Configuring Submissions Publishing (RIM)

The Submission Publishing application enables users to publish documents from within the Submissions Archive Viewer and the Content Plan Hierarchy Viewer, allowing Vault to progress those published documents through various lifecycle states for review and approval. You can accomplish this by configuring user actions that apply to the Content Plan and Content Plan Item object lifecycles, and the Submissions Archive document lifecycle.

Associated Configuration Options

Submissions Publishing Vaults are provisioned with various configuration options to support the publishing process:

Submission Archive Lifecycle States

The Submissions Archive document lifecycle includes the following states:

• Published: Entry state for published documents that have not been reviewed.
• In Publishing Review: For published documents currently under review.
• Ready to be Submitted to HA: For published documents that have undergone review and are ready to submit to the Health Authority.
• Rejected: The state of published documents that were rejected upon review and require corrections before they can be considered submission ready.

Submissions Archive Lifecycle User Actions

The Submissions Archive document lifecycle includes the following user actions to support the publishing process:

• Open Content Plan: Opens the associated Content Plan for the published document.
• Open Content Plan Item: Opens the associated Content Plan Item record for the published document.
• Open Source Document: Opens the source document used to create the published document.

These actions are not available for the Final state.

Content Plan & Content Plan Item User Actions

The Content Plan and Content Plan Item object lifecycles include the following user actions to support the review and approve content flow:

• Open in Submissions Archive: Opens Submissions Archive Viewer to the corresponding submission, expanded to the corresponding section.
• Open Published Document*: Opens the published document in the document viewer with navigable cross-document links. You can configure this action to only display when the Published Document field is populated on the Content Plan Item.
• Run On-Demand Validation: Refreshes validation results based on recent changes.
• Open Matched Document: Opens the matched document in the document viewer.
• Run On-Demand Publishing and Validation: Publishes the selected item and its descendants, and refreshes validation results. Any affected XMLs are also published and validated.
• Generate Publishing Table of Contents*: Generates or recreates a Table of Contents (TOC) document from the template referenced on the related Publishing Element record and matches it to the Content Plan Item.
• Edit Table of Contents*: Allows users to update a generated TOC, including renaming, promoting/demoting, and activating/inactivating TOC structure components.
• Set Reference Leaf*: Allows users to set a Submissions Archive document as a reference leaf. We recommend configuring the action in the Baselined state.

*Action is available in the Content Plan Item lifecycle only.

Link Annotations

Link annotations and document links allow users to link to specific pages or paragraphs within other documents, the current document, or to complete documents. When users create cross-document links, Vault gathers those links and converts them to standard PDF links with a relative path to the target at the time of publishing. This allows users to easily navigate to referenced pages within a target document.

Configuration Overview

Configuring the Submissions Publishing application involves several steps. To allow users to fully utilize the features to support the publishing process, we recommend working with Veeva Support to configure publishing.

1. Set up the Open Content Plan, Open Source Document, and Open Validation Results document lifecycle user actions. This allows users to view content plans, source documents, and validation results directly from published documents.
2. Set up user actions on the Content Plan and Content Plan Item object lifecycles to support the publishing process.
3. Set up the Publishing Complete entry criteria on the Submission object lifecycle. This prevents Submission records from entering states when pending publishing jobs exist.
4. Configure Content Plan Templates based on the eCTD or non-eCTD structure.
5. Configure content plan constraints.
6. Recommended: Configure the Content Plan Item lifecycle to allow users to set a Submissions Archive document as a reference leaf.
7. Update object page layouts to support the publishing and validation process. See below for detailed instructions.
8. Create Publishing Element records and TOC template documents to allow Vault to automatically generate and publish TOCs. See below for detailed instructions.
9. Enable link annotations and linked documents. You can also enable dynamic linking, if desired. To enable cross-application links, set the Allow Cross Application Linking field to Yes on the Country record selected as the application’s lead market. When enabled, Vault can create links to documents in a different application as long as the applications have the same Lead Market, Health Authority, and Health Authority Division.
10. Enable Vault to automatically calculate and assign a Sequence ID (xml_submission_id__v) when users create a new Submission record.
11. Enable attachments on the Submission object. This allows the Validation Results Archival job to add the archive package ZIP file as an attachment on the Submission record 365 days after the submission is complete.
12. Configure a shared field or matching document fields with the same field type and Name on the Submissions Archive document type and any document types for source documents. Matching fields allow Vault to automatically populate fields on the published document with field values from the source document. If needed, set up Dynamic Access Control rules that match the rules for source documents to ensure that only the appropriate users can see the published documents.
13. Optional: From Admin > Operations > Job Definitions, update the Job Owner for the Validation Results Archival job to the user or group who should receive notifications if the job encounters a failure. By default, the job owner is System, meaning that no user will receive an email if the job fails. If your Vault uses report level content plans, the job owner you set will also receive notifications when Vault archives those validation results. You cannot set the job to inactive.

Table of Contents Configuration

Vault can automatically generate and publish TOC documents. To configure this, first create documents to use as TOC templates and upload them to the Vault Library. See details about configuring a Table of Contents.

Configuration Overview

1. Configure a Controlled Document Template so that TOC template documents can be stored in the Vault Library, then create a new TOC template document which will become the basis of TOCs users will generate. See Creating a Table of Contents Document, below.
2. Configure the Generate Publishing Table of Contents user action on the Content Plan Item object lifecycle. We recommend configuring this action on the Baselined state.
3. Configure the Edit Table of Contents user action on the Content Plan Item object lifecycle to allow users to modify published TOCs. During lifecycle configuration, ensure all applicable lifecycle user roles have Read and Edit permissions for each state in which the action is configured. Users editing TOCs must also have lifecycle state atomic security permissions to Execute the action.
4. Create a Publishing Element record referencing the TOC template document.
5. Create or update Content Plan Item Template records to specify a created TOC’s location in the Vault Library.

Creating a Table of Contents Document

To configure a Table of Contents document for a Content Plan:

1. Configure a Controlled Document Template so that TOC template documents can be stored in the Vault Library. See Configuring Controlled Document Templates for detailed instructions. Depending on your Vault’s configuration, this step may include creating a new document type. We recommend using a document type specific to TOC templates, with minimal required fields and dependencies. For example, a TOC document type with Clinical Study Report and Nonclinical Study Report subtypes can be helpful when uploading different TOC document templates, depending on the Content Plan Template you’re using.
2. Create a TOC template document in Microsoft Word️ and add supported TOC tokens.
3. Upload your Microsoft Word️ .DOCX TOC template document to your Vault. Classify the document according to the Controlled Document Template configuration followed in Step 1.

Creating Publishing Element Records

To create Publishing Element records:

1. Navigate to Admin > Business Admin > Publishing Element and click Create.
2. Enter a Name.
3. In the Applicable Node Type field, choose Table of Contents.
4. In the TOC Template field, select the appropriate template document from the Vault Library as created above.
5. Set the Page Numbering for the TOC document to Document Level Page Number.
6. Click Save.

Configuring the Content Plan Item Template

To configure the Content Plan Item Template:

1. Navigate to or create a new Content Plan Item Template record.
2. In the Full Document Type field, select the desired document type, subtype, and classification for the created TOC document, for example, Clinical Study > Table of Contents. Vault uses this selection to classify the created document.
3. In the Node Type (xml_node_type__v) field, select Table of Contents from the drop-down. This indicates that Vault should create the document as a Table of Contents. If you don’t select this node type, the user actions will not be available.
4. In the Source for Published Document field, to support custom Rendition Types, add the values to the Source for Published Document picklist. Ensure that the text string of the Picklist Value Name exactly matches the Rendition Type Name.

Reference Leaf Configuration

To allow users to set a Submissions Archive document as a reference leaf:

1. Activate the Set Reference Leaf system action on the Content Plan Item object.
2. Ensure the users in your Vault have the appropriate permissions to set reference leafs.

Related Permissions

To set a reference leaf, a user must be assigned a Full User license for the RIM Submissions Publishing and RIM Submissions Archive applications.

Additionally, within the Content Plan Item object lifecycle, you must ensure users have the ability to execute the action and edit certain Content Plan Item fields through Atomic Security. We recommend using the Baselined lifecycle state for the following Atomic Security parameters:

• Any role to which users are assigned (for example, Document Contributor) must have Edit permission in all applicable lifecycle states.
• Any role to which users are assigned must have Atomic Security Edit permission for the following fields: Node Type, Published Output Location, XML Operation, and XML Modified File. This permission must be configured for applicable object types, or you can apply them to All Object Types. Confirm or select this information in the dropdown below the Atomic Security: Fields heading.

Finally, users must be assigned to a permission set with the following minimum requirements to set a reference leaf:

Type	Permission Label	Controls
Permission Set	Object: Content Plan Item: Read	Ability to view records in the Content Plan Item object.
Permission Set	Object: Content Plan Item object types: Read	Ability to view records in the applicable Content Plan Item object types.
Permission Set	Object: Submission: Read	Ability to view records in the Submission object.
Permission Set	Object: Submission object types: Read	Ability to view records in the applicable Submission object types.

Overlay Configuration

Vault allows you to configure an overlay to apply during publishing. You can assign an overlay to a content plan item or create a default overlay on the submission. During publishing, Vault applies the overlay defined in the content plan item’s Publishing Element record. If no Publishing Element exists on the content plan item, Vault applies the default overlay. If the Publishing Element exists but does not define an overlay, Vault does not apply an overlay.

To configure an overlay on a content plan item, first create one or more overlay templates.

Next, create a Publishing Element record for the overlay:

1. Navigate to Admin > Business Admin > Publishing Element and click Create.
2. Enter a Name.
3. In the Applicable Node Type field, choose Leaf.
4. In the Overlay field, select the desired overlay template.
5. Click Save.

To set the default overlay on a submission, you must use the Set Default Overlay user action on the Submission record. You cannot configure the Default Overlay field directly.

Updating Object Page Layouts

Make the following updates to various object page layouts to support the publishing process:

• Add the Open Validation Results field to the Content Plan Item object page layout.
  • Content Plan Item
  • Content Plan Item Template
• Add the Publishing Status field to the page layouts for all object types of the objects below. This ensures that users can see the publishing and validation progress for the whole content plan as well as for each component.
  • Submission
  • Content Plan
  • Content Plan Item
• Add a related object section for the Submission Validation Result object to page layouts for all object types of the following objects:
  • Submission
  • Report Level Content Plan
  • Content Plan
  • Content Plan Item.
• Edit the object page layout for the Submission Validation Result object and select Create Section > Detailed Publishing Results. This section allows users to see additional details about validation failures.

Enabling Link Annotations & Linked Documents

Link annotations and document links are available in RIM Publishing Vaults. To enable annotations, navigate to Admin > Settings > General Settings and select the Links and Restore Placemarks on Brought Forward Annotations checkboxes beneath Allow users to bring forward annotations.

To enable linked documents, navigate to Admin > Settings > Application Settings and select the following checkboxes:

• Allow creation of link annotations
• Enable Create & Import Document Links
• Allow creation of links to whole documents
• Bring forward Linked Document relationships to new versions

Enabling Dynamic Linking

To enable Dynamic Linking, navigate to Admin > Settings > Application Settings and set the Enable RIM Dynamic Linking checkbox. When enabled, Vault updates Microsoft Word️ DOCX documents in the Library to include PDF named destinations for each heading, table, figure, and title style in the document. These persist within the viewable rendition’s bookmark targets.

Creating Keyword Links

You can define Keywords and additional match text variations that target a defined link destination. While you can define more than one target, Submissions Publishing only resolves the first target created. Users can then create four types of link annotations:

• Suggested Links: When a user clicks the Suggest Link button on a document, Vault generates Suggested Links for non-exact text matches, which the user must review and accept or reject.
• Approved Links: When a user accepts a Suggested Link, it becomes an Approved Link.
• Auto Links: When users click the Suggest Link button on a document, Vault generates Auto Links for exact text matches, which do not require review or approval.
• Keyword Links: Users can select the Keyword type to manually select a Keyword based on matching fields.

Keywords are managed as object records within Vault.

To define Keywords:

1. Navigate to Business Admin > Keywords and click Create.
2. Enter the Match Text. This is the wording that will be used to suggest links. By default, the match text must be at least ten (10) characters.
3. Optional: Select a Category for the Keyword.
4. Click Save, or to enter another Keyword, click Save + Create.

Enabling & Disabling the Suggested Link Action

Keyword linking must be enabled on the specific document types, subtypes, or classifications where you want it to be available, and link annotations must be enabled in your Vault’s Application Settings. To configure the Suggest Links action:

1. Navigate to Admin > Settings > Application Settings.
2. In the Linked Documents section, set the Allow creation of link annotations checkbox.
3. Navigate to Admin > Configuration > Document Types.
4. From the Actions menu next to the document type or subtype you want to enable, select Edit Details.
5. 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.
6. Click Save.

Enabling & Disabling Document Types as Targets for Suggested Links

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

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 Keyword records in which they appear. If you later re-enable the document type as a target, Vault restores the removed references.

To configure 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.

Disabling Manual Linking to Keywords

By default, Vault allows users to add Keyword links to documents manually by selecting approved Keyword 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.

Disabling Auto Links

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

Adding Match Text Variations

Sometimes, the same Keyword can be worded in multiple ways. You can configure each Keyword record to match with variations on the match text by using Match Text Variations and wildcards.

Match Text Variations allow you to add up to five (5) alternate phrases to each Keyword record. For example, a Keyword might have the match text “Cholecap can significantly reduce LDL-C when used as directed.” Adding “When used as directed, Cholecap can significantly reduce LDL-C” as a Match Text Variation allows you to track both variations in the same Keyword record.

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

Contact Veeva Support if you need to add more than five Match Text Variations to a Keyword record.

To add a Match Text Variation:

1. From the Keyword record detail page, open the Match Text Variations panel and click the Create button.
2. Enter a Name for the match text variation.
3. Enter the alternate Match Text.
4. Click Save, or click Save + Create to enter additional match text variations.

Using Wildcards

Keywords often include variable content such as adjectives, footnote references, and trademark symbols. Using wildcards in match text allows Vault to match content in a document to a Keyword record, even when variable words and characters exist. You can use wildcards in both primary match text and in Match Text 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 (10) 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 match text.

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 match text 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 match text length.

About Excluded Characters

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

For example, if copyright symbol © is included in Excluded Characters, a Match Text 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 Match Text and Match Text Variations when {curly brackets}, asterisks(*), or both are included in excluded characters.

Note that 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.

Adding, Previewing, & Removing References

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

You can add a reference from the Keyword record detail page. Click the Add button under References and select Document or Permalink targets. Document targets include links to anchors in documents. Permalink targets include links to documents, pages, bookmarks, and named destinations. Permalink targets are versionless and always link to the latest available version of the referenced document.

To add a reference to an anchor, select the Document target type to open the Select anchors dialog. To add a Permalink reference, select the Permalink target type to open the Select targets dialog. Vault displays a list of all the documents in your library that you have View Document and/or View Content permissions for and have a document type configured to enable referencing from suggested links.

You can choose from the list, use the search bar to find targets, or add filters. You can also hover over the name of the document or anchor for more information and click the name to open the document or anchor.

In the Select anchors and Select targets dialogs, you can click the View and select link below the target name. If you have the Create Anchors permission, this link will read Select or create and you can create new anchors or permalinks within the mini-browser. Click on the plus (+) icon next to each document or anchor you want to add, then click Close to add the references. In the Select anchors dialog, you can also click the Preview Link icon next to an anchor to view the target in a mini-browser window.

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 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.

Preventing Duplicate Keyword Records

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

As with duplicate prevention for Match Text Variations within a Keyword, duplicate prevention for Keyword records treats wildcards in match text 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 Keyword records for duplicate prevention; however, it does prevent you from making a Keyword record active if it is a duplicate of an active Keyword.

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.

About the Keywords Lifecycle

The Keywords lifecycle is an object lifecycle which applies to all Keyword objects. Newly created Keywords begin in the Draft state and cannot enter the Approved state unless a user adds at least one (1) valid reference. Only Keywords 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.

Preventing Invalid Suggested Links

To prevent RIM from suggesting invalid links, Vault removes associated references from any Keyword 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.

Related Permissions

You must have Create, Edit, and Delete permissions on the Keyword, Keyword Targets, and Link Target object 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 Keyword, Keyword Targets, and Link Target objects to use Keyword Linking.

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