Learn how to generate E2B files in a readable format.
About Generating E2B Readable Renditions
Vault Safety maps case data to generate Individual Case Safety Reports (ICSRs) in compliant E2B XML formats. To support transmission document review, inspections, audits, and other routine quality checks, you can generate readable renditions of these files. These renditions offer clear organization and structure of the content. Renditions are available for all Vault Safety-supported E2B(R2) and E2B(R3) formats.
Generating readable renditions of E2B files is available when:
- The source file type is XML.
- The document classification is either:
- Case > Source Adverse Event Report
- Case > Individual Case Safety Report
You can download generated renditions as PDFs.
Prerequisite
To use this feature, your Admin must enable E2B Readable Renditions.
Readable Rendition Data Formatting
To display the E2B information clearly, Vault formats data types as follows:
| Data Type | E2B Coded Format | Readable Rendition Format |
|---|---|---|
| Date | YYYYMMDD, for example 20240930 |
DDMMMYYYY, for example 30SEP2024
When full dates are not available, Vault populates partial dates. |
| Date and Time | YYYYMMDDhhmmss-Z, for example 20240930103319-0400 |
DDMMMYYYY hh:mm:ss, for example 30SEP2024 10:33:19
When full dates are not available, Vault populates partial dates. |
| Boolean | TRUE |
Yes |
| Boolean | FALSE |
No |
| E2B Code | N, for example 1 |
Code [N], for example Spontaneous [1] |
| Text | Vault exports text as it appears in the applicable Case field. | Vault exports text as it appears in the applicable Case field. |
| Number | Vault exports numbers as they appear in the applicable Case field. | Vault exports numbers as they appear in the applicable Case field. |
For masked or blinded information in the XML format, Vault masks or blinds the information in the PDF.
Generate E2B Readable Renditions
You can generate readable renditions of E2B files in XML format through the Library or the Submissions & Distributions section of Cases or Localized Cases. To generate a readable rendition, navigate to the Transmission document you want to render more readable and, from the All Actions menu, select Generate E2B Readable Rendition.
Vault sends an email and displays a notification when the readable document is ready for viewing.
Download E2B Readable Rendition
You can download readable renditions of E2B files in PDF format. Download files from Vault notification messages or:
- Navigate to an E2B document with a generated E2B Readable Rendition PDF.
- From the Doc Info page, select the Document Files panel icon.
- Expand the Renditions section.
- Select the E2B Readable Rendition.
Vault downloads the PDF to your local computer.