Enable Destination-Specific Case Document Management Improvements

Learn how to configure which documents Vault transmits to specific destinations and in follow-up scenarios during E2B(R3) generation.

About the Feature

With the 25R1 release, Vault Safety offers enhanced control of literature article and attachment inclusion in generated E2B(R3) files based on the reporting destination. In addition, Vault Safety now streamlines Localized Case Document creation, which supports processing Localized Cases related to Cases with literature information exported from SafetyDocs.

You can now configure your Vault with the following functionality:

  • Exclude document contents that were previously included in a transmission for a destination and case, improving compliance during follow-up scenarios.
  • Configure attachment types that are specific to a single destination. For example, you can include Death Investigation Reports (DIRs) on Transmissions to the National Medical Products Administration (NMPA) for China domestic Cases and exclude them from Transmissions to other destinations for that Case.
  • Allow users to copy all documents from a global Case to a related Localized Case using the new Generate Localized Case Documents action.

After configuring this feature, see the following articles for more information:

Update Transmission Profile Layouts

To all applicable Transmission Profile object layouts, add the following fields to the Details section:

  • Literature Inclusion Control
  • Attachment Inclusion Control
  • Destination Specific Attachment Type

Update Transmission Layouts

To all applicable Transmission object layouts, insert the Destination Specific Document Inclusion related object section.

Configure the Generate Localized Case Documents Action on Localized Cases

To configure the Generate Localized Case Documents action, first assign the action to the Localized Case object. Then, based on your business process, you can add the action as a user action and entry action to the applicable states of the Localized Case Lifecycle object lifecycle.

Optional: Add Custom Attachment Types

On Transmission Profiles, Vault includes the following document Attachment Types:

  • China Death Certificate
  • FDA Carton Attachment
  • PMDA JPPI

To configure additional Attachment Types:

  1. Navigate to Business Admin > Picklists > Attachment Type.
  2. Select Create.
  3. In the Picklist Value Label field, enter a name for the Attachment Type.
  4. Select Save.