Sections in This Article
- About Inbox Item E2B Import
- Import an E2B Inbox Item
- Verify an E2B Imported Inbox Item
- E2B Import Suggestions
- E2B Import Source Data Pane
About Inbox Item E2B Import
When you create an Inbox Item from an E2B
.xml file, Vault Safety maps each E2B data element to populate the associated Vault Safety field. Because Inbox Items do not contain all Case fields, certain data does not appear until you promote the Inbox Item to a Case.
E2B Case Import Data Mapping describes how Vault Safety maps E2B data to a Case.
The following list outlines how you can import E2B files to create Inbox Items:
- Receive an E2B Transmission through an AS2 Gateway or Intake API
- Trigger the Create Inbox Item from Document action from an E2B document in the vault library
Once you create an Inbox Item from an E2B file, the system generates a CSV rendition of this E2B file.
Consider the following prerequisites for importing an Inbox Item from an E2B file:
- For vaults originally deployed in 21R1 or earlier, an admin must Enable E2B Import to Inbox Item.
.xmldocument in E2B format must already be in the Vault Library and the system must be finished generating a viewable rendition of the document.
.xmldocument must be uploaded using the Case > Source > Adverse Event Report classification and be in the New state in order to import the Inbox Item.
- The system library must contain the appropriate Organization, Product, and Study records. Otherwise, the system cannot properly map information to these records.
- To automatically code MedDRA terms when the E2B file contains reported medical terms with no MedDRA code, your vault must have an active Central MedDRA dictionary.
- Your vault must have the Allow Attachments option enabled for the Case > Source > Adverse Event Report document type in the Admin area.
Import an E2B Inbox Item
- Go to the document in the Vault Library.
Note The Create Inbox Item action is only available for the latest document version. The user action does not appear for older versions.
- Verify that the following document fields are populated:
- Organization: (Required) Select the Organization that will process the Inbox Item and Case.
- Receipt Date: (Optional) Select the receipt date. The system snapshots this field to the Inbox Item New Info Date. If you don't specify this field, the system sets it to the current date, by default.
- Report Type: (Optional) If not specified in the E2B data, select the report type. If you don't specify this field, the system sets the Report Type to Spontaneous on the Inbox Item by default.
The system uses the values in these fields to automatically populate the corresponding fields on the resulting Inbox Item and Case. If you don’t see the Receipt Date or Report Type fields, contact your administrator to add these fields.
- Ensure the system has finished generating a viewable rendition of the document.
Vault Help provides more information about viewable renditions.
- Once the viewable rendition is complete, expand the All Actions () menu, and then select the Create Inbox Item icon ().
Note If you don't see the Create Inbox Item user action, contact your administrator to ensure that the action has been made available.
The system imports the document to create an Inbox Item. Once created, the document Inbox Item field links to the Inbox Item and the system adds a link to the Inbound Transmission. The system also generates a CSV rendition of the E2B source data.
Learn how Case intake and Case promotion consider Inbox Items with Combination Products.
About the CSV Renditions of Imported E2B Files
The system generates a CSV rendition of the E2B file once you create an Inbox Item from this E2B. The rendition can be generated for E2B(R2) and (R3) files (for example, through manual upload, AS2 gateway, or API).
To access the CSV file, go to the E2B document in the Library. Select the Document Files icon () on the right panel. The CSV rendition is available in the Attachments section.
The CSV file contains E2B source data in a readable format. The following is an example snippet of a CSV file:
Note the considerations for CSV renditions:
- Elements that do not exist in the ICH E2B(R2) or (R3) guidelines are not included in the file.
- Embedded files for E2B(R2) are not supported.
- If the CSV rendition fails to generate, the E2B file will also fail to import.
- When viewing the rendition using your web-browser, long blocks of text (for example, case narratives) are truncated to around one-third of the page. The complete text block will be available in the downloaded CSV file.
Verify an E2B Imported Inbox Item
To verify the results on the E2B import, view the vault notification, and then verify the data on the Inbox Item.
When the Create Inbox Item from Document process is complete, the system logs a notification on the Home tab and sends an email notification with the results of the E2B import. To verify the operation succeeded, review the notification or email for the E2B import action.
If there are any issues mapping data from an E2B file, the notification includes a warning message explaining the affected E2B data element and value. If a mapping issue occurs, manually enter the information on the Inbox Item.
Verify an Inbox Item
- Go to the Inbox Item that you want to verify.
- Expand each section on the page to view the extracted data.
- Compare the extracted and suggested field values with the information in the Source Data panel to ensure the information is correct and valid.
- Use the following actions to correct and verify the data:
- To edit a field or address suggestions or conflicts, click into the field.
- To remove a section, select Delete.
- To mark a section as verified, select Verify.
Note If the item contains invalid data, the system prevents you from verifying this section and shows a message identifying the invalid values. You are not required to verify each section before Case promotion, however, if the Inbox Item contains invalid data, an error will appear when you promote to Case.
- Continue onto the next section for verification and repeat these steps until each section on the Inbox Item is verified.
You can easily enter additional data and add records manually while you verify the Inbox Item. Inbox Item Field Reference provides more information.
When you verify each section on an Inbox Item, you ensure that the data is valid. Select the Edit button to modify sections that you've already verified.
E2B Import Suggestions
While importing Inbox Items from E2B, Vault Safety generates suggestions to assist with processing the Inbox Item.
The system clearly identifies suggestions with a lightbulb icon, along with their confidence level and rationale to make verification easy.
Vault Safety can generate the following suggestions:
- Drug Role for Case Products
- Rank for Case Products
- Event Country for Medical Events
See Inbox Item Priority Auto-Calculation below to learn more about how priority is suggested.
Inbox Item Priority Auto-Calculation
Cases should be processed in a timely manner based on their priority. When there is a high volume of Cases, it is crucial to determine Case priority quickly.
The system auto-calculates and suggests the priority for new Inbox Items based on the adverse event seriousness provided in the source data. The following table outlines how the system assigns priority:
|P1||Results in Death
Other Medically Important Conditions
Seriousness information was not found
Edit an Inbox Item Priority
The user can verify the suggested priority while verifying the data in the Inbox Item. They can also change the priority.
- In the Inbox tab, select the Inbox Item you want to verify, and then expand the Details section.
- In the Priority field, select the dropdown menu, and then select the new priority for the Inbox Item.
The Inbox Item is assigned a new priority.
The user can display Inbox Items with a higher priority by filtering for these items. See Filter and Sort Inbox Items for more information.
E2B Import Source Data Pane
When an Inbox Item is imported from an E2B file, the Source Data pane shows the field values mapped from the E2B file:
The Source Data pane displays both short text and long text for structured data.