Enable Rules Based Narrative Generation

Learn how to enable your Vault to generate rules based narratives from outline templates based on Case data.

About the Feature

With the 25R1 release, you can configure rules for narrative generation based on Case data. Create Narrative Outline templates composed of Narrative Statements, each with its 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 related Case 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 the Case 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:

25R2 Updates

With the 25R2 release, Vault introduces the following new features:

  • Rules Based Narratives Enhancements: You can copy sample outlines and their related statements and options using the Copy Narrative Outline action. See Configure Actions on Narrative Outline to configure your Vault for the updated feature and Configure Rules Based Narratives to download the sample files.
  • Previous Case Version Narrative on Follow-Up: 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 the Generate Narrative from Outline action
  2. Configure actions on Narrative Outline
  3. Update the Case Compare Page
  4. Define settings for follow-up Case narratives
  5. Optional: Update the Case Test Result layout
  6. Optional: Configure Case Access Group Security

Configure the Generate Narrative from Outline Action on Case

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 (1) 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.

>Remove the Re-Render Case Narrative Action

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

Configure Actions on Narrative Outline

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

Add the following fields to the Case Compare Followup layout for the Inbox Item to Case Compare page so that users can review changes to follow-up statements:

  • Details section:
    • Primary Event Seriousness
  • Patient section:
    • Date of Birth (normalized)
  • Adverse Events section:
    • 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 Follow-Up Narratives

You can define settings to specify which minor narrative document versions Vault generates when users create a follow-up Case. For non-E2B sources, you can specify that Vault generates a single narrative document by copying the previous Case’s narrative and does not generate a new narrative from the outline template. To enable this setting in your Vault:

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

If you do not enable this setting, Vault generates two (2) minor narrative document versions:

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

Optional: Update the Case Test Result Layout

Based on your business process, to all applicable 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 Follow-Up Statement object. When any user reruns the Generate Narrative from Outline action on a follow-up Case, Vault upversions the narrative document. Vault also generates Case Follow-Up Statements to track changes made since the action last ran, and includes those statements in the upversioned narrative.