Inbox Item Follow-Up

You can compare Inbox Item data to the previous Case version when creating Follow-up Cases.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Inbox Item Follow-Up

When you choose to promote an Inbox Item to a Follow-up Case, the Inbox Item to Case Compare page appears. This page allows you to compare all the data from the Inbox Item with the data on the previous Case version.

Information from the Inbox Item can then be merged with the previous Case version to create a Follow-up Case. You can compare data from standard and custom fields at the Case level as well as from child records (such as Case Adverse Events).

The Inbox Item to Case Compare page also appears when you choose to merge an Inbox Item to an In-Flight Case.

By default, to promote an Inbox Item to a Follow-up Case, the WWUID on the Inbox Item must match the WWUID on the Case. However, your Admin can configure your Vault to enable Case promotion for an Inbox Item that contains mismatching WWUIDs with the previous Case version. If the Inbox Item WWUID value is not found in a Case Identifier on the matching Initial Case, Vault snapshots the Inbox Item WWUID to a Case Identifier upon promoting to a Follow-up Case.

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 creating a Follow-up Case from an imported file, see PMDA E2B(R3) Case Import.

Prerequisites

To use the Inbox Item Follow-up feature, your Admin must enable Inbox Item Follow-up Case compare.

Note: Your Admin can configure the Inbox Item Follow-up Case Compare layout to choose which fields are available for merging to follow-up.

About the Inbox Item to Case Compare Page

The following image represents the Inbox Item to Case Compare page:

The Inbox Item to Case Compare page is divided into two main sections:

Inbox Item [Inbox Item ID]: Contains data from the Inbox Item.
Matching Case [Case ID]: Contains data from the previous Case version merged with the new data on the Inbox Item, to present the modified information that will form the Follow-up Case.

Note: If you leave this page, Vault does not save any changes you made.

The left sidebar displays the filters, legend, and section headers.

Data rows highlighted in blue represent new or changed information whereas the orange rows represent information missing on the Inbox Item that exists on the previous Case version.

For each section in the left sidebar, the number of records appears. For example, Products (4) indicates there are four (4) Product records. Once an object exceeds 500 records, Vault does not display the records on the Inbox Item to Case Compare page. However, you can still see the number of records in the left sidebar and Vault still promotes these records using the default merge behavior.

Legend

The legend describes what each color signifies on the Inbox Item to Case Compare page.

Data rows highlighted in blue represent new or changed information. Data rows highlighted in orange represent information missing on the Inbox Item that exists on the matched Case version.

Filters

When you are first directed to the Inbox Item to Case Compare page, the new and modified data are displayed. Your Admin may have configured different filters to display by default. The page contains the following filters:

Show New displays data that is not present on the previous Case version but is populated on the Inbox Item, including any new Case child records.
Show Modified displays data that was changed between the previous Case version and the Inbox Item, including any modified Case child records.
Show Unchanged displays Case fields and child records that did not change between the previous Case version and the Inbox Item.
Show Empty displays fields that are blank on both the previous Case version and the Inbox Item.
Show Missing displays data from the previous Case version that is not present on the Inbox Item, including any case child records that are missing on the Inbox Item but present on the previous Case version.

Visual Indicators

The following table outlines visual indicators you may see on the Inbox Item to Case Compare page:

Icon	Description
	This tag indicates new information from the Inbox Item that doesn't exist on the previous Case version.
	This tag appears when you delete field information for the Follow-up Case.
	This tag indicates the field was set to Reason Omitted.
	This tag indicates Vault automatically calculated a field using information entered in other fields.
	This tag indicates Vault automatically calculated Combination Product-related information.
	This tag indicates Vault automatically calculated Study-related information.
	Data displayed as bullets indicates you do not have access to these fields on the Case or child records due to atomic security.

Accept Changes

Use the Accept Change checkboxes to choose the information from the Inbox Item to add or modify the new Case version. If a row does not have a checkbox, there is no change in data.

If the matching Case is locked by another user and this user makes updates to the Case while you are on the Inbox Item to Case Compare page, this page does not reflect the latest Case data until you refresh it.

When you create a Follow-up Case, Vault displays a warning message to indicate the user who locked the Case may still be making changes to it.

Note: When an Inbox Item contains Case Identifiers with leading or trailing spaces (for example, “NN-ABCD-123 “), although the values appear identical to the original Case, Vault processes the data as an update, rather than an exact match. This is a known limitation that will be addressed in a future release.

Blinded Product Matching

When matching a blinded Product record on a Case to another Case record, Vault first tries to match based on the Study Product Placeholder. If the Study Product Placeholder on the Case is blank, Vault tries to match based on the Product (Reported) value.

Merge Behavior

The following sections provide information on how Vault merges Inbox Item data to Follow-up Cases.

Case Narratives

Vault copies Narratives from previous Case versions to Follow-up Cases and appends narrative content from Inbox Items. This also applies to localized narrative content. If the E2B file from which an Inbox Item was created contains any localized narrative content, Vault appends it to the narrative copied from the previous Case version.

When merging an Inbox Item into an in-flight Domestic Case through the Inbox Item to Case Compare page, if the Localization value does not match, Vault updates the Language (ISO) field on the Narrative to the language that matches the Localization value of the Inbox Item. To update the Narrative document, Vault copies the narrative content from the previous Case version and appends any new content from the Inbox Item. This situation may occur, for example, if the Localization value on the initial Case is incorrect.

Reason Omitted Fields

Fields that were set to Reason Omitted are displayed with an RO Tag tag. Reason Omitted fields are not promoted over fields with data.
The following table describes the default behaviors associated with Reason Omitted fields:

Inbox Item	Matching Case	Output
Asked But Unknown	Not Asked	Asked But Unknown
Asked But Unknown	Verteo Biopharma	Verteo Biopharma
Verteo Biopharma	Not Asked	Verteo Biopharma
Asked But Unknown	Blank	Asked But Unknown
Blank	Not Asked	Not Asked

Missing Information

When field information is missing on the Inbox Item but is present on the previous Case version, Vault deselects the checkbox by default. This will promote the field with data from the previous Case version.

Atomic Security

You may not have access to certain fields on the Case or child records due to atomic security (for example, on unblinded Cases). These fields are displayed as bullets. The checkbox is inactive and the system will use the default behavior depending on the type of change. You may want to have a user with greater permissions for promote to follow-up to modify these fields.

You can override Vault selections by selecting or deselecting the checkboxes (except for the fields with atomic security configured).

Auto-Calculations

Vault automatically calculates certain fields on the Inbox Item to Case Compare page, which are displayed with an auto-calc Tag , Combo Tag , or Study Tag tag. These fields include Combination Product-related and Study-related information.

Before merging the Inbox Item to a Follow-up Case, you can override the default behavior by clearing the checkbox to prevent the system calculation from promoting to Case.

An Inbound Transmission
A Case Unique Number
Assessments and Assessment Results
Auto-expectedness and Expectedness Records
Watchlist tags
Case tags

Note: Default Vault behavior can cause unblinded Study Products to be blinded upon merging to Follow-up. This is a known issue that will be fixed in a future release.

Your Admin can disable the auto-calculations that occur for certain fields during Case promotion of an Inbox Item. Once this option is disabled, the Inbox Item to Case Compare page will not display any auto-calculated values and the field will be left blank upon promotion. See the Auto-Calculations Field Reference for the affected fields, excluding the following:

Expectedness (expected__v)
Listedness (listedness_from_core_datasheet__v)
Relatedness (relatedness__v)
Assessment Tag (assessment_tag__v)
Watchlist Tags (watchlist_tags__v)

Localization

If the previous Case version has any Localized Cases, Vault uses the following logic upon Follow-up Case promotion:

If the previous Case version is a global case, the new Follow-up Case retains the Global Localization value (blank).
If the previous Case version is a Domestic Case, the new Follow-up Case inherits the previous Case version’s Localization.

Note: Your Admin can configure the following behavior: If a previous Case version is a global Case but the Inbox Item Localization field is set to a Local value, Vault creates a Domestic Case upon Follow-up Case promotion.

Localized Data

When promoting a Local type Inbox Item to a Domestic Follow-up Case, Vault carries over all global and localized data along with all related child records to the new or Follow-up Case. This feature is automatically available in Vaults with Domestic Case Processing and Local Case Import to Inbox Item enabled.

When promoting a Global type Inbox Item (Localization is blank or Global) to a Domestic Follow-up Case, Vault carries over all global data with all related child records to the new or Follow-up Case.

The logic that the system uses to carry over localized data depends on the action you select on the Inbox Item to Case Compare page.

Create New Case

When you select this action, Vault carries all localized data from the Local type Inbox Item or global data from the Global type Inbox Item over to the initial Case version that is created.

Create Follow-Up

For Local type Inbox Items, when you select this action, Vault merges all localized data from the Inbox Item and previous Case version and carries it over to a new Domestic Follow-up Case. Any new localized fields in the Inbox Item that did not exist in the previous Case version are copied over to the new Follow-up Case. Similarly, any localized fields in the previous Case version that do not exist in the Inbox Item are also carried over to the new Follow-up Case.

For Global type Inbox Items, when you select this action, Vault merges all global data from the Inbox Item and localized data from the previous Case version and carries it over to a new Domestic Follow-up Case. Vault sets the Follow-up Case’s Localization value using the previous Case’s localization (Local).

For additional considerations when creating Follow-up Cases, see Updating Parent Information.

Merge to Current

For Local type Inbox Items, when you select this action, Vault carries all localized data from the Inbox Item to the In-flight Domestic Case based on your merge decisions on the Inbox Item to Case Compare page. This means that if you add, edit, ignore, or delete a global record, the corresponding localized records will also be added, edited, ignored, or deleted respectively on the In-flight Domestic Case. However, if a specific global field within a record is ignored or deleted, and the corresponding localized field is populated on the Inbox Item, then the localized data will still be carried over to the In-flight Domestic Case.

For Global type Inbox Items, when you select this action, Vault carries all global data from the Inbox Item to the In-flight Domestic Case based on your merge decisions. The Domestic Case’s Localization value does not change.

Regional fields, such as those required for the PMDA, MFDS, and NMPA, are not supported on Inbox Items.

Note: When a Follow-up Case is created from or an Inbox Item is merged into a Domestic Case for Japan, any changes made to the Case Products or Adverse Events are carried over to the Follow-up Case. The impact that these changes have on the Case Product Registrations, Localized Case Assessments, and Localized Reporting Details, such as regeneration or deletion, also takes place during Follow-up creation.

Updating Parent Information

When promoting an Inbox Item to a Follow-up Case or merging the latest data into an In-flight Case, Vault updates related Parent Information Cases when needed. For Follow-up Cases, Vault generates a new version of the Parent Information Case. For In-flight Cases, Vault merges changes into the existing Parent Information Case.

Note: Parent Information does not appear on the Case Compare page.

After completing the Case Compare page, Vault applies new and changed information from the Inbox Item and retains unchanged information from the previous or existing Parent Information Case.

If required, Vault also generates or updates Localized Case Parent Information. For details, see Manage Localized Follow-Up Cases in Prepare a Localized Case.

Merging Child Records

Vault attempts to map matching child records on the previous case version and the Inbox Item by comparing certain key fields on each record.

Note: Open label Products are matched only to open label Products, and not to unblinded Products.

If an Inbox Item child record was not matched to the previous Case correctly, you can perform one (1) of the following actions:

Select a different record from the dropdown menu on the previous Case version to match the record on the Inbox Item.
Select Create to add the Inbox Item information as a new child record on the Follow-up Case.
Select Ignore to ignore the information on this Inbox Item record and prevent it from being promoted to a Follow-up Case.

If the initial Case version contains a child record that is not present on the Inbox Item being promoted, that child record is promoted to the Follow-up Case with no changes.

Custom child records are not displayed on the Inbox Item to Case Compare page. Instead, Vault copies these records to the new Case version.

Complete the Inbox Item to Case Compare Page

Note: Some actions may not be available depending on your Admin’s configuration.

Once you finish reviewing the Inbox Item to Case Compare page, perform one of the following actions:

Mark as Duplicate: Select this option if the Inbox Item is an exact match to the Inbox Item or Case. If you select this option, Vault marks the Inbox Item as Duplicate and does not create a Case. If the matching record is a Case, Vault links the duplicate record to the matching Case’s Initial Case field. If the matching record is an Inbox Item, Vault links the original Inbox Item to the Linked Inbox Item field on the duplicate Inbox Item.
New Case - Copy Patient Information: If the current Inbox Item includes a patient with an existing Case, select this icon. If you select this option, a New Case - Copy Patient Information dialog appears. This dialog allows you to specify other information to copy in addition to creating a Case that includes the patient details.
See Copy Patient Information from Existing Case for more information.

Note: The new Case is not linked to the original Case. However, the audit trail records which information was copied.

Mark as Follow-Up: Select this option to link the Inbox Item to an In-flight Case and indicate it should be merged with the Case. In order for the action to be successful, the Case must not have completed processing and cannot be in a prohibited state.

If you select this option, the state changes to Marked as Follow-up and a new section, Inbox Item has been marked as a follow-up, appears on the Inbox Item with a link to the associated Case. Your Admin must configure the Inbox Item layout in order for this section to appear. This lets the Case Processor know there is new information on the Inbox Item that should be merged with the In-flight Case.

If you do not see this option, your Admin must enable the Mark as Follow-Up option in the Case Promotion settings.

You can undo this action by navigating back to the Inbox Item and selecting Unmark Follow-Up in the All Actions menu.

Note: Promoted Inbox Items cannot be unlinked from the Case.

Merge to Current: Select this option to merge the Inbox Item to an In-flight Case. See Merge to In-Flight Case for more information about this option.
Create Follow-Up: Select this option to merge the data from the Inbox Item with the data from the matching Case (the previous Case version) into a Follow-up Case.

Note: If you do not see the Create Follow-Up button, this may be because:

The previous Case Version is in a prohibited state.
The Inbox Item's Localization type is Global and does not match the previous Domestic Case Version.

Create New Case: Select this option to promote the Inbox Item to an initial Case version. Vault creates the Case and an Inbound Transmission record.

If you no longer want to promote this Inbox Item, you can select Back to Potential Matches to choose another Inbox Item to compare.

Consider the following:
- You cannot promote to Follow-up Case or create a new Case if Adverse Events and Products have identical names.
- You cannot promote to Follow-up Case or merge to an In-flight Case if an object on either the Inbox Item or Matching Case exceeds 10,000 records.

For more information on completing the Inbox Item to Case Compare page, use this interactive animation. This animation represents an older version of the Inbox Item to Case Compare page. Although there are some interface differences, the functionality and behavior of this page does not change so you can still interact with this animation.

Inbox Item Follow-Up Change Log

Upon creating a Follow-up Case, Vault attaches a change log to the Inbound Transmission. The change log displays the fields that were changed during the merge as well as the action taken.

For Domestic Follow-up Cases, the change log displays both global and localized fields that were changed.

If the Inbox Item did not have an Inbound Transmission, Vault creates one. You can also see the audit trail on a Case to view the changes.