Perform Inbox Item to Case Compare

Use the Inbox Item to Case Compare page to compare data on Inbox Items with data on matching previous Case versions. This is useful when merging follow-up information on Inbox Items to in-flight Cases or follow-up Cases. Select Compare Details on the Potential Matches page to open the Inbox Item to Case Compare page.

The Inbox Item to Case Compare page displays data in the following sections:

• Summary: This section 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: This section displays data from Inbox Items. Vault highlights cells with new, modified, or missing information to visually indicate the status of the data.
• Accept Change: This column displays selectable checkboxes for each field for which you can accept a change from the Inbox Item for the matching Case.
• Matching Case: This section displays data from the previous Case version with matched child records, merged with the new data from the Inbox Item for which you are accepting changes. This previews the modified data Vault will populate on the updated in-flight or follow-up Case. Vault highlights cells based on the changes you accept.

In Vaults with strict Case locking enabled, navigating to the Inbox Item to Case Compare page locks the Case. If another user has locked the matching Case who updates the Case while you are on the page, it will not reflect the latest Case data until you refresh it. When you complete the page, Vault may display a warning message to indicate the user who locked the Case may still be making changes to it.

Prerequisites

To use this feature, your Admin must enable the page. Depending on your business processes, your Admin may also complete the following:

• Configure the Inbox Item Follow-up Case Compare layout to specify which fields display on the page.
• To display the Inbox Item has been marked as a follow-up section when you run the Mark as Follow-Up action, enable the Allow Mark Follow-up setting and configure the Inbox Item layout.
• To create a domestic Case upon follow-up Case promotion in certain scenarios, enable Domestic Case Processing for Agency Jurisdictions.
• To define access to certain fields on the Case or child records, configure Atomic Security.

Data Display

Vault uses colors to help visualize different types of data displayed on the page and highlights data rows to indicate whether the related data is new, modified, or missing. You can apply filters to change the data displayed on the page, which share the color of related row data. Cells in the Matching Case section update to the applicable color as you accept changes:

• Blue: Indicates data rows with new and modified information. The New and Modified filter buttons are blue when selected. Vault also displays a blue dot () icon beside New information in Matching Case data rows.
• Orange: When you select the Missing filter, indicates data rows with missing information on the Inbox Item.

The Inbox Item to Case Compare page displays data using the following conventions and behaviors:

• 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 page displays up to ten records and up to 500 paginated records.
  • Vault displays the total number of records in the left section and promotes all records using the default merge behavior.
  • If a section includes more than ten records, you can use the pagination arrows to navigate through the pages of records.
• If the content of a field exceeds 150 characters, Vault truncates the text. You can select Show more to see the full text in a dialog. In the dialog, you can select the checkbox to accept the change and the Close button when you’re done reviewing.
• Select caret icons in any section header to expand () or minimize () that section.
• Hover over an information () icon to display relevant details in a tooltip.
• For Vaults configured to isolate blinded clinical trial information, see Isolate Blinded Clinical Trial Information for details about how the page displays blinded and unblinded records.

Tags

The Inbox Item to Case Compare page displays the following tags to indicate different types of data:

• New (): New information from the Inbox Item that doesn’t exist on the previous Case version.
• Unmatched (): Multiple field values conflict with existing record data. The tag includes the number of unmatched records available for selection. You can manually match these records or create a new record on the Case.
• Delete (): Appears when you delete field information for the follow-up Case.
• Reason Omitted (): The field value is Reason Omitted. Vault does not promote these field values over fields with existing data.
• Hidden (): You do not have permission to view the hidden data.
• Calculated (): A calculated field value based on other field values.
• Combination (): Combination Product details in a section header or row.
• Constituent (): A Combination Product constituent.
• Unknown Formulation (): A Product with an unknown formulation.
• Study (): Vault calculated study-related information.
• LLT (): The level of the MedDRA hierarchy for MedDRA-coded terms.

Filters

When you open the Inbox Item to Case Compare page, the selected filter buttons at the top indicate which information displays. When you change filter selections, Vault displays a message confirming when all sections are loaded. Clear all filter selections to display all available field data. Select and unselect the following filter buttons to update the information displayed on the page:

• 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 and grandchild records.
• Other: Displays data that is unchanged between the Inbox Item and previous Case version and empty rows for fields that are blank on either record.

Non-Filterable Fields

The Inbox Item to Case Compare page always displays certain fields to serve as key identifiers of each record so you can confirm accurate matches. Vault displays the following non-filterable Case-related fields regardless of your filters:

• Details
  • Receipt Date
  • New Info Date
  • Report Type
• Contacts
  • Qualification
  • First Name
  • Last Name
• Patient
  • Patient Name Prefix
  • Patient First Name
  • Patient Last Name
  • Gender
  • Date of Birth
  • Date of Death
• Products
  • Primary
  • Drug Role
  • Product (Coded)
  • Name
  • Product (Reported)
  • Registration Number
  • Study Arm Product
  • Blinded Name (Placeholder)
• Dosages
  • Dose (number)
  • Dose (unit)
  • Frequency (number)
  • Frequency (unit)
  • First Administration
  • Last Administration
• Indications
  • Name (MedDRA)
• Substances
  • Substance Name
• Adverse Event
  • Event (Reported)
  • Event (LLT)
  • Event Country
  • Onset (normalized)
  • Cessation (normalized)
  • Seriousness
• Diagnoses
  • Name (Reported)
  • Name (MedDRA)
• Medical Assessments
  • Case Assessments
    • Product
    • Product Name
    • Event (LLT)
    • Event (LLT) - MedDRA
  • Case Assessment Results
    • Source Type
    • Source (text)
    • Source
• Causes of Death
  • Cause of Death (LLT)
  • Cause of Death (Reported)
• Medical History & Concurrent Conditions
  • Condition / Procedure
  • Condition / Procedure (LLT)
• Drug History
  • Drug Name (Reported)
  • Drug (Coded)
• Test Results
  • Test Name (Reported)
  • Test Name (LLT)
• Study
  • Study Name
  • Study Number (Reported)
• Study Registrations
  • Registration Number
• Linked Cases
  • Related Case Identifier
• Reference Numbers
  • Case Identifier

Review and Accept Changes

The Accept Change column has checkboxes for each row with data changes. Use these checkboxes to specify the values Vault will populate on the new Case version:

• Select the applicable checkboxes to display a checkmark (), indicating that you accept the incoming data from the Inbox Item for the selected field.
  • You cannot select the checkbox for the Narrative Preview field for narratives generated from templates.
  • You may not have access to certain fields on the Case or child records due to your Admin’s configuration (for example, on unblinded Cases). For fields you do not have permission to view, Vault hides this information and displays Hidden tags instead of the field values. You cannot select checkboxes for hidden fields you do not have permission to view. Vault uses the default behavior depending on the type of change. If applicable, another user with greater permissions can promote to follow-up so you can modify these fields.
• Clear any checkboxes to retain the value on the matching Case.
  • When field data is missing on the Inbox Item but is present on the previous Case version, Vault clears the checkbox to promote the field with data from the previous Case version.
  • If you clear a checkbox for a calculated () field, Vault does not promote the auto-calculation value.
• Select which child records to promote.
  • To accept all of the new data within a child record, select the checkbox in the header of the table and if applicable, clear checkboxes for rows you want to exclude from the new Case version.
• When you select the 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.

After making your selections, the field in the Matching Case section displays the value Vault will apply when you complete the page. If you leave the page without completing the page, Vault does not save any changes you accepted.

Accept Combination Product Changes

Consider the following when working with Combination Products on the Inbox Item to Case Compare page:

• When you select Ignore All on a Combination Product or Case Combination Product, the Accept Change checkbox remains selected.
• The Accept Change checkbox for Combination Product Registrations inherit the Combination Product field setting.

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. 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 do one of the following:

• Select a different record from the drop-down list on the previous Case version to manually 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 and prevent it from being promoted.
• If configured by your Admin for the associated data source, select Ignore All to ignore all new information on the record. This preserves any clean-up Case Processors have already performed on initial Cases to ensure the data is accurate for submissions and reporting. You can then selectively choose which new changes to accept by selecting the applicable Undo Ignore buttons.
  • When you select Ignore All, Vault never ignores certain fields, including the following:
    • Case-level fields without selectable checkboxes
    • ID and global ID fields
    • Link
    • MedDRA Version
    • New Info Date
    • Receipt Date
    • Session Store ID

If the initial Case version contains a child record that is not present on the Inbox Item you are promoting, Vault promotes that child record to the follow-up Case with no changes.

Matched Records

Vault references the following field values to identify matches to existing related records. If Vault finds multiple potential matches based on the following match fields, it references tie-breaker fields on certain records to identify the best possible match:

Related Case Object	Match Fields	Tie-Breaker Fields
Case Adverse Event	Event (Reported) Event (LLT) PT Code of the specified Event (Reported)	Onset (normalized) Cessation (normalized) Seriousness
Case Product 1 (matches must be of the same object type and Blinding Type)	Registration Number Name Product (Reported) MPID Serial Number Lot Number Blinded Name (Placeholder)	Drug Role
Case Product Dosage	Dose (number) Frequency (number) Batch/Lot Number	Dose (unit) Frequency (unit) First Administration Last Administration Dose Form Patient RoA
Case Product Substance	Substance Name TermID	Strength (Number) Strength (Unit)
Case Product Indication	Name (MedDRA) Name (Reported) PT Code of the specified Event (Reported)
Case Contact 2 (matches must be of the same object type)	Last Name First Name Email Address Telephone Qualification	Organization
Case Assessment Result	Source Source (text) Source Type
Case Relationship	Related Case Identifier 3
Case Study Registration	Registration Number Country
Case Test Result	Test Name (LLT) Test Name (Reported) PT Code of the specified Event (Reported)	Date
Case Identifier 3	Case Identifier 3
Case Cause of Death	Cause of Death (LLT) Cause of Death (Reported) PT Code of the specified Event (Reported)
Case Diagnosis	Name (MedDRA) PT Code of the specified Event (Reported)
Case Drug History	Drug (Coded) Drug (Reported) MPID	Start Date End Date
Case Medical History	Condition / Procedure (LLT) Condition / Procedure (Reported) PT Code of the specified Event (Reported)	Start Date End Date Normalized
1. When matching a Case Product: For blinded Case Products, Vault attempts to match based on the Study Product Placeholder. If the Study Product Placeholder is blank, Vault attempts to match based on the Product (Reported) value. When matching an unknown formulation Case Product, Vault considers all Products within the Product Family as potential matches. When matching combination products, Vault includes additional matching criteria.
2. When the Inbox Item and matched Case both have a single Case Contact, Vault considers it a match unless multiple populated Case Contact match field values conflict.
3. 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.

Manually Match

When Vault finds similar records but no exact match, you can manually match it by selecting the applicable record from the drop-down for the unmatched section. The drop-down includes an alphabetized list of selectable records that are not already matched to the Inbox Item to review for manual match, followed by a list of other records for your reference that are already matched to the Inbox Item. Some records in the drop-down selector include details in parentheses to indicate why it’s not an exact match (for example, a type mismatch). If you do not manually match an unmatched record, Vault creates a new record on the Case.

Combination Products

For combination products, Vault attempts to match Products on the Inbox Item to Case Compare page using the following priority:

1. Those with the same Combination Product on the Case Combination Product record.
2. Those with the same Combination Product on the Case Product.

For non-matching Combination Products with Products that share the same Product Family, Vault attempts to match constituent Products that are common to both Combination Products. Vault never matches constituent Products to Case Products with no Combination Product value. For any constituent Products that Vault cannot match to a common Combination Product, Vault retains the Case Product on the updated Case. You can manage and recode combination Case Products using the Case Combination Product record.

Complete the Inbox Item to Case Compare Page

When you finish reviewing the Inbox Item to Case Compare page and accepting changes, run one of the following actions:

• Mark as Duplicate (): Select this action if the Inbox Item is an exact match to the Inbox Item or Case. Vault updates 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 Initial Case field of the matching Case. 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 (): Select this action if the current Inbox Item includes a patient with an existing Case. In the New Case - Copy Patient Information dialog, you can specify other data to copy in addition to creating a Case that includes the patient details. Vault does not link the new Case to the original Case. However, the audit trail includes details about the copied data. To run this action, ensure the following:
  • Adverse Events and Products must not have identical names.
  • The Inbox Item must not be in Marked as Follow-up state (you can navigate back to the Inbox Item and run the Unmark Follow-Up action).
  • For Inbox Items generated by the Safety-EDC Connection, no existing Cases have an identical Link value.
• Mark as Follow-Up (): Select this action to link the Inbox Item to an in-flight Case and indicate it should be merged with the Case. Vault updates the state to Marked as Follow-up and the Inbox Item has been marked as a follow-up section appears on the Inbox Item with a link to the associated Case, which alerts the Case Processor about new information to merge to the in-flight Case. To run this action, ensure the following:
  • The Case must have completed processing and cannot be in an Admin-defined prohibited state, or in Void, Nullified, Voiding, or Nullifying state (or any state in the Deleted state type).
  • Adverse Events and Products must not have identical names.
  • No sections on the page can exceed 10,000 matching records.
• Merge to Current (): Select this action to merge the Inbox Item to an in-flight Case. To run this action, ensure the following:
  • The Case must not be in Void, Nullified, Voiding, or Nullifying state (or any state in the Deleted state type).
  • For non-PMDA domestic Inbox Items, the Case must not be a PMDA domestic Case.
  • No sections on the page can exceed 10,000 matching records.
• Create Follow-Up: Select this action to merge the data from the Inbox Item with the data from the matching Case (the previous Case version) into a follow-up Case.
  • To run this action for non-PMDA domestic Inbox Items, the Case must not be a PMDA domestic Case.
• Create New Case: Select this action to promote the Inbox Item to an initial Case version. Vault creates the Case and an Inbound Transmission. If you no longer want to promote this Inbox Item, select Back to Potential Matches to choose another Inbox Item to compare. To run this action, ensure the following:
  • Adverse Events and Products must not have identical names.
  • The Inbox Item must not be in Marked as Follow-up state (you can navigate back to the Inbox Item and run the Unmark Follow-Up action).
  • For Inbox Items generated by the Safety-EDC Connection, no existing Cases have an identical Link value.

Log File

After your selected action completes, Vault generates a CSV log file detailing the potential matches results, which you can access from the Attachments section of the associated Inbound Transmission.

Promote and Merge Inbox Item Data

The following sections describe how Vault promotes and merges Inbox Item data to Cases. For more information about how Vault promotes and merges data, see Promote to Case.

Significance

When you promote an Inbox Item to a Case or merge the latest data to an in-flight Case, Vault populates the Significance value of the Case based on the Inbox Item’s specified value. The following mapping ensures that when you merge data to an in-flight Case, Vault prevents downgrading the Significance value on the existing Case:

Inbox Item	Promoted to Case	Merged to In-Flight Case
Initial Case	Significant	N/A
Non-Significant Follow Up	Non-Significant	Retains existing value
Significant Follow Up	Significant	Significant
Urgent-Significant Follow Up	Significant	Significant

Updating Parent Information

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 record. If applicable, Vault also generates or updates Localized Case 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 when applicable. For follow-up Cases, Vault generates a new version of the Parent Information. For in-flight Cases, Vault merges changes into the existing Parent Information.

Localized Data

When promoting a local Inbox Item to a domestic follow-up Case, Vault copies all global and localized data along with all related child records to the new or follow-up Case. When promoting a Global type Inbox Item (the Localization field value is blank or Global) to a domestic follow-up Case, Vault copies all global data with all related child records to the new or follow-up Case. This includes Localized Case fields not displayed on the page, even if you select Ignore for the global record. When you run an action to complete the page, Vault copies and merges localized data depending on the type of Inbox Item:

• Create New Case
  • Local: Vault copies all localized data to the generated initial Case version.
  • Global: Vault copies all global data to the generated initial Case version.
• Create Follow-Up
  • Local: Vault merges all localized data from the Inbox Item and previous Case version and copies it 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 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 copied to the new follow-up Case.
  • Global: Vault merges all global data from the Inbox Item and localized data from the previous Case version and copies it to a new domestic follow-up Case. Vault sets the follow-up Case’s Localization value using the previous Case’s localization (Local).
• Merge to Current
  • Local: Vault copies all localized data from the Inbox Item to the in-flight domestic Case based on your merge decisions on the page. If you add, edit, ignore, or delete a global record, Vault makes the same updates to the corresponding localized records 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 is copied to the in-flight domestic Case.
  • Global: Vault copies 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.

Limitations

The Inbox Item to Case Compare page has the following limitations:

• 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.
• Each section displays up to 500 paginated records. Although the page does not display more than 500 records in any section, Vault displays the number of records in the left section and promotes those records using the default merge behavior.