Veeva Safety can generate Inbox Items from imported E2B(R2), E2B(R3), and non-E2B files in your Library.

Updates

We have added the following updates to this feature:

  • Duplicate E2B XML File Detection: With the 24R3 release, you can configure your Vault to detect duplicate files imported from a multi-E2B or ZIP file.

Overview

Complete the following procedures to enable this feature in your Vault:

Configure the Create Inbox Item Document Action

The Create Inbox Item from Document user action for document lifecycle states allows users to generate Inbox Items from files in your Library. Depeding on your business needs, you can configure this action in the following ways:

  • To generate Inbox Items from E2B files, configure the action on the New state of the AER Lifecycle. You can also configure the action on additional states and lifecycles associated with the Case > Source > Adverse Event Report (AER) document type, depending on your business needs. When executed, Vault generates Inbox Items populated with values mapped to the E2B data elements.
  • To generate Inbox Items from non-E2B files, such as PDF literature reports, configure the action on the Imported state of the Case Source Lifecycle. When executed, Vault creates a blank Inbox Item for manual intake. This also allows users to generate Inbox Items from document placeholder records and capture the citation in the Reference field of the document’s metadata.

Configure Document Types

Depending on which lifecycles you configured the Create Inbox Item from Document action, you must configure the applicable document types to allow attachments:

  • If you configured the action to generate Inbox Items from E2B files, the Case > Source > Adverse Event Report (AER) document type (associated with the AER Lifecycle).
  • If you configured the action to generate Inbox Items from non-E2B files, the Case > Source > Literature document type (associated with the Case Source Lifecycle).

Enable Localization-Based Mapping

To support local import from E2B and Vault API sources, you must enable the Enable Localization-based Mapping on Import Safety general setting. When enabled, Vault maps the localized data in the imported source files to the corresponding localized Inbox Item fields. You can also specify this behavior at a granular level for individual Transmission Profiles, which overrides the setting for the associated imported files.

Duplicate E2B XML File Detection

Vault can detect duplicate XML files when importing multi-E2B and ZIP files when the Enable E2B Document Duplicate Detection field value is Yes for the reporting Organization’s associated Transmission Profile. When this field value is Yes, Vault detects duplicate files that users already successfully imported and creates the Inbox Items in the Duplicate lifecycle state. Vault also links each duplicate file to the original version already in your Vault. To support this:

  • Ensure the Enable E2B Document Duplicate Detection field displays on the following Transmission Profile object layouts:
    • AS2 Gateway Detail Page Layout
    • Connection Profile Page Layout
    • Inbound Email Page Layout
    • Partner Exchange Profile Page Layout
    • System Gateway Detail Page Layout
  • Update the Enable E2B Document Duplicate Detection field value to Yes on the applicable Transmission Profiles.

Update the Case Object Layout

For the Imported Case Page Layout for the Case object layout, ensure the following:

  • Object Layout:
    • The Details section includes the Study field.
    • The Contacts section includes the following Criteria VQL: object_type__vr.api_name__v CONTAINS ('reporter__v', 'health_care_professional__v', 'patient_contact__v', 'facility__v', 'base__v')
  • Layout Rules:
    • IF this Layout Rule Expression is TRUE: Or(Text(report_type__v) = "Spontaneous", Text(report_type__v) = "Other", Text(report_type__v) = "Literature (Spontaneous)")
    • Apply the following display effects: Hide the Study and Study Registrations sections.