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][14], 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][3], enable Domestic Case Processing for Agency Jurisdictions.
* To define access to certain fields on the _Case_ or child records, configure Atomic Security.
## Data Display {#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][7] 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][10]:
* **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_][7] 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][7]. Within each section, if a parent record includes [child records][9], 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][1].
* 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][10] 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.
Note: Depending on your Admin’s configuration, the page may not display certain fields. However, Vault will map the undisplayed source information to the Case. After merging or promotion, you can review any hidden source information in the log file.
): 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][13] 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 {#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 {#non-filter}
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 {#accept}
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][11] 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][9].
* To accept all of the new data within a [child record][9], 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][14]. 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 {#promote}
Vault attempts to map matching child records on the previous _Case_ version and the _Inbox Item_ by comparing certain [key fields][12] 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][13] 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.
Note: The Inbox Item to Case Compare page does not display custom child records. Instead, Vault copies these records to the new Case version.
| Related Case Object | Match Fields | Tie-Breaker Fields |
|---|---|---|
| Case Adverse Event |
|
|
| Case Product 1
(matches must be of the same object type and Blinding Type) |
|
|
| Case Product Dosage |
|
|
| Case Product Substance |
|
|
| Case Product Indication |
|
|
| Case Contact 2
(matches must be of the same object type) |
|
|
| Case Assessment Result |
|
|
| Case Relationship |
|
|
| Case Study Registration |
|
|
| Case Test Result |
|
|
| Case Identifier 3 |
|
|
| Case Cause of Death |
|
|
| Case Diagnosis |
|
|
| Case Drug History |
|
|
| Case Medical History |
|
|
1. When matching a Case Product:
| ||
| 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. | ||
### Combination Products {#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 {#complete}
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 {#log}
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 {#promote-merge}
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 {#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 {#update-parent-info}
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_.
Note: The Inbox Item to Case Compare page does not display parent information.
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 copied 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.