Working with Hyperlinks in RIM Submissions Publishing

Hyperlinks within eCTD submissions are a vital navigation aid for reviewers of submitted content, and missing hyperlinks can result in a slower approval timeline.

Within Submissions Publishing, you can manage hyperlinks using:

Creating & Navigating Link Annotations

Submissions Publishing leverages Vault’s link annotation functionality by converting link annotations and MS Word links to standard relative PDF links upon publishing. This allows you to create cross-reference links within Vault once documents are finalized, outside the context of a submission.

When you create a link annotation and select multiple targets of the same type (for example, permalinks only or anchors only), Submissions Publishing determines the most appropriate target, based on the logic outlined in Link Publishing.

This can be useful, for example, when the same source document is used in multiple regions, but the target document differs from region to region.

When you create a link to Submissions Archive Content-type documents that were imported or published previously, the following must be true in order for Vault to publish links correctly:

  • The Actual Submission Date field must be set on the target document’s related Submission record.
  • The Dossier Status field on the target document’s related Submission record must not be set to Publishing Active.

While authoring submission content, you can create document permalinks within the source document that navigate users to other content within Vault. Cross-document links in MS Word documents can persist even as content changes during the authoring process. See Using Dynamic Linking for more information.

RIM can compare Keyword statements and other product information to automatically suggest and create link annotations to relevant reference materials via the Suggest Links action. There are four ways to link to a Keyword:

  • Suggested Links: When you click the Suggest Links button on a document, Vault generates Suggested Links which you must review and accept or reject.
  • Approved Links: When you accept a pending Suggested Link, it becomes an Approved Link.
  • Auto Links: When you click the Suggest Link button on a document, Vault generates Auto Links for exact text matches, which do not require review or approval. Your Admin may disable Auto Links.
  • Keyword Links: When creating link annotations on documents with non-text content, such as embedded images or on video documents, you can select the Keyword type to manually create a link to a single approved, matching Keyword and its references.

You can automatically generate links for some document types. The Suggest Links button appears at the top of the Doc Info page when:

  • You have Annotate and Edit Relationships permissions on the document.
  • Suggested links have not yet been generated by clicking the Suggest Links button.
  • There is at least one matching approved Keyword.

Vault notifies you if the Suggest Links action fails or takes longer than three (3) minutes. When the Suggest Links action is complete, the Suggest Links button becomes the Suggested Links button and you will see a notification.

Reviewing & Accepting Suggested Links

When the Suggest Links action is complete, click refresh in the notification or click the Suggested Links button to open the Suggested Links view. Once generated, suggested links appear to the right of the document. Click a Suggested Link to view it, then click Accept to add the link or Reject to reject the suggestion. You can also hover over the name of the document in the Suggested Link for more information, or click the name to open the document. To view the Keyword record that Vault used to generate the suggested link, click its name in the From field. If you select a target or document type that is disabled by your Admin after you open the Select Anchor dialog, you will receive an error message.

When you accept a Suggested Link, Vault creates an Approved Link annotation. You cannot move, add, or remove references from the resulting Approved Link annotation, and these options will not appear in the annotation toolbar. Accepting a Suggested Link triggers continuous publishing.

Vault displays the related Keyword records for all Suggested and Approved Links in Pending and Approved status in the Keywords section of the document fields panel. Hover over the Keyword’s name for details, or click it to go to the Keyword’s record detail page. If you reject all Suggested Links for a Keyword, it no longer appears in this section.

In cases where there is an exact text match or a wildcard, Vault creates an Auto Link annotation authored by the user performing the Suggest Links action. Auto links are similar to Suggested Links, but, depending on your Vault’s configuration, Vault may add the resulting annotations without requiring approval. You cannot move Auto Links or edit their references; however, an Auto Link’s author can edit its comments and tags and delete the annotation. Vault displays the related Keyword records for all Auto Links in the Keywords section of the Doc Info panel.

Manually Linking to Keywords

Vault does not generate links for non-text content. You can add Keyword links to documents manually if manual linking to Keywords is enabled in your Vault, the document has a viewable or video rendition, and the Suggest Links action is enabled for the doctype. To add links to Keywords manually:

  1. Click the View annotations button to enter annotation mode.
  2. Select the link cursor mode.
  3. Select Keyword from the drop-down. If your Admin has changed the label for the annotation_keywords__sys object in your Vault, you will see this label in the drop-down instead.
  4. Highlight the area or text to place the link to open the record picker dialog containing all Approved Keywords you have permission to view. Vault auto filters these Keywords based on matching fields.
  5. Select the desired Keyword, then click Close to create the annotation. If you close the record picker dialog without making a selection, Vault does not create the link annotation.

Vault displays the related Keyword records for Keyword Links added manually in the Keywords section of the Doc Info panel, and documents containing Keyword Links appear in the Where Used panel of a Keyword record detail page. You must be in a document role with Annotate and Edit Relationships permissions to manually link to Keywords.

When adding links to a document, it is possible to create a link to an anchor elsewhere within the same document and version. However, Vault prevents you from creating whole-document links to the same document version. Therefore, some situations may result in a Suggested Link or Auto Link that does not include a link component for that reference in the resulting annotation. For example, Document A is the only reference for Keyword 001. If Jane performs the Suggest Links action on Document A, the resulting annotation contains only a link to Keyword 001 and does not contain a link to Document A.

Additionally, if a user creates a Keyword Link by selecting a Keyword that references the same document version at the document level, Vault does not include a link component for that reference in the resulting annotation. For example, if Document A contains a PDF file, and Jane creates a Keyword Link and selects Keyword 001 in the record picker dialog, the resulting annotation contains only a link to Keyword 001 and does not contain a link to Document A.

To undo the Suggest Links action and delete all Suggested Link and Auto Link annotations from a document:

  1. Click the View annotations button to enter annotation mode.
  2. Click the Remove Suggested Links button.
  3. In the pop-up dialog, click Continue.

This action removes all Suggested Links and Auto Links from a document, but does not prevent other users with the correct permissions from using the Suggest Links action on the document in the future.

Keyword Linking Limitations

The following limitations apply to Keyword Linking:

  • Vault cannot create Suggested Links on non-text content.
  • Suggested Links in Pending status cannot find Match Text that spans across multiple pages.
  • Suggested Links in Pending status do not appear in PDF With Annotations or Export Annotations downloads.
  • You cannot download Suggested Links in Pending status with the Download Notes action.
  • You cannot run the Suggest Links action or accept pending links on archived documents. Note that removing pending links is allowed.
  • Vault does not bring forward Suggested Links in Pending or Approved status or Auto Links.
  • When using the Make a Copy action on a document, Vault temporarily shows pending Suggested Links, Approved Links, and Auto Links in the unsaved new document. These annotation types are not copied to the new document once it is saved. Manual Links and Keyword Links are copied to the new document when using the Make a Copy action.
  • When using the Make a Copy action on a document with Approved Link or Auto Link annotations, Vault does not copy the associated linked document relationships unless Include Linked Document relationships from Auto Links is enabled for your Vault. Contact Veeva Support to enable this feature.

During publishing, Vault:

  • Compiles the link annotations and dynamic links within the document and converts them to standard PDF links with relative paths to the target documents, determined by the Published Output Location (xml_xlinkhref__v) field within the same submission and application.
  • Includes the application and sequence folder in the link path, if your documents include links to Submission Archive Content-type documents that were previously published or imported.
  • Links to the latest possible version of the target document in the current submission, unless the link annotation or URL targets a specific document version.
  • Searches prior eCTD submissions in the current application if the target document doesn’t exist within the current submission. If the target document doesn’t exist in either location, Vault creates links to documents in a different submission as long as the application has the same Lead Market, Health Authority, and Healthy Authority Division, and the Allow Cross Application Linking field is set to Yes on the Country record selected as the lead market.
  • Resolves dynamic and keyword links based on the Source for Published Document when set to a Custom Rendition, such as the Publishable Rendition. Vault link annotations are resolved only when this field is set to Viewable Rendition.

Vault also supports cross-application PDF links, allowing users to navigate easily to referenced pages within a target document.

During the publishing process, Vault also converts permalinks created with copied Bookmark or Destination links in Vault to standard PDF hyperlinks with relative paths based on the Published Output Location (xml_xlinkhref__v) field on the Content Plan record.

  • Vault ignores link annotations created in the source Vault when publishing CrossLink documents.
  • During publishing, Vault renders all links to display in blue text, even if this setting isn’t enabled in your Vault.