Generate a Case Narrative

Generate case narratives based on Admin-defined templates and edit them on your local machine or directly in your browser with Microsoft 365.

About Narrative Generation

Vault may automatically generate narratives when you create a Case or move a Case to a specific lifecycle state. If configured by your Admin, you may also be able to manually generate and update a narrative. The content included in generated narrative documents depends on your Admin’s configuration. You can review all versions of the document and, if applicable, edit the document in your library.

Depending on your Admin’s configuration, Vault may generate narrative documents in the following ways:

• Rules based narratives
• Narrative templates

Narrative Preview Field on the Case

After you generate a narrative, Vault updates the Narrative Preview field on the Case with a plain text preview of the narrative document. This preview shows how the narrative will be exported in generated regulatory reports, such as CIOMS I, FDA 3500A, and E2B. The Narrative Preview field can contain up to 32,000 characters. If the narrative includes a table, Vault replaces the table dividers with commas in the preview.

Blind Protection Field on the Narrative Document

If your Admin has configured blind protection on narrative documents, the Blind Protection field value of the narrative document is On, the Narrative Preview field does not display any sensitive information, and unauthorized users cannot view the narrative. When Vault generates a narrative for a follow-up Case, the new narrative document inherits the Blind Protection value from the narrative of the previous Case version unless the follow-up Case was unblinded during processing. In this scenario, Vault always sets the Blind Protection field to On.

Bulk Unblinding

Whenever you bulk unblind all Cases in a Study, Vault generates two (2) minor document versions:

• The first copies the previous Case’s narrative.
• The second appends the Narrative Text value to the end of the document.

Case Access Groups

If your Admin has configured Case Access Group Security, Vault populates the Case Access Group field in the Case Information section of the Doc Info pane on generated narrative documents based on the corresponding value of the associated Case. You cannot update this field value.

Rules Based Narratives

When you run the Generate Narrative from Outline action on a Case, Vault generates a narrative based on Admin-defined outlines that include specific elements of a Case. These narratives are grammatically correct, logical, orderly, and complete, while requiring minimal editing. Your Admin can configure outline templates for different types of Cases and optionally for different locations and organizations. Depending on your Admin’s configuration, this action may run automatically when you create a Case or move a Case to a specific lifecycle state. If configured, you can manually run this action by selecting it from the All Actions menu of a Case. For more details, see Configure Rules Based Narratives.

When the Generate Narrative from Outline action runs, Vault generates a narrative document based on your Admin’s configuration. Whenever you run the action on a Case that already has an associated narrative document, Vault re-renders and upversions the existing narrative document based on the applicable outline template. You can review any changes to follow-up statements on the Case Version Compare page. The upversioned narrative includes a summary of any changes to the Case between major versions, including updates to the following:

• Patient details
• Added studies
• Adverse events and changes to seriousness
• Suspect product details
• Assessment results
• Drug histories
• Treatment drugs
• Medical histories

The following behavior applies to generating rules based narratives:

• For Cases promoted from imported Inbox Items with E2B narrative content, you can review the source E2B narrative in the previous version.
• When you create a follow-up Case, Vault generates two (2) minor narrative document versions:
  • The first copies the previous Case’s narrative.
  • The second appends the Narrative Text value to the end of the document.

Types of Cases

Vault matches the appropriate Admin-defined outline template to Case data for the following types:

• Post-Market Non-Serious: Applies to the following Cases:
  • Postmarket Cases (do not have Studies)
  • Non-clinical trial study Cases (Study Type is Other) with a Serious value of No or blank
• Post-Market Serious: Applies to the following types of Cases:
  • Postmarket Cases (do not have Studies)
  • Non-clinical trial study Cases (Study Type is Other) with a Serious value of Yes
• Clinical: Applies to clinical trial study Cases (Study Type is not Other)

Limitations

Vault can reference up to 15,000 child Case Products and 15,000 Case Medical Histories per Admin-defined Narrative Statement Option. If executing a particular record would exceed this amount, Vault ignores that option when generating the narrative and sends you a notification with details about which record would have exceeded this limitation.

Narrative Templates

When you promote an Inbox Item to a Case, Vault generates a narrative based on Admin-defined controlled document templates using merge fields that generate values based on token resolution. Your Admin can configure custom templates for any combination of Organization, Report Type, Study Type, Study, and Localization. For more details, see Configure Narrative Templates.

The following behavior applies to generating narratives from narrative templates:

• For Cases promoted from imported Inbox Items with E2B narrative content, the generated narrative includes imported narrative text and translations.
• When you create a follow-up Case, Vault re-renders the narrative from the initial Case, creating a new follow-up narrative document version for the follow-up Case.
  • For follow-up Cases with imported E2B content, Vault appends the content in the H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information data element to the end of the narrative.
  • If you merge a local Inbox Item to a follow-up Case and the language for the Inbox Item’s narrative content and initial Case are the same, Vault copies the narrative content from the initial Case to the new narrative document and appends any localized narrative content to the new document.

Follow-Up Narratives

When you open a follow-up Case Vault copies over the most recent version of the narrative document from the initial Case. If the first narrative contains merge fields, Vault updates the field values in the second narrative version using the information in the follow-up Case. To include the initial Case narrative without regenerating merge field values, perform the following steps:

1. Navigate to the initial Case narrative document.
2. Copy the text from the initial narrative.
3. Paste the contents into the narrative document for the follow-up Case using plain text without formatting. You must paste with plain text to ensure Vault does not regenerate merge field values.

Localized Narratives

Vault generates narrative documents for the translation of Localized Cases, which includes the English narrative that exists for the related Case when you generate the Localized Case. You can review these details and access the narrative document in the Narrative section.

You can override a Localized Case’s narrative content by selecting the Sync Global Narrative to Local Narrative action from the record’s All Actions menu. This updates the narrative document with the most-recent version from the related global or domestic Case.

Re-Render the Narrative Document

After adding or changing Case details, you can run the Re-render Case Narrative action to update merge fields on the narrative. To do this:

1. Navigate to the Case.
2. From the All Actions menu, select Re-render Case Narrative.
3. In the Re-render Document dialog, select OK.

When you re-render the narrative document, Vault does not create a new document version. Instead, Vault updates merge fields in the most-current version of the document to reflect the new details.

Lock Merge Fields

Before you distribute a Case to health authorities, we recommend moving the narrative document to a steady-state to save the narrative to a specific version in time. This prevents Vault from updating merge field values in the narrative document if any of the associated fields on the Case change, such as non-significant follow-ups or amendments. If you need to update the narrative document after distribution to partners or health authorities, you can create a new version of the document.

Use the narrative document’s workflow to move it to a steady state, such as Approved.

Accessing and Reviewing the Narrative Document

After Vault generates or updates a narrative document, you can review the document, including any previous versions. You can access the generated DOCX narrative file in your Library and directly from the Narrative section of a Case or Localized Case.

Edit the Narrative Document

You can edit generated narrative documents using collaborative authoring.

Recommendations and Best Practices

We recommend the following best practices when editing a narrative document:

• Do not add information that should be blinded to the narrative document.
• Do not add comments or track changes in the document. If you need to use these review tools for draft purposes, ensure you remove them for the final version.
• To copy-paste content with merge field tokens, paste without formatting. If you paste with formatting, the tokens will regenerate if there are changes to the associated field.
• Do not insert images into the document.
• If you must insert tables, only use single-column tables. Multi-column tables cannot be exported to transmission documents. When tables are exported, they are flattened to comma-separated text values.

Add a Narrative Translation

If the Case is based on an imported E2B file, Vault imports all narrative translations from the E2B file. To manually add a narrative translation:

1. Navigate to the applicable Case.
2. In the Documents section, select Add.
3. In the Search: Documents window, select Create.
4. On the Upload Files (Step 1) page, select the applicable DOCX file.
5. For Choose document type, select Case › Summary › Narrative.
6. Select Next.
7. On the Upload Files (Step 2) page, populate the following fields:
   • Language (ISO)
   • Organization
8. Select Save.
9. In the Narrative section of the Case, select the document to which you want to add this translation.
10. In the Supporting Documents section of the Doc Info page, select the plus () icon.
11. Search for the narrative translation you saved and select the checkbox next to it to attach it to the narrative.
12. Select Close.

The narrative translations appears in the Supporting Documents section of the Document Information panel.