Using Scientific Statements

Organizations use scientific statements as a foundation for scientific communications. Statements may explain efficacy, safety, disease states, unmet needs, and other themes related to current medical solutions. Vault Medical allows Medical Affairs teams to create, reference, approve, and maintain scientific statements at scale while linking them to documents that include them within the document content.

Vault Medical suggests and creates link annotations to scientific statements, and the relevant reference material, via the Suggest Links action. There are four types of Scientific Statement link annotations:

  • Suggested Links: When a user clicks the Suggest Links action (), or when the Suggest Links entry action runs, Vault creates Suggested Links, which must be reviewed and accepted or rejected.
  • Approved Links: When you accept a pending Suggested Link, it becomes an Approved Link.
  • Auto-Accepted Links: When a user clicks the Suggest Links action (), or when the Suggest Links entry action runs, Vault generates Auto-Accepted Links for exact text matches, which do not require review or approval. Your Admin may disable Auto-Accepted Links.
  • Manual Links: You can manually select approved Scientific Statements based on matching fields. You must have at least one (1) approved Scientific Statement with the same Primary Product and PrimaryCountry as the given document to manually link to a statement.

When configured by an Admin, you can click the Suggest Links user action () to trigger the Suggest Links functionality. The Suggest Links action appears at the top of the Doc Info page or as a user action when:

  • Your Admin has enabled the Suggest Links action on the document type.
  • Your Admin has added the Suggest Links entry action to a document’s lifecycle state.
  • 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 Scientific Statement.

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. The Suggest Links action can generate Suggested Links, Auto-Accepted Links, or both.

Reviewing & Accepting Suggested Links

When the Suggest Links action is complete, click refresh in the notification 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 must have the View permission on the documents referenced by the Suggested Link to accept or reject it. 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 Scientific Statement 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.

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

In cases where there is an exact text match between text in the document and a statement, Vault creates an Auto Link annotation after performing the Suggest Links action. Auto-Accepted Links are similar to Suggested Links, but Vault adds the resulting annotations without the need for you to review and accept links. You cannot move Auto-Accepted 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 Scientific Statement records for all Auto-Accepted Links in the Scientific Statements section of the document fields panel.

If your Admin has disabled Auto-Accepted Links, Vault generates Suggested Links for all matches.

Manually Linking to Statements

Vault does not generate Suggested Links or Auto-Accepted Links for non-text content. You can manually add links to Scientific Statements in documents if manual linking to statements is enabled in your Vault, the document has a viewable or video rendition, and the Suggest Links action is enabled for the document type. To add links to statements manually:

  1. Click View annotations () to enter annotation mode.
  2. Click Select annotation tool () and select Link ().
  3. Click the Select link type () drop-down and select Scientific Statement. 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. You must have at least one (1) approved Scientific Statement with the same Primary Country and Primary Product as the document to manually link to a statement.
  4. Highlight the area or text to place the link to open the record picker dialog containing all Approved statements you have permission to view. Vault auto filters these statements based on matching fields.
  5. Select the desired statement, 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.

When selecting statements, you can hover over the Scientific Statement name to display its record in a hover card. You can also click to view the Scientific Statement record detail page.

Vault displays the related Scientific Statement records for statements links added manually in the Scientific Statements section on the Doc Info page, and documents containing statement links appear in the Where Used panel of a Scientific Statement record detail page. You must be in a document role with Annotate and Edit Relationships permissions to manually link to Scientific Statements.

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 Statement 001. If Jane performs the Suggest Links user action on Document A, the resulting annotation contains only a link to Statement 001 and does not contain a link to Document A.

Additionally, if a user creates a statement link by selecting a Scientific Statement 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 statement link and selects Statement 001 in the record picker dialog, the resulting annotation contains only a link to Statement 001 and does not contain a link to Document A.

Copying Statements

When creating a new Scientific Statement by copying an existing record, Vault prompts you to select a Reason for Copy. Vault automatically populates the Source Statement field on the new record with the original Statement from which this Statement derives.

To undo the Auto-Linking action and delete all Suggested Link and Auto Linked annotations from a document:

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

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

Removing Manually Accepted Suggestions

To remove manually accepted Suggested Links, you must click the Actions menu on each individual link and select Delete.

From the Filter menu, you can select which kinds of annotations Vault displays:

  • Select Auto-Accepted Links to see only links automatically generated by Vault. This includes Approved Links and Auto-Accepted Links.
  • Select Suggested Links to see only Suggested Links in Pending status.
  • Select Manual Links to show only links created manually. This includes Document Links and statement links.

Viewing the Where Used Component On Scientific Statement Records

The Where Used section of a Scientific Statement’s record detail page lists all document versions where Vault has generated suggested links or Auto-Accepted Links for that Statement, or where users have added links manually. Vault lists each document version once. If multiple versions of the same document have links for a Scientific Statement, Vault lists each version in its own row.

The Where Used component includes the following columns:

  • Name: The name and version of the document where the Scientific Statement is used. Hover over the name for more information or click to navigate to the document version.
  • Number: The document number of the document where the Scientific Statement is used.
  • Status: The lifecycle state of the document where the Scientific Statement is used.
  • Suggested: The total number of Suggested Links, including Pending, Accepted, and Rejected links. This column does not include links deleted with the Remove Suggested Links action.
  • Pending: The total number of Suggested Links in Pending status.
  • Accepted: The total number of Suggested Links in Accepted status.
  • Rejected: The total number of Suggested Links in Rejected status.
  • Manual: The total number of links added manually.
  • Auto: The total number of Auto-Accepted Links.
  • Last Used: The timestamp when a link was most recently created or accepted on the document. This includes Suggested, Auto, and manual links.

By default, Vault sorts documents by the most recently used. You can set a different sort order by clicking the header of any column. Select Edit Columns from the Actions menu to add, remove, or reorder columns.

Limitations

Statement management has the following limitations:

  • Vault cannot create Suggested Links on non-text content.
  • Suggested Links in Pending status cannot find Statements that spans across multiple pages.
  • Suggested Links in Pending status do not appear in PDF With Annotations or Export Annotations downloads.
  • Users cannot download Suggested Links in Pending status with the Download Notes action.
  • Users cannot run the Suggest Links user action or accept pending links on archived documents, but they can remove pending links.
  • Vault does not bring forward Suggested Links in Pending or Approved status or Auto-Accepted Links.
  • When using the Make a Copy action on a document, Vault temporarily shows pending Suggested Links, Approved Links, and Auto-Accepted Links in the unsaved new document. These annotation types are not copied to the new document once it is saved. Manual 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-Accepted Links is enabled for your Vault. Contact Veeva Support to enable this feature.

If an Admin has not configured your Vault to use the Enhanced Suggested Links functionality, suggested links behave differently.

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

  • Your Admin has enabled the _Suggest Link_s action on the document type.
  • 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 Scientific Statement.

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. The Suggest Links action can generate Suggested Links, Auto-Accepted Links, or both.

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 must have the View permission on the documents referenced by the Suggested Link to accept or reject it.

The following permissions control functionality related to Scientific Statement management:

Type Permission Label Controls
Security Profile Objects: Scientific Statement: Create, Edit, Delete Ability to create, edit, and delete statements, including references.
Security Profile Objects: Scientific Statement Target: Create, Edit, Delete Ability to see and add suggested links.
Security Profile Objects: Link Target: Create, Edit, Delete Ability to see and add suggested links and to see and use the Remove Suggested Links action.
Security Profile Objects: Link Target: Object Action Permissions: Preview: View, Execute Ability to see and use the Preview action to view the list of existing targets on a reference. The Business Administrator Actions, System Administrator Actions, and Vault Owner Actions standard permission sets include these permissions, but they must be added to custom permission sets.
Security Profile Objects: Link Target: Object Action Permissions: Remove: View, Execute Ability to see and use the Remove action to remove a reference document from a Statement. The Business Administrator Actions, System Administrator Actions, and Vault Owner Actions standard permission sets include these permissions, but they must be added to custom permission sets.
Document Role Annotate Ability to perform the Suggest Links action.
Document Role Edit Relationships Ability to perform the Suggest Links action.
Lifecycle State View Content Ability to accept or reject a Suggested Link. The user must have the View Document permission to accept a Suggested Link that references a document, and View Content to accept a Link that references an anchor within a document.