Compose a Case Narrative

Edit case narratives on your local machine or directly in your browser with Microsoft 365.

Narrative Generation

As part of the process to create a Case, Vault Safety generates a narrative document, uploads the file to the library, and links the file to the case. For cases generated from an imported E2B file, all narrative text is automatically populated in the narrative.

For Domestic Cases, Vault Safety generates a localized and English narrative document upon Case promotion. See Prepare a Domestic Case for more information on narrative documents on Domestic Cases.

By default, the narrative is a blank document that you can use to write the case narrative using Vault’s advanced document management capabilities. However, your Admin can customize the narrative template used to generate the narrative document to align with organizational requirements. Configure Narrative Templates provides information.

If the Case is based on an imported E2B file, any narrative text and any translations from the E2B file are automatically imported.

When you create a Follow-Up Case, Vault copies the previous version of the narrative and translations into the new Case. For E2B-imported Follow-up Cases, the content in the H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information data element is appended to the end of the existing narrative. The narrative and any translations are populated into generated reports.

Case Access Groups

When a Narrative document is generated and uploaded to the library, Vault populates the Case Access Group field on the document. The Case Access Group is inherited from the associated Case and is read-only.

To view the Case Access Group for a document, go to the Document Information pane, expand the Case Information section, and check the Case Access Group field.

Edit the Narrative Document

1. Go to the Case page.
2. Expand Narrative.
3. Beside Narrative Document, select the document link.
   If the Narrative document is under the Narrative Section of a Domestic Case, the document link will appear beside the Narrative Preview dual-language field
   The narrative document appears.
4. Edit the document as required.
   Adding Documents provides more information.

Add a Narrative Translation

If the Case is based on an imported E2B file, all narrative translations from the E2B file are automatically imported.

To manually add a narrative translation, complete the following steps:

1. From the Case page, expand Documents and select Add.
2. In the Search: Documents window, select Create.
3. On the Upload Files (Step 1) page, drag and drop the file into the blue area or select Choose to browse for the file on your device.
   The document must be a .docx file.
4. Choose Case › Summary › Narrative as the document type, and then select Next.
5. On the Upload Files (Step 2) page, complete the following fields and select Save:
   • Language: Select the language of the translation.
     When you save the document, its name includes the language.
   • Organization: Select the organization associated with the Case.
6. Return to the Case page and under Narrative, select the Case Narrative document to which you want to add this translation.
7. On the Narrative document page, expand Supporting Documents and then select .
8. Search for the narrative translation you saved and select the checkbox next to it to attach it to the narrative, and then select Close.

Result

The narrative translations appear in the narrative document Information pane, under Supporting Documents.

Recommendations and Best Practices

Consider the following recommendations and best practices while you compose a case narrative:

• Do not add information that should be blinded to the narrative document. Blind protection is not set on the narrative document by default.
• Do not add comments or track changes in the Word 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.

Narrative Generation Known Issue

When generating a narrative document with merge field tokens, if any token cannot resolve, all tokens with the same filter cannot be resolved. This issue includes having a specific filter or having no filter. For example, if the unresolved token has no filter, all other tokens with no filter are impacted. This is a known issue that will be fixed in a future release.

Re-Render the Narrative Document

When Case details are added or changed, you can update merge fields on the Case narrative using the Re-render Case Narrative (rerender_case_narrative__v) action.

1. From the Case, expand the All Actions menu, and then select Re-render Case Narrative ().
   If you do not see this action your Admin may need to configure the Re-render Case Narrative action.
2. On the Re-render Document dialog, select OK.

Result

The Narrative Document is updated with new details.

Lock Merge Field Tokens from Re-Generating

Before you distribute a Case to health authorities, we recommend that you move the narrative document to a steady-state, such as Approved, to save the narrative to a version in time and prevent further changes to the content. If future updates are required, you can create a new version of the document.

Once a document enters a steady-state, merge field tokens will not regenerate if there are any changes to the associated fields. This is especially important if you must make future revisions to the Case, such as non-significant follow-ups or amendments, after already distributing the case to partners or health authorities.

How to Move a Narrative to Steady-State

You can move the narrative document to a steady-state by completing the document workflow. Typically, this involves starting a review and then approving the document.

Access user actions to move the document to a new state from the Workflow State Change Menu () on the Action Bar. User actions may be labeled Start Review and Approve, or differently depending on your Admin’s configuration.

About the Narrative Preview Field

After you compose 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

When the Blind Protection is set on the Narrative Document, the Narrative Preview on the Case stops being updated and is prepended with [Blind Protection]. Unauthorized users cannot view the narrative document when Blind Protection is enabled. Vault sets the Blind Protection document field based on your Admin’s configuration.

If your Admin has configured blind protection on Narrative documents, the Case Narrative Preview does not display any sensitive information. When Vault generates a Narrative for a Follow-up to a blinded Case that was unblinded during Case processing, Vault sets the Blind Protection field on the Follow-up Narrative document to On. For all other scenarios, when Narratives are generated for Follow-up Cases, the new Narrative copies the blind protection setting from the Narrative on the previous Case version.

If your Admin has turned off blind protection on Narrative documents, any information in the Narrative document may be included in the Narrative Preview. When Narratives are generated for cases, blind protection remains off.

Regardless of blind protection, if the initial Narrative contained merge fields, the tokens are regenerated using the new information in the Follow-up Case.

Generally, sensitive information that should be blinded, such as product name tokens, should not be added to the narrative document. We recommend that you set up a blinded narrative template without any sensitive tokens.

Follow-Up Narratives

When a Follow-Up Case is opened, Vault Safety copies over the most recent version of the narrative document from the initial Case.

If a Local Inbox Item is being merged to a Follow-up Case, any localized narrative content is appended to the narrative document from the initial Case and copied over to the Follow-up Case. For this process to work, the language of narrative content in the Inbox Item and the initial Case must be the same.

If the initial narrative contained merge fields, the tokens are regenerated using the new information in the Follow-Up Case.

Copy Merge Fields Without Regenerating Values

To include the initial Case narrative without regenerating token values from the initial case, perform the following steps:

1. Go to the initial Case narrative document.
2. Copy the text from the initial narrative.
3. Paste the contents into the Follow-Up Case narrative using plain text without formatting.
   You must paste with plain text to ensure the tokens are not regenerated.