Import an Inbox Item from an E2B File

Vault Safety can import .xml files in E2B (R2) or (R3) format to create Inbox Items.

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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

    Note Automated Case promotion is possible for Inbox Items received through an AS2 Gateway Transmission if Enable Auto Promote is on. User intervention, such as Inbox Item data entry and selecting the Promote to Case action, is not required for this process.>Automated Case promotion.

  • Trigger the Create Inbox Item from Document action from an E2B document in the vault library

Prerequisites

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.
  • The .xml document in E2B format must already be in the Vault Library and the system must be finished generating a viewable rendition of the document.

    Note The .xml document must be uploaded using the Case > Source > Adverse Event Report classification and be in the New state in order to import the Inbox Item.

    Add a Document provides instructions on adding documents to the library.
  • 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.

Import an E2B Inbox Item

  1. 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.

  2. 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.
  3. Ensure the system has finished generating a viewable rendition of the document.
    Vault Help provides more information about viewable renditions.
  4. Once the viewable rendition is complete, expand the All Actions (All Actions) menu, and then select Create Inbox Item.

    Note The Create Inbox Item from Document user action label may differ depending on your Vault configuration. If you don't see this user action available, contact your administrator to ensure that the action has been made available.

Result

The system imports the document to create an Inbox Item. Once created, the document Inbox Item field links to the Inbox Item. The system also creates and adds a link to the Inbound Transmission.

Learn how Case intake and Case promotion consider Inbox Items with Combination Products.

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.

Vault Notification

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

  1. Go to the Inbox Item that you want to verify.
  2. Expand each section on the page to view the extracted data.
  3. Compare the extracted and suggested field values with the information in the Source Data panel to ensure the information is correct and valid.
  4. 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.

  5. 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.

Result

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.

AI Suggestion
Inbox Item Import Suggestion

Vault Safety can generate the following suggestions:

  • Drug Role for Case Products
  • Rank for Case Products
  • Event Country for Medical Events
  • Priority
    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:

Priority Level Seriousness
P1 Results in Death

Life Threatening

P2 Caused/Prolonged Hospitalization

Disabling/Incapacitating

Congenital Anomaly

Birth Defect

Other Medically Important Conditions

P3 Not Serious

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.

  1. In the Inbox tab, select the Inbox Item you want to verify, and then expand the Details section.
    Verify Priority
    Inbox Item priority
  2. In the Priority field, select the dropdown menu, and then select the new priority for the Inbox Item.
    Change Inbox Item Priority
    Change the Inbox Item Priority

Result

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:

E2B Import Source Data Pane
E2B Import Source Data Pane

The Source Data pane displays both short text and long text for structured data.


Manual Inbox Item Intake
Perform Local Language Intake
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