Configuring Scientific Statement Management

Vault Medical provides the ability to create and manage reusable scientific statements through the Scientific Statements (annotation_keywords__sys) object.

You can navigate to Business Admin > Objects > Scientific Statements to create and edit statement records.

Enabling & Configuring Statement Linking

Vault Medical allows you to manually or automatically generate reference links on Scientific Statements in content. You can configure statements and associated references, allowing users to create four types of 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.
  • Manual Links: While adding annotations, users 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 Primary Country as the given document to manually link to a statement.

Suggested Links must be enabled on the specific document type where you want it to be available, and link annotations must be enabled in your Vault’s Application Settings.

  1. Navigate to Admin > Settings > Application Settings.
  2. In the Linked Documents section, select the Allow creation of link annotations checkbox.
  3. In the Documents section, select the Enable Enhanced Suggested Links checkbox. Do not select this checkbox if you want to use the platform Suggested Links functionality.
  4. Navigate to Admin > Configuration > Document Types.
  5. From the Actions menu next to the document type or subtype you want to enable, select Edit Details.
  6. Under Enable “Suggested Links” Action, select Enable Action or Do not Enable Action. For document types, you can choose Inherit from Base Document to allow or disallow the Suggested Links action based on the setting of the base document type. Similarly, document subtypes and classifications can inherit enablement from their parent document type. Alternately, you can choose to enable or not enable the action individually for each specific document type, subtype, or classification.

Next, you’ll need to add the Suggest Links user action and entry action to any document lifecycle state.

The following settings are enabled by default in new Vaults:

  • Enable Enhanced Suggested Links: Enables Scientific Statements and Suggested Links.
  • Allow linking via selection of approved Annotation Keywords records: Allows users to manually add Scientific Statement links by selecting Approved records when adding link annotations.
  • Exclude specific characters when matching Annotation Keywords to content: Allows Vault to ignore specific characters when evaluating a given string against a Scientific Statement’s Statement or Statement Variation. By default, Vault ignores copyright (©), registered (®), trademark (™), and servicemark (℠) characters. You can add or remove characters from this list, or disable this checkbox to include these characters in match criteria.
  • Exclude superscript and subscript characters when matching Annotation Keywords to content: Allows Vault to ignore superscript and subscript characters when matching text. You can disable this checkbox to include these characters in match criteria.

To allow Auto-Accepted Links if there is an identical match:

  1. Navigate to Admin > Settings > General Settings.
  2. Click Edit.
  3. In the Documents section, select the For Suggested Links, bypass Approve step on exact matches checkbox.
  4. Click Save.

Updating the Scientific Statement Page Layout

To select a Primary Country and Primary Product when creating Scientific Statements, you must modify the Scientific Statement object page layout:

  1. Navigate to Configuration > Objects > Scientific Statement.
  2. Click the Page Layout tab.
  3. Click Claim Detail Page Layout.
  4. Under Details, click Add and select Primary Country.
  5. Click Add again and select Primary Product.
  6. Click Save.

Adding a Scientific Statements Tab

To allow users to access Scientific Statements, you can add a custom tab:

  1. Navigate to Admin > Configuration > Tabs.
  2. Click Create.
  3. Enter Scientific Statements as the Label.
  4. Click the Tab Type drop-down and select Object.
  5. Click the Object drop-down and select Scientific Statements.
  6. Under Creation Options, select Create record in pop-up dialog.
  7. Click Save.

Managing the Statement Library

Before users can generate links, you’ll need to complete the following steps, which are detailed below:

  • Confirm that the appropriate reference documents exist in your Vault. Upload additional documents if necessary and classify them with a document type that is enabled as a target for Suggested Links.
  • Create anchors on reference documents using the Create Anchors tool.
  • Create Scientific Statements records.
  • Review and approve statements via the Scientific Statement lifecycle. Vault only uses statements in the Approved state to suggest links.

Vault limits Statement values, including statement variations, to 500 within all active records with identical matching field values. For example, a statement with three (3) statement variations would count as four (4) Statement values towards the limit of 500.

Creating New Scientific Statement Records

Scientific Statements are managed as object records within Vault.

To create a new statement:

  1. From the Scientific Statements tab, click Create.
  2. Enter the Statement. This is the wording that will be used to suggest links to reference documents. By default, the statement must be between five (5) and 1500 characters.
  3. Optional: Enter a Category.
  4. Optional: Select a Primary Country.
  5. Optional: Select a Primary Product.
  6. Optional: Select a Language.
  7. Click Save, or to enter another statement, click Save + Create.

You can edit or add additional information to a statement by clicking Edit on the Scientific Statement Info page.

Managing Languages

To add a language:

  1. Navigate to Admin > Settings > Language & Region Settings and click Edit.
  2. Select the Enable multilingual document handling checkbox and click Save.
  3. Navigate to Business Admin > Objects > Languages and click Create.
  4. Enter the language Name.
  5. Select a corresponding Language.
  6. Optional: Enter a Language Code.
  7. Click Save.

After creating a Language value, navigate to Business Admin > Objects > Country Language and click Create. Select a Country and a Language to create a join, indicating that the Language selected is approved for use in the specified Country. This populates the Language field available during Scientific Statement creation.

Relating Scientific Statement Records to Products & Countries

Using the join objects Scientific Statement Country and Scientific Statement Product, you can relate Scientific Statements to multiple products and countries.

You can also navigate to Admin > Settings > Application Settings and, under Join Object Records, select the Enable Scientific Statement Country Join Object Record Creation SDK and Enable Scientific Statement Product Join Object Record Creation SDK checkboxes to enable automatic join record creation.

Users can search for Scientific Statement Country and Scientific Statement Product object records.

You can use the Get Link Annotation Data bulk document action and Vault Loader to create Scientific Statement, Link Target, and Scientific Statement Target records in bulk from existing link annotations on a defined set of documents. To extract annotation data from documents via a bulk action, see Using Bulk Document Actions.

After completing the bulk document action, download and unzip the link annotation data file. The package contains three files, which must be loaded in numerical order and are named as follows:

  • 1_annotation_keywords__sys.csv: This file contains data that Vault uses to create new Scientific Statement object records.
  • 2_link_target__sys.csv: This file contains data that Vault uses to create new Link Target object records.
  • 3_annotation_keyword_targets__sys.csv: This file contains data that Vault uses to create new Scientific Statement Targets object records.

Creating Scientific Statements Records

Before you begin, you may wish to edit 1_annotation_keywords__sys.csv in one or more of the following ways:

  • Add columns and values for any required Scientific Statement fields not already present in the CSV. This is only necessary if you have added required fields to the Scientific Statement object.
  • Edit other specific values as needed. For example, you may wish to revise values in the match_text__sys column for brevity.
  • When you extract link data from a Steady state document, the corresponding state__v column defaults to approved_state__sys. If you do not wish to create statements in the Approved state from approved documents, you must edit this column value before uploading.

To create new Scientific Statement records:

  1. From the Loader tab, click the Choose button in the CSV File fields and select the 1_annotation_keywords__sys.csv file.
  2. From the Object Type dropdown, select Scientific Statements (annotation_keywords__sys).
  3. From the Action Type dropdown, select Create.
  4. Select the Record Migration Mode checkbox.
  5. Click the Start Load button.

When creating Scientific Statement records in the Approved state:

  • The Approved state must be defined in the CSV.
  • The Scientific Statement must pass validation for the Approved state.

If these conditions are not met, Vault creates the records in Draft state.

When creating Scientific Statement records in the Approved state, loading 1_annotation_keywords__sys.csv without loading one or both of the additional files results in Approved statements without references. Vault ignores these records when performing the Suggest Links action.

Link Target records establish the relationships to documents and anchors. To create new Link Target records:

  1. From the Loader tab, click the Choose button in the CSV File fields and select the 2_link_target__sys.csv file.
  2. From the Object Type dropdown, select Link Targets (link_target__sys).
  3. From the Action Type dropdown, select Create.
  4. Click the Start Load button.

Creating Scientific Statement Target Records

Scientific Statement Target records join Scientific Statement records to Link Target records. To create new Scientific Statement Targets records:

  1. From the Loader tab, click the Choose button in the CSV File fields and select the 3_annotation_keyword_targets__sys.csv file.
  2. From the Object Type dropdown, select Scientific Statement Targets (annotation_keyword_targets__sys).
  3. From the Action Type dropdown, select Create.
  4. Click the Start Load button.

When bulk creating records with Vault Loader, note the following:

  • The bulk action only exports data from manually created link annotations with text selection. Vault does not export data from manual links with image selection, nor from Suggested, Approved, or Auto-Accepted Links.
  • The resulting Scientific Statement’s Statement is defined by the selected text from the link annotation. You can edit these values before uploading.
  • Matching field values in a Scientific Statement record are defined by values in the same fields on the source document.
  • You must load all three files in numerical order in order to create Scientific Statements with references.
  • The user performing the Loader action becomes the Scientific Statement creator.

Configuring the Statement Selector

When manually linking to statements, you can configure which field values display in the Select anchors dialog. Navigate to Admin > Configuration > Object > Scientific Statement > Fields. Click the field, then select the Display in default lists and hovercards checkbox to display the field and its values in the dialog.

Adding Scientific Statement Variations

Sometimes, the same statement can be worded in multiple ways. You can configure each Scientific Statement record to match with variations on the statement by using Statement Variations.

Statement Variations allow you to add up to five (5) alternate phrases to each Scientific Statement record. For example, a Scientific Statement might have the statement “Up to 70% of cancer patients may suffer from nausea or emesis following chemotherapy.” Adding “Following chemotherapy, up to 70% of cancer patients may suffer from nausea or emesis” as a Statement Variation allows you to track both variations in the same Scientific Statement record.

Statement Variations have their own lifecycle, and must be in the Approved state in order to be used by Suggest Links.

When adding or updating Statement Variations, Vault does not evaluate excluded characters in statements. For example, Vault prevents adding the Statement Variation “The Natevba© regimen is safe and effective” to a Scientific Statement with a statement or statement variation value of “The Natevba regimen is safe and effective” because they are considered duplicates.

Contact Veeva Support if you need to add more than five (5) Statement Variations to a Scientific Statement record.

To add a Statement Variation:

  1. From the Scientific Statement record detail page, open the Statement Variations panel and click the Create button.
  2. Enter the alternate Statement.
  3. Click Save, or click Save + Create to enter additional variations.

Adding, Previewing, & Removing References

References provide proof of the validity of a statement. They can be anchors or entire documents. You can add multiple references to each statement.

You can add a reference from the Scientific Statement record detail page. Click the Add button under References to open the Select Anchors dialog. This window displays a list of all the documents in your library that you have View Document permissions for and have a document type configured to enable referencing from suggested links. If you have View Content permissions on the document, you will also see all anchors on those documents.

You can choose from the list, use the search bar to find documents, or add filters. You can also hover over the name of the document or anchor for more information, click the name to open the document or anchor, or click the Preview Link icon next to an anchor to view the target in a mini-browser window. To preview a document in a mini-browser, click the View and select anchor in this document link below the document name. If you have the Create Anchors permission, this link will read Select or create anchor in this document and you can create new anchors within the mini-browser. Click on the plus (+) icon next to each document or anchor you want to add in the Select Anchors dialog, then click Close to add the references.

From the Actions menu next to each reference’s name, you can select Preview to see a list of existing targets on a record, or select Remove to remove the reference and its related Scientific Statement Target and Link Target records.

You must have View and Execute permissions on the Preview and Remove object action permissions for the Link Target object to use these actions. The Business Administrator Actions, System Administrator Actions, and Vault Owner Actions standard permission sets include these permissions, but they must be added to other standard permission sets and any custom permission sets.

While creating statements, you can add references to permalink targets. Permalink targets are versionless and always link to the latest available version of the referenced document. You can create links to permalink targets such as documents, pages, bookmarks, and named destinations. To add references to permalink targets, create a reference using the Permalink target type. As a result, users can create Suggested Links and Auto-Accepted Links to Permalink targets.

Suggested and Auto-Accepted Links to permalink targets are only available when the following feature flags are enabled:

To prevent suggesting invalid links, Vault removes associated references from any Scientific Statement records that reference them and, if the record is in Approved state, returns it to Draft state when:

  • A user deletes a targeted document or anchor.
  • A target document enters a lifecycle’s Obsolete state.
  • A target document’s document type configuration is changed to be ineligible as a target for Suggested Links.
  • A target document’s document type is changed to a different document type that is ineligible as a target for Suggested Links.

Vault prevents you from creating whole-document links to the current 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. See About Self-Referencing Links for more information.

If you are not using the Enhanced Suggest Links feature, you must enable statement linking on the specific document types, subtypes, or classifications where you want it to be available.

Enabling & Disabling Document Types as Targets for Suggested Links

When you enable a document type as a target for platform Suggested Links, all documents of that type become eligible for selection in the Select Anchors dialog when a user adds references to a Scientific Statement.

When you disable a document type, all documents of that type become ineligible for selection in the Select Anchors dialog, and all anchors or documents of that type are removed from any Scientific Statement records in which they appear. If you later re-enable the document type as a target, Vault restores the previously removed references.

To configure platform Suggested Links targeting for a document type:

  1. Navigate to Admin > Configuration > Document Types.
  2. From the Actions menu next to the document type or subtype you want to enable, select Edit Details.
  3. Under Enable “Suggested Links” Target, select Enable as Target or Do not Enable as Target. For document types, you can choose Inherit from Base Document to allow or disallow the Suggested Links targeting based on the setting of the base document type. Similarly, document subtypes and classifications can inherit enablement from their parent document type. Alternately, you can choose to enable or not enable targeting individually for each specific document subtype.

Using Wildcards

Statements may include variable content such as adjectives, footnote references, and trademark symbols. Using wildcards in statements allows Vault to match content in a document to a Scientific Statement record, even when variable words and characters exist. You can use wildcards in both primary statements and in Statement Variations.

Wildcards are formatted as {*}.

There are two types of wildcards. Standalone wildcards have a space on each side and can represent up to ten whole words. For example, “Cholecap is {*} good” would match “Cholecap is good,” “Cholecap is very good,” and “Cholecap is the gold standard of good.” Vault ignores standalone wildcards at the beginning and end of statements.

Attached wildcards are used at the beginning, middle, or end of a word and add an unlimited number of characters to that word only. For example, “Chole{*} works well” matches “Chole works well”, “Cholecap works well”, and “Cholecap1 works well”.

Each statement entry can include up to three (3) wildcards. When two or more wildcards of the same type appear consecutively, Vault only uses the first wildcard and ignores any subsequent consecutive wildcards. For example, either “when taking Cholecap {*} for the first time” or “when taking Cholecap {*} {*} for the first time” matches “when taking Cholecap for the first time” and “when taking Cholecap OTC XR for the first time.” When two wildcards of different types appear consecutively, Vault uses both wildcards.

Vault counts wildcards as plain text characters when validating minimum and maximum statement length.

About Excluded Characters

Statements often contain certain characters, such as copyright and trademark symbols, whose presence or absence does not affect the meaning of the statement. Vault ignores these characters when evaluating whether a given text string is identical to a Scientific Statement record’s statement or Statement Variation.

For example, if copyright symbol © is included in Excluded Characters, a Statement value of “Cholecap works best with a Heart Healthy diet” matches both “Cholecap works best with a Heart Healthy diet” and “Cholecap© works best with a Heart Healthy diet”.

By default, the set of Excluded Characters is:

  • Copyright: ©
  • Registered: ®
  • Trademark: ™
  • Servicemark: ℠

Editing & Disabling Excluded Characters

To edit the list of excluded characters, navigate to Admin > Settings > General Settings and click the Edit button. Then, in the Documents panel, add or remove characters in the Excluded Characters field. Vault limits this field to 20 characters, including spaces.

There is a known issue which causes Vault to ignore wildcards in statements and Statement Variations when {curly brackets}, asterisks(*), or both are included in excluded characters.

Vault treats each character independently. For example, if you add the word “always” to the set, Vault will treat each letter (“a” and “l” and “w” etc.) as a separate excluded character.

To disable excluded characters, clear the Exclude specific characters when matching Annotation Keywords to content checkbox.

Excluding Subscript and Superscript Characters

By default, Vault excludes subscript and superscript characters at the end of words when matching Scientific Statements to text. To include these characters, clear the Exclude superscript and subscript characters when matching Annotation Keywords to content checkbox.

Preventing Duplicate Scientific Statement Records

When you click Save on a Scientific Statement record, Vault prevents you from creating or updating the record if the statement value and all other matching field values are identical to another existing Scientific Statement record.

As with duplicate prevention for Statement Variations within a Scientific Statement, duplicate prevention for Scientific Statement records treats wildcards in statements as plain text. Therefore, “Trust Chole”, “Trust Chole{*}”, and “Trust Cholecap” are not duplicate values. However, Vault ignores excluded characters, trailing periods, and exclamation points in duplicate validation, meaning that “Trust Cholecap®”, “Trust Cholecap.”, and “Trust Cholecap!!!” are considered duplicate values.

Vault does not evaluate inactive Scientific Statement records for duplicate prevention; however, it does prevent you from making a Scientific Statement record active if it is a duplicate of another active Scientific Statement.

Disabling Manual Linking to Scientific Statements

By default, Vault allows users to add statement links to documents manually by selecting approved Scientific Statement records when adding annotations. To disable this feature, navigate to Admin > Settings > General Settings and, in the Documents section, clear the Allow linking via selection of approved Annotation Keywords records checkbox.

To disable Auto-Accepted Links, navigate to Admin > Settings > General Settings and, in the Documents section, clear the For Suggested Links, bypass Approve step on exact matches checkbox.

About the Scientific Statement Lifecycle

By default, the Scientific Statement lifecycle (annotation_keywords_lifecycle__sys) is an object lifecycle which applies to all Scientific Statement objects. Newly created statements begin in the Draft state and cannot enter the Approved state unless a user adds at least one (1) valid reference. Only statements in the Approved state are available for use in suggesting links.

You can add custom lifecycle states and workflows to suit your organization’s needs. You can also edit the lifecycle name as desired.

While configuring the Scientific Statement lifecycle, you can enable and add entry criteria to one or more states to verify that a Scientific Statement Target join record exists between the Scientific Statement record and a Link Target record.

To add this entry criteria to the Scientific Statement lifecycle:

  1. Navigate to Admin > Settings > Application Settings and click Edit.
  2. Select the Enable Scientific Statement Relationship Entry Criteria checkbox.
  3. Click Save.
  4. Navigate to Configuration > Object Lifecycles > Scientific Statement Lifecycle.
  5. Click a State. We recommend adding this entry criteria to the In Review state.
  6. In the Entry Criteria section, select Edit.
  7. Click Create Rule and add entry criteria as desired, selecting Scientific Statement Target Relationship Exists.
  8. Click Save.

You must have Create, Edit, and Delete permissions on the Scientific Statement, Scientific Statement Target, and Link Target objects in addition to Admin: Configuration: Objects: Create and Edit permissions to create and configure objects.

You must have Create, Edit, and Delete permissions on the Scientific Statement, Scientific Statement Target, and Link Target objects to use Statement Management.

You must have the Bulk Update document permission to perform the Get Link Annotation Data bulk action.