Enable Rules Based Narrative Generation

With the 25R1 release, you can configure rules for narrative generation based on case-related data. Create Narrative Outline templates composed of Narrative Statements, each with their own Narrative Statement Options, where you can define the conditional rules for when Vault includes the related statement within a generated narrative. Narrative Statement Options incorporate case-related data and new functions for formatting statements. You can specify the order of statements according to their alignment and sequence. For easy reference, any changes to between major versions are summarized at the end of a generated narrative.

After you have enabled this feature, see the following articles for more information:

• Configure Rules Based Narratives
• Generate a Case Narrative

Updates

We have made the following updates to this feature:

• Japan Rules-Based Narratives: With the 26R2 release, Veeva Safety supports rules based narratives for Localized Cases and generates narrative documents in Japanese for submissions to the PMDA. To configure your Vault for the updated feature, ensure the Localized field is active on the Narrative Outline object layout and configure the Generate Local Narrative from Outline action on the Localized Case object.
• Manage Blind Protection for Case Narratives: With the 25R3 release, you can turn off blind protection for generated narratives.
• Rules Based Narratives Enhancements: With the 25R2 release, you can copy standard outlines and their related statements and options using the Copy Narrative Outline action.
• Previous Case Version Narrative on Follow-Up: With the 25R2 release, you can define settings to specify which narrative documents Vault generates for follow-up Cases.

Prerequisite

If you’re interested in discussing whether getting early access to this feature is appropriate for your business needs, contact your Veeva Representative.

Overview

Complete the following procedures to enable Rules Based Narrative Generation in your Vault:

1. Configure object layouts
2. Configure generate narrative actions
3. Configure Narrative Outline actions
4. Update the Case Compare Page
5. Define settings for narrative generation
6. Optional: Update the Case Test Result layout
7. Optional: Configure Case Access Group Security

Configure Object Layouts

We recommend copying the standard layouts for all objects that support rules based narratives, activating them, and setting them as the defaults.

Configure Generate Narrative Actions

You can configure the following actions for users to generate narratives:

• Generate Narrative from Outline
• Generate Local Narrative from Outline

Generate Narrative from Outline

You can configure the Generate Narrative from Outline action in the following ways:

• Assign the action to the Case object and complete the following according to your business needs:
  • Add the action as a user action to the object and do one of the following:
    • Select the Available in All Lifecycle States checkbox to apply atomic action security defaults for the applicable lifecycle states.
    • Add the action as a user action to the applicable states of the object lifecycle.
  • Add the action as an entry action on the applicable object lifecycle states.
• Configure the action as a workflow action step.

If you previously configured Narrative Templates for Report Types and Studies in your Vault, we recommend inactivating the Re-Render Case Narrative action on the Case object since users can instead rerun the Generate Narrative from Outline action.

Generate Local Narrative from Outline

You can configure the Generate Local Narrative from Outline action in the following ways:

• Assign the action to the Localized Case object and complete the following according to your business needs:
  • Add the action as a user action to the object and do one of the following:
    • Select the Available in All Lifecycle States checkbox to apply atomic action security defaults for the applicable lifecycle states.
    • Add the action as a user action to the applicable states of the object lifecycle.
  • Add the action as an entry action on the applicable object lifecycle states.
• Configure the action as a workflow action step.

Configure Narrative Outline Actions

We recommend configuring the following actions on the Narrative Outline object:

• Preview Narrative Outline: Define the web action as a user action on the Active state of the object’s lifecycle.
• Copy Narrative Outline: Assign the action to the Narrative Outline object and then define the user action on the applicable states of the object’s lifecycle to copy outlines with their related Narrative Statements and Narrative Statement Options.

Update the Case Compare Page

We recommend adding the following fields to the Case Compare Followup layout for the Case Version Compare page so that users can review summary statements on the Inbox Item to Case Compare page:

• Patient section:
  • Date of Birth (normalized)
• Adverse Events section:
  • Seriousness
  • Onset (normalized)
  • Cessation (normalized)
• Medical History & Concurrent Conditions section:
  • Start Date Normalized
  • End Date Normalized
• Drug History section:
  • Start Date Normalized
  • End Date Normalized
• Products section > Dosage Fields:
  • First Administration (normalized)
  • Last Administration (normalized)

Define Settings for Narrative Generation

You can define settings to control how Vault generates follow-up narratives and to turn off blind protection on narratives. To define settings in your Vault:

1. Navigate to Admin > Settings > Safety General Settings.
2. Select Edit.
3. In the Other Options section, select the applicable checkbox:
   • Default to previous case version narrative on follow-up
   • Turn off Blind Protection on Narratives
4. Select Save.

Follow-Up Narratives

You can control which minor narrative document versions Vault generates for non-E2B sources when users create a follow-up Case or Localized Case with the Default to previous case version narrative on follow-up setting. When enabled, Vault generates a single narrative document by copying the previous narrative version and does not generate a new narrative from the outline template.

If you do not enable this setting, Vault generates two minor narrative document versions:

• The first copies the previous version’s narrative.
• The second generates a new narrative for the follow-up record from the applicable Narrative Outline template.

Blind Protection

You can control blind protection for narrative documents with the Turn off Blind Protection on Narrative setting. When you enable this setting, Vault populates the Blind Protection field value of generated narrative documents with Off. This document field value determines the following:

• Off: Any information in the narrative document may be displayed in the Narrative Preview field.
• On: The Narrative Preview field does not display any sensitive information and unauthorized users cannot view the narrative document.

When Vault generates a narrative for a follow-up record, the new narrative document inherits the Blind Protection value from the narrative of the previous version unless the follow-up record was unblinded during processing. In this scenario, Vault always sets the Blind Protection field to On.

Optional: Update the Case Test Result Layout

Based on your business process, to all applicable Case Test Result and Localized Case Test Result object layouts, add the Include Result in Narrative? field. When users select No, Vault excludes that result from the generated narrative, if applicable to your Narrative Outlines.

Optional: Configure Case Access Group Security

If applicable, configure Case Access Group Security for the Case Summary Statement object. When any user regenerates a narrative for a follow-up Case, Vault upversions the narrative document and generates Case Summary Statements to track changes made since the action last ran, allowing users to review those changes in the upversioned narrative.