Inbox Item Overview

Learn about using Inbox Items for the Safety Intake process.

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.

Create Inbox Items

You can manually create Inbox Items and generate Inbox Items from the following sources:

• E2B transmissions
• Emails and email attachments
• Imported files
  • JSON files through the Vault API
• Library documents
• Connections
  • Medical-Safety Connection
  • Quality-Safety Connection
  • Safety-EDC Connection

Vault populates generated Inbox Items with field values based on the source data.

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. You can save custom views to return to your view settings.

• Sort: Select 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.
  • 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.
• Filter: Select 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.

Inbox Item Audit Trail

You can view an audit trail to see the full history of all workflow tasks performed on an Inbox Item. Audit trails include details about the following:

• Inbox Item creation
• Create Case action runs
• User updates any Inbox Item section, including:
  • Edit
  • Save
  • Delete
  • Undo (undelete)

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. Some of the default Inbox Item lifecycle states include:

• 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.

Seriousness and Priority Calculation

Cases should be processed in a timely manner based on their priority. When there is a high volume of Cases, it is crucial to determine Case priority quickly. Vault calculates Seriousness and Priority based on the Inbox Item’s top-ranked adverse event according to the following order, which you can edit as needed:

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]1	P3	7
1. Vault assigns P3 priority to Inbox Items without seriousness criteria and at least one associated adverse event.

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.

Import Suggestions

For imported Inbox Items, Vault generates suggestions to assist with processing and verification. Vault identifies suggestions with a lightbulb icon, along with a confidence calculation and rationale, which you can edit as needed. Vault generates the following suggestions:

• Priority
• Drug Role and Rank for Products
• Event Country for Medical Events

Product Rank Auto-Calculation

Vault auto-calculates and suggests Product rank for imported Inbox Items based on the following:

• Rank 1: Assigned to the first imported Product with a Drug Role of Suspect, Interacting, or Drug Not Administered that matches to a product. If there is no Suspect drug, Vault assigns this rank to the first imported Product with a matching product. Vault assigns this rank to a single record and checks for a product match in the following sequential order:
  1. Study Product
  2. Study Product Placeholder
  3. Company Product
• Rank 2: Assigned to all other Products with matching Study Products, Study Product Placeholders, or Company Products.
• Rank 3: Assigned to all other Products.