Learn about Inbox Items and the lifecycle states in the Safety Intake process.
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 Items
You can view all Inbox Items in your Vault on the Inbox tab, which displays all Inbox Items on an object record list page. From here, you can review and sort existing records in a detailed table, manually create new records, and perform intake.
Prerequisites
To support Inbox Items in your Vault, your Admin must enable Inbox Items and assign you permissions to delete data in the Products, Medical Events, and Reporter-type Case Contacts sections.
Note: These permissions do not allow you to delete Inbox Items.
Create Inbox Items
You can manually create Inbox Items and generate Inbox Items from the following sources:
Vault populates generated Inbox Items with field values based on the source data.
Seriousness & Priority Calculation
Vault calculates Seriousness and Priority based on the Inbox Item’s top-ranked adverse event according to the following order:
| Seriousness | Priority | Order |
|---|---|---|
| Results in death | P1 | 1 |
| Life threatening | P1 | 2 |
| Caused / prolonged hospitalisation | P2 | 3 |
| Disabling / incapacitating | P2 | 4 |
| Congenital anomaly / birth defect | P2 | 5 |
| Other medically important condition | P2 | 6 |
| [Blank]* | P3 | 7 |
Depending on your Admin’s configuration, Required Intervention to Prevent Permanent Impairment/Damage (Devices) may be an available Seriousness value on Cases with Devices and Combination Products. Vault excludes this value when calculating Seriousness and Priority on Inbox Items and Overall Case Seriousness on Cases. When auto-ranking Case Adverse Events, Vault considers this value to be less serious than Other medically important condition, but more serious than a blank Seriousness value.
*Vault assigns P3 priority to Inbox Items without seriousness criteria and at least one (1) associated adverse event.
When you update the Priority value without changing any other adverse event information, Vault retains the manually updated Priority value. However, if you update, add, or delete the Event, Vault recalculates the Priority upon saving the Inbox Item.
Sort and Filter the Inbox
You can sort and filter the Inbox to quickly review data and identify Inbox Items that require your immediate attention.
Note: Contact your Admin for more information about the standard fields on the Inbox Item object to better understand which fields you can search and filter by on the Inbox tab.
Sort
You can sort and filter the records on this page by any standard field on the Inbox Item object to help find and review the applicable records. For example, you can sort by the New Info Date column to view late Inbox Items or filter by Seriousness to view all Inbox Items with adverse events that resulted in death.
Click any column header to sort the records listed on the page by that option. You can customize the records grid to change the columns displayed on the Inbox page.
Filter
Click the Edit () icon in the Filters section on the left side of the page to create reusable options. You can select different options within these filters to refine your search even more. You can delete this filter option by selecting the X (
) icon in the filter’s header.
Custom Views
Custom views allow you to save or bookmark your current search results, filters, and other view settings. You can return to this view with a single click. You can create multiple custom views and return to them at any time.
Inbox Item Audit Trail
You can view an audit trail to see the full history of all workflow tasks performed on an Inbox Item.
What is Logged in Audit Trail
- When an Inbox Item is created
- When a user performs any of the following for an Inbox Item section:
- Edit
- Save
- Delete
- Undo (Undelete)
- When a user runs the Create Case action
Inbox Item States
After you create an Inbox Item, you can change the Inbox Item’s state from the All Actions or Workflow State Change (
) menu. The following table summarizes some of the default Inbox Item lifecycle states:
- New: Inbox Item is not yet promoted to a Case.
- Import Error: Inbox Item import has failed. The user who initiated the import can view the error message in the import notification.
- Rejected: Inbox Item rejected during intake. In this state, the Inbox Item is closed to prevent further processing or Case promotion.
- Marked as Follow-Up: Inbox Item is associated with a Case but is not included in that version. You can merge it into the active version or promote it to a new version.
- Marked as Follow-Up (Not Current): Inbox Item generated by the Safety-EDC Connection is associated with a Case that is also associated with a more recent Inbox Item.
- Superseded: Inbox Item generated by the Safety-EDC Connection is associated with a Case that is also associated with a more recent Inbox Item with a higher-priority Significance value, which Vault promoted instead of the superseded Inbox Item.
- Verification: Inbox Item is ready for verification.
- Processing: Inbox Item is in the process of being automatically promoted to an initial or follow-up Case.
- Missing Information: Inbox Item is missing information and cannot be promoted to a Case.
- Duplicate: Inbox Item detected as a duplicate prior to Case promotion. In this state, the Inbox Item is closed to prevent further processing or Case promotion.
- Promoted: Inbox Item successfully promoted to a Case.
- Promotion Failed: Inbox Item failed automated Case promotion due to not meeting the conditions for being marked as a follow-up Case or created as a follow-up Case.