Sections in This Article
- Narrative Generation
- Edit the Narrative Document
- Add a Narrative Translation
- Recommendations and Best Practices
- Lock Merge Field Tokens from Re-Generating
- About the Narrative Preview Field
- Blind Protection Field on the Narrative Document
- Follow-Up Narratives
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, an administrator 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, the system copies the previous version of the narrative and translations into the new Case. The narrative and any translations are populated into generated reports.
Note Narrative documents, including translations, must be in the
.docx file format. The
.docx format is the only format supported for generating reports (CIOMS I, FDA 3500A, and E2B) and the Narrative Preview field.
Edit the Narrative Document
- Go to the Case page.
- Expand Narrative.
- 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.
- Edit the document as required.
Edit a Document 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:
- From the Case page, expand Documents and select Add.
- In the Search: Documents window, select Create.
- 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
- Choose Case › Summary › Narrative as the document type, and then select Next.
- 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.
The narrative translations appear in the narrative document Information pane, under Supporting Documents.
Recommendations and Best Practices
Tip See the Narrative Preview field for how the narrative will look once exported to a regulatory report.
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.
Note If you see merge field queries in the narrative, contact Veeva Services or your administrator. There may be a configuration issue on the narrative template.
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 vault’s configuration.
About the Narrative Preview Field
After you compose a narrative, the system updates the Case Narrative Text field 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 Text field can contain up to 32 thousand characters. If the narrative includes a table, the system 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. The system does not automatically set the Blind Protection document field.
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.
When a Follow-Up Case is opened, Vault Safety copies over the most recent version of the narrative document from the initial Case.
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:
- Go to the initial Case narrative document.
- Copy the text from the initial narrative.
- 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.