An in-flight Case is any open Case that is still being processed. This typically includes Cases in any state before Approved, Closed, and Superseded. Case Processors can merge new information from an Inbox Item to an in-flight Case. Vault creates an Inbound Transmission with links to the Case and Inbox Item. Upon merge, Vault updates the latest Case version to add a minor (+0.1) version number. For example, a Case with version (v1.0) becomes (v1.1). If multiple Inbox Items link to the same Case, Vault updates them so that they all link to the new Case version upon promoting an Inbox Item to follow-up, ensuring related Inbox Item information is not lost on subsequent versions.
If your Admin has configured your Vault to isolate blinded product information on Clinical Trial Study Cases, see Creating Follow-Up or Merging to Current Study Cases for additional considerations when completing these actions. For information on how Vault maps Japan-specific objects and fields when merging an imported file to an in-flight Case, see PMDA E2B(R3) Case Import.
Prerequisites
To merge to an in-flight Case, your Admin must:
- Enable the Merge to Active Case Version setting.
- Complete all enablement steps.
Merge an Inbox Item to an In-Flight Case
When merging an Inbox Item that has a link to an in-flight Case and is in the Marked as Follow-Up state, Vault skips duplicate detection and directs you to the Inbox Item to Case Compare page. When merging an Inbox Item that is not linked to a Case, Vault directs you to duplicate detection. From this page, you can select Compare Details to open the Inbox Item to Case Compare page.
To merge data on an Inbox Item into an in-flight Case:
- Navigate to the Inbox Item marked for follow-up.
- From the All Actions menu, select Promote to Follow-up.
- On the Inbox Item to Case Compare page, select the information from the Inbox Item you want to merge into the Case.
- Select the Merge to Current (
) icon.
Vault adds the changes you specified on the Inbox Item to Case Compare page to the latest Case version and completes the following:
- Updates the Inbox Item state from Marked as Follow-Up to Promoted. The Promotion Status section appears on the Inbox Item, which includes a link to the new Case version.
- Applies any changes to the primary designation for Case Product, Adverse Event, and Case Contact to the latest Case version.
- Reevaluates Case Assessments, Expectedness, and Assessment Results if the primary Case Product or Adverse Event changes.
- When configured by your Admin, attempts to auto-code any new External Products.
- Updates the narrative document.
- Retains compliant Transmission Due Dates by never updating the New Info Date after the merge.
If you do not see the Merge to Current icon, it may be due to any of the following reasons:
- The Case you want to merge into is in an Admin-defined prohibited state.
- You do not have permission to edit the in-flight Case in its current state.
- The Localization values on the Inbox Item and Case prevent them from being merged (Vault does not allow you to merge a global Inbox Item into a domestic Case).
Note: Vault prevents you from merging an Inbox Item to an in-flight Case that is locked to another user. However, you can create a follow-up version from the Inbox Item to Case Compare page.