Manual Inbox Item Intake

You can manually add Inbox Items to your Vault by creating new records. For information about how to process Inbox Items in non-English languages, see Perform Local Language to English Intake.

Manually Create an Inbox Item

To manually create an Inbox Item:

1. Navigate to the Inbox Items tab.
2. Select Create.
3. On the Create Inbox Item page, insert sections and populate field values as applicable.
   • If configured by your Admin, you may be able to populate a Name value. If you do this, Vault applies that value to the record. Otherwise, Vault generates the Name using the default naming format.
   • You must populate the New Info Date and Report Type fields.
   • To add child records, such as Case Contacts, Products, and Medical Events, expand the appropriate section, and then select Add. You can add multiple records to each section.
   • To open a Case for a combination product, ensure you select the applicable Combination Product type of Case Product. Do not select a Product Constituent type of Case Product.
4. When you have entered all appropriate data, select Save. Vault saves all your entered data information at once, so you do not need to save each record individually.

When you save the record, Vault validates the data in each section and notifies you if there are any errors. If there are no errors, Vault creates the Inbox Item, which you can access on the Inbox tab. If you create an Inbox Item without any data, Vault automatically adds the following sections for data entry:

• Case Contact for the primary reporter, assigned rank 1 with the Contact is also Reporter checkbox selected.
• Product for the primary suspect product assigned rank 1 with the suspect Drug Role selected.
• Medical Event for the primary adverse event assigned rank 1 with the Type of Adverse Event.

Promote an Inbox Item

When appropriate, you can promote the Inbox Item to a Case. Depending on your Admin’s configuration, Vault may automatically promote the Inbox Item.

Combination Products

When you promote an Inbox Item for a Combination Product type of Product, Vault separates the Combination Product and adds each of its Product Constituents as a Case Product. On the generated Case, Vault does the following:

• Maps Product Registrations for the Product Constituents to the Case.
  • In the Combination Product Registration field of each Case Product, Vault links the Product Registration for the Combination Product. Vault does not populate the Product Registration field.
• For each Product Constituent:
  • Maps the Product Type and Name from each Product Constituent to the Product Type and Product (Coded) fields of the Case Product Registration.
  • For Device-type Product Constituents, Vault maps the Product Code from the Product Registration for the Combination Product.
  • Maps Indications from the Inbox Item to each Case Product.
  • Maps Dosages from the Inbox Item to each non-Device-type Case Product.

Primary Case Product Designation for Combination Products

Upon Case promotion, Vault designates the primary Case Product, using the following logic:

• If there is a Product Constituent set as the PMOA on the Product Registration, Vault designates that product as the primary Case Product.
• If there are no PMOA Product Constituents, the Case Product generated first becomes the primary.

Vault populates the PMOA field on the Combination Product Registration to indicate the Product Constituents are Primary Mode of Action (PMOA). Vault also attaches a Case Assessment to the applicable Case Product. For E2B-imported Inbox Items containing Combination Products with attached Case Assessments, Vault copies the imported Case Assessments to the Product Constituents.

Enter Combination Product-Related Case Data

Vault supports combination products and device constituents, including device-specific products. You can classify the device report type (malfunction, public health risk, or both) and add additional combination product-related information for the reason a follow-up Case was created. When you select Combination Product Registration for a Case Product Constituent, Vault copies all of the registration details to the Case.

You can enter data for combination products with device constituents in the following Case sections:

• The Device Details section on the Case.
• The Device Information section on the Case Product.

Manually Create an Inbox Item from a Source Document

In Vaults using Veeva AI for Safety, Vault may automatically generate an Inbox Item for each Case > Source > Adverse Event Report classified document uploaded to your Library. Alternatively, you can manually import data from a structured E2B or non-E2B file. To intake data from unstructured and semi-structured source documents, we recommend using the Document Intake Highlighter.

Manual Intake from Emails

You can receive emails directly in your Vault and generate Inbox Items from an email source for manual intake. When configured by your Admin, your Vault automatically imports E2B data from email attachments.