Note: If you leave the page without completing any actions, Vault does not save any changes you made.
) icon to display relevant details in a tooltip.
* For records generated by the Safety-EDC Connection, this may include details about product type mismatches for records with identical _Link_ values.
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.
) 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_.
#### Tags {#tags}
The _Inbox Item to Case Compare_ page displays the following tags to indicate different types of data:
* **New** (
): Indicates new information from the _Inbox Item_ that doesn't exist on the previous _Case_ version.
* **Unmatched** (
): Indicates 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**][4] (
): Indicates the field value is _Reason Omitted_.
* [**Hidden**][5] (
): Indicates you do not have permission to view the hidden data.
* [**Calculated**][6] (
): Indicates Vault calculated a field using information entered in other fields.
* [**Combination**][6] (
): Indicates _Combination Product_ details in a section header or row.
* **Constituent** (
): Indicates a _Combination Product_ constituent.
* **Unknown Formulation** (
): If your Vault uses unknown formulation products, indicates a _Product_ with an unknown formulation.
* [**Study**][6] (
): Indicates Vault calculated study-related information.
* **LLT** (
): Indicates the level of the MedDRA hierarchy for MedDRA-coded terms.
### Isolate Blinded Clinical Trial Information
For Vaults configured to isolate blinded clinical trial information, see Isolate Blinded Clinical Trial Information for details about how the _Inbox Item to Case Compare_ page displays blinded and unblinded records.
### Matched Cases {#matching}
Vault references the following field values to identify matches to existing _Cases_. 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 |
|
|
| Case Product 1, 3
(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 |
|
|
| Case Cause of Death |
|
|
| Case Diagnosis |
|
|
| Case Drug History |
|
|
| Case Medical History |
|
|
| 1. When matching a blinded Case Product, 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. | ||
| 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 matching an unknown formulation Case Product, Vault considers all Products within the Product Family as potential matches. | ||
Note: You cannot select the Accept Changes checkbox for the Narrative Preview field for narratives generated from templates.
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.
| 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 |
Note: The Inbox Item to Case Compare page does not display custom child records. Instead, Vault copies these records to the new Case version.
## 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 lets the Case Processor know 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_.
### 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 needed. 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: Parent information does not appear on the Inbox Item to Case Compare page.
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.