You can review Inbox Item data against previous Case versions and decide how to merge the information into in-flight and 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 the Inbox Item to Case Compare Page
The Inbox Item to Case Compare page supports comparing data on Inbox Items to data on previous Case versions. This is useful when merging follow-up information on Inbox Items to in-flight Cases or follow-up Cases. In either scenario, you access the Inbox Item to Case Compare page by selecting the Compare Details button on the Potential Matches page.
Note: Optional: Your Admin can configure the Inbox Item Follow-up Case Compare layout to choose which fields are available for merging to follow-up.
Prerequisite
To use this feature, your Admin must enable Inbox Item Follow-Up Case Compare.
Inbox Item to Case Compare Page Overview
The following image represents the Inbox Item to Case Compare page:
The Inbox Item to Case Compare page is divided into sections:
- Summary: The left sidebar lists the visible Inbox Item and Case sections based on filter selections. For each section, the summary indicates the number of new, modified, and missing data elements, if any. Select a section in the summary to navigate to the related records.
- Inbox Item [Inbox Item ID]: The middle section displays data from Inbox Items. Cells with new, modified, or missing information are always highlighted to visually indicate the status of the data.
- Matching Case [Case ID]: The section on the right displays data from the previous Case version merged with the new data from the Inbox Item. This previews the modified information that will form the updated in-flight or follow-up Case. Cells include visual indicators based on your selections.
Note: If you leave this page, Vault does not save any changes you made.
Data Display
Vault displays records from each section on the Inbox Item or matched Case, depending on filter selections. Within each section, if a parent record includes child records, Vault displays each child record as a separate nested table within the table for the parent record.
Each section on the Inbox Item to Case Compare page displays up to ten (10) records at once. If a section includes more than ten (10) records, you can use the pagination arrows to navigate through the pages of records.
If 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.
If the content of a field exceeds 150 characters, Vault truncates the text and includes a Show more link. When you select Show more, a dialog opens that includes the full text from both the Inbox Item and the Case, as applicable. From this dialog, you can select the Accept Changes checkbox to apply the Inbox Item text to the updated Case version. Select the Close button to return to the Inbox Item to Case Compare page.
Filters
When you open the Inbox Item to Case Compare page, the selected filter buttons at the top indicate which information appears. Adjust filter selections to update the information you see:
- New: Displays data on the Inbox Item that is not on the previous Case version, including any new Case child records.
- Modified: Displays data that has changed between the previous Case version and the Inbox Item, including any modified Case child records.
- Missing: Displays data from the previous Case version that is not present on the Inbox Item, including any Case child records.
- Other: Displays data that is unchanged between the Inbox Item and previous Case version and empty rows for fields that are blank on both the Inbox Item and previous Case version.
Inbox Items and Cases with large amounts of data may take longer to load. When you change filter selections, Vault confirms the display is ready with the message All sections loaded
, which appears to the right of the filters. Clear all filter selections to display all Inbox Item to Case Compare field data.
Visual Indicators
Inbox Item data rows are always color-coded to indicate whether the related data is new, modified, or missing. Matching Case data rows are color-coded when the data is being applied to the in-flight or follow-up Case. Filter buttons share the color of related row data. Color-coding includes:
- Blue: Indicates new and modified data rows. The New and Modified filter buttons become blue when selected.
- In addition to highlighting these rows in blue, Vault includes a blue dot beside New information in the Matching Case data rows.
- Orange: Indicates data rows with missing information on the Inbox Item. The Missing filter button becomes orange when selected.
The exception is the Other filter button, which becomes grey when selected but relates to white Inbox Item and Matching Case data rows.
Tags
The following table outlines tags you may see on the Inbox Item to Case Compare page:
Icon | Description |
---|---|
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Indicates new information from the Inbox Item that doesn't exist on the previous Case version. |
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Appears when you delete field information for the follow-up Case. |
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Indicates the field was set to Reason Omitted. |
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Indicates Vault automatically calculated a field using information entered in other fields. |
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For MedDRA-coded terms, indicates the level of the MedDRA hierarchy. |
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In the section header, indicates a Combination Product record. At the row level, indicates that Vault calculated Combination Product-related information. |
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Indicates Vault automatically calculated study-related information. |
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Data displayed as bullets indicates you do not have access to these fields on the Case or child records due to atomic security. |
Isolate Blinded Clinical Trial Information
For Vaults configured to isolate blinded clinical trial information, learn how the Inbox Item to Case Compare page displays blinded and unblinded records.
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.
To accept all of the new data within a child record, select the Accept Change checkbox in the header of the related table. After selecting the Accept Change checkbox at the header level, you can clear the checkbox on specific rows with data you want to exclude from the new Case version. To accept missing data within a parent or child record, you must select the Accept Change checkbox on each row.
When you select the Accept Change checkbox on a row with missing data on the Inbox Item, Vault strikes out the text in the Matched Case column to indicate the information will be removed on the new Case version.
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: There is a known limitation 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 limitation 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.
How Vault Promotes and Merges Inbox Item Data
The following sections provide information on how Vault promotes and merges Inbox Item data to create 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 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 Vault 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 ,
, or
tag. These fields include information related to Combination Products and Studies.
Before merging the Inbox Item to a follow-up Case, you can override the default behavior by clearing the checkbox to prevent the following Vault calculations from promoting to Case:
- An inbound Transmission
- A Case Unique Number
- Case Assessments and Case Assessment Results
- Auto-expectedness and Case Assessment Expectedness
- 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
- Listedness
- Relatedness
- Assessment Tag
- Watchlist Tags
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 Localization field on the Inbox Item 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 (the Localization field value 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 Vault 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.
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 on 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 Localization value of the domestic Case 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 Inbox Item to Case Compare page.
After completing the Inbox Item to 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 Prepare a Localized Case.
Promote 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 you select Ignore or Delete on a parent record, Vault also ignores or deletes all related child records. To accept the changes from a child record, you must first select Undo Ignore or Undo Delete on the parent record.
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 drop-down list on the previous Case version to match to 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. In some scenarios, Vault prevents running certain actions.
Once you finish reviewing the Inbox Item to Case Compare page, perform one (1) 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, the 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. For more information, see Copy Patient Information from Existing Case.
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.
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 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.
-
Merge to Current: Select this option to merge the Inbox Item to an in-flight Case. For more information, see Merge to In-Flight Case.
- 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.
- 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.
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.
Considerations
In certain scenarios, Vault prevents running Inbox Item to Case Compare page actions:
- 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.
- From Inbox Items in the Marked as Follow-up state, you cannot create a new Case. In this scenario, Vault prevents running the Create New Case and New Case - Copy Patient Information actions. To complete either action, navigate back to the Inbox Item and select Unmark Follow-Up from the All Actions menu.
- To mark an Inbox Item as a follow-up, the Case must not have completed processing and cannot be in a prohibited state.