validation frequently — Do not wait until the end of the authoring process to validate links. Run validation periodically to catch broken links early.

Frequently Asked Questions #

How many hyperlinks can a document have? #

There is no limit to the number of hyperlinks per document. Complex Module 2 summary documents may have dozens or even hundreds of cross-references.

Can I link to documents in a different dossier? #

No. eCTD hyperlinks are limited to documents within the same dossier (and its submissions). Cross-dossier references are not part of the eCTD specification.

What happens to links when I replace a document? #

When you replace a document using the Replace lifecycle operation, existing incoming links (links from other documents pointing to the replaced document) are automatically updated to point to the new version. Outgoing links within the replaced document, however, need to be recreated in the new PDF.

Can I create links to external URLs? #

External URL links (links to websites or resources outside the eCTD package) are generally not permitted in eCTD submissions. Publisher enforces this restriction.

Who can approve hyperlinks? #

Hyperlink approval permissions are configured by your system administrator. Typically, team leads, quality reviewers, or designated approvers have this permission.

Related Articles #

• Submission Authoring with the TOC Editor — Navigate the workspace where links are created.
• Adding and Managing Documents — Place the documents that links connect.
• Validating and Publishing — Validate links as part of the publishing process.
• Document Lifecycle and Status — Understand how lifecycle operations affect links.
• Dashboard Overview — Access the link approval queue from the Dashboard.