You can create Inbox Items manually.
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 Manual Inbox Items
You can manually add Inbox Items to your Vault. When you create an Inbox Item record without any data, Vault will automatically add the following empty sections for data entry:
- A Primary Reporter Case Contact record with a Rank 1 designation and the Contact is also Reporter checkbox enabled.
- A Primary Suspect Product Case Product record with a Rank 1 designation, a Case Product Type and the Suspect Drug Role selected.
- A Primary Adverse Event Medical Event record with a Rank 1 designation and an Adverse Event Type selected.
Note: You cannot copy Inbox Items.
See Perform Local Language to English Intake to process an Inbox Item in a non-English language.
Manually Create an Inbox Item
- From the primary navigation bar, select Create > Inbox Item.
- On the Create Inbox Item page, add sections and field values as required:
- Inbox Item Field Reference provides descriptions of the Inbox Item fields.
The New Info Date and Report Type fields are required. - 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 of each type.
- Inbox Item Field Reference provides descriptions of the Inbox Item fields.
- At the top of the page, select Save.
Vault saves all the Inbox Item information at once, so you do not need to save each record individually.
Result
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 appears on the Inbox tab.
Note: If a Study changes after a user manually creates and saves an Inbox Item with Case Product information, Vault clears Study Product information on the Inbox Item, including Blinded Name (Study Product Placeholder) and open-label or unblinded Study Products.
How to Open a Case for Combination Products
- Create an Inbox Item (manually or through import).
- For manual creation, select the Combination Product as the Case Product. You must select the Combination Product and not a Product Constituent to leverage the full capabilities of combination products.
- Promote the Inbox Item to a Case.
Result
On the promoted Case, Vault separates the Combination Product and adds each of its Product Constituents as a Case Product. The following occurs:
- Vault 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:
- Vault 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.
- Vault maps Indications from the Inbox Item to each Case Product.
- Vault 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.
Product Constituents are set as PMOA through the PMOA field on the Product Registration.
Once the primary Case Product is determined, Vault attaches a Case Assessment to it. For E2B-imported Inbox Items containing Combination Products with attached Case Assessments, upon Case promotion Vault copies the imported Case Assessments to the Product Constituents.
Note: When promoting an E2B-imported Inbox Item with a Combination Product to a follow-up Case, Vault does not copy the imported Case Assessments and Case Assessment Results to the follow-up Case. This known limitation will be addressed in a future release.
Enter Combination Product-Related Case Data
Vault includes data entry capabilities that support combination products and device constituents, including device-specific product fields. 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 a Combination Product Registration is selected for a Case Product Constituent, Vault copies all of the registration details to the Case.
The following list outlines the specific sections that you can use to enter data for Cases concerning combination products with device constituents:
- The Device Details section on the Case object.
- The Device Information section on the Case Product object.
Manual Inbox Item Names
If the Name field appears on the Inbox Item and you enter a value in this field, Vault uses that to name the Inbox Item. Otherwise, Vault generates the Inbox Item name using the default naming format.
Admins must configure the Inbox Item layout to display the Name field. By default, this field does not appear.
Manually Create an Inbox Item from a Source Document
The following instructions are for creating Inbox Items from non-E2B documents in Vault Safety. For E2B import instructions, see Import an Inbox Item.
- Go to the document in the Vault Library.
Adding Documents provides instructions on adding documents to the library.
The Create Inbox Item action is only available for the latest document version. The user action does not appear for older versions. - Verify that the following document fields are populated:
- Organization: (Required) Select the Organization that will process the Inbox Item and Case.
- Receipt Date: (Optional) Select the receipt date. Vault maps this field to the Inbox Item New Info Date. If you don’t specify this field, Vault sets it to the current date, by default.
- Report Type: (Optional) Select the report type. If you don’t specify this field, Vault sets the Report Type to Spontaneous on the Inbox Item by default.
Vault uses the values in these fields to automatically populate the corresponding fields on the resulting Inbox Item and Case. If you don’t see the Receipt Date or Report Type fields, contact your Admin to add these fields.
- Expand the All Actions menu, and then select Create Inbox Item.
Note: The Create Inbox Item from Document user action label may differ depending on your Admin’s configuration. If you don’t see this user action available, contact your Admin to ensure that the action has been made available.
Result
The Inbox Item has been created and links to the document as it’s source document. Once created, the document Inbox Item field links to the Inbox Item.
Case Access Groups
When an Inbox Item is generated from a source document, Vault populates the document’s Case Access Group field. This field is inherited from the associated Inbox Item and is read-only.
To view the Case Access Group for a document, go to the Document Information pane, expand the Case Information section, and check the Case Access Group field.
Note: For the Case Access Group field to appear, your Admin must enable Case Access Group Security.
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 may automatically import E2B data from email attachments. For more information, see Email to Inbox Item.