You can merge Inbox Item information into an In-flight Case.

About Merging to an In-Flight Case

In-flight Case: An open Case that has not completed Case processing (generally in any state before Approved, Closed, or Superseded).

As a Case Processor, you can merge new Case information from an Inbox Item to an In-flight Case. Vault creates an Inbound Transmission with links to the Case and Inbox Item.

Vault also updates the latest Case version to add one 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. This ensures that 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 use the Merge to In-Flight feature, your Admin must:

Merge an Inbox Item to an In-Flight Case

  1. Go to the Inbox Item marked for follow-up.
  2. Run the Promote to Follow-up action.
    Since the Inbox Item is in the Marked for Follow-Up state and contains a link to an In-flight Case, Vault skips duplicate detection and directs you to the Inbox Item to Case Compare page.
    If the Inbox Item is not linked to a Case, Vault directs you to duplicate detection. From this page, you can select Compare Details to get to the Inbox Item to Case Compare page.
  3. On the Inbox Item to Case Compare page, select the information from the Inbox Item you want to merge into the Case. For more information on how to use Case Compare, see Inbox Item Follow-Up.
  4. When you’re done, select the Merge to Current icon.

Case Compare Merge to Current

When merging to an In-flight Case, the New Info Date is never updated after the merge. This supports retaining compliant Transmission Due Dates.

Result

The changes you selected on the Inbox Item to Case Compare page are updated on the latest Case version. If there are changes to the primary designation for Case Product, Adverse Event, or Case Contact, those are applied to the latest Case version. If the primary Case Product or Adverse Event changes, Vault reevaluates Case Assessments, Expectedness, and Assessment Results.

The Inbox Item state goes from Marked as Follow-Up to Promoted and a new section, Inbox Item has been promoted, appears with a link to the new Case version.