Inbox Item Field Reference

Select the Study associated with the report. For deprecated Studies, a DEPRECATED tag displays.

Upon promotion, with the exception of generated Inbox Items containing a Study with unspecified products, Vault maps details from the Study to populate details from this Study on the Case, including the Study Registration, Products, Dosage, and Indication. Upon promoting a generated Inbox Item containing a Study with unspecified products, the imported Study Name and Number are used instead of those from the Study library.

Select the Study Arm associated with the suspect Product, if applicable. You cannot edit this field if you selected a Study with unspecified products (a Study placeholder) or Inbox Items generated from an imported E2B file.

Upon promotion, Vault maps details from the specified Study to populate details from this Study Arm on the Case, including the Products, Dosage, and Indication. For blinded Study Arms, Vault creates placeholder Case Products using the Blinded Name. For open arms, Vault maps the Study Products to the Case.

• Case Identifier: Enter a reference number.
• Type: Select the type. Selecting E2B Re-Transmittable will include the Case Identifier and Source fields on the E2B transmission document upon E2B export. Selecting Non-Transmittable will not include them.
• Source: Enter source details. If you selected E2B Re-Transmittable for Type, you must enter a value.

Select the appropriate locale in which the source report was received to allow dual language data entry (local to English). Depending on your Admin's configuration, Vault may populate this field based on reporter locale. When Vault populates this field, it may not display a value until you click into the field value or save the Inbox Item.

Upon promotion, Vault processes the Case as domestic or global based on the Localization Type of the specified Localization.

Enter the state or province where the contact resides. For primary Reporter types of contacts on domestic cases, if a specified Country has associated Country State/Province mapping domestic state codes, you can select a value from the drop-down. If no records exist, enter a value. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

If the specified Country has mapped domestic state codes, but the specified State/Province does not match any mapped value, an INVALID tag displays.

Enter a numeric value to order products by rank. For imported Inbox Items, Vault may populate this field with a suggested rank.

The Case Product ranked as 1 identifies the primary Product. When you save the Inbox Item, ranked products display in ascending order.

Select the characterization of the drug role in the adverse event as provided by the primary reporter or sender. For imported Inbox Items, Vault may populate this field with a suggested role. For Case Product types of Products, if the Study Arm field contains a value, Vault populates this field with Concomitant, which you cannot modify.

For FDA MedWatch 3500A reports to include device types, you must select Interacting, Suspect, or Drug Not Administered.

Vault populates this field with the suspected company product associated with the adverse event based on the value in the Product or Study Product field, as applicable.

For deprecated Products and Product Registrations, a DEPRECATED tag displays.

Select the Study Product.If the specified Study is blinded, select the masking state (Blinded, Open Label, or Unblinded) from the first drop-down, and then select the Study Product or the Blinded Name (Study Product Placeholder) from the second drop-down.

This field displays if you specified a Study, but does not display for manually created Inbox Items with armed Studies.

Select the appropriate radio button and specify how often the dose was administered:

• Every: Enter a numeric value and then select the applicable interval from the drop-down.
• times per: Enter a numeric value and then select the applicable interval from the drop-down.
• Other: Select the applicable value from the drop-down to indicate the dosage regimen is not specific to a time interval, the exact frequency is unknown, or if only total product dosage is known. For example, if a patient took 100mg of a drug in total, enter 100mg in the Dose field and select Total from this drop-down.

After saving the Inbox Item, Vault displays an E2B-compliant description of the values. For example, "4 times per day (.25 days)".

1. For Inbox Items generated from an email, the Pre-Populate Country value of the sender's associated Transmission Profile.
2. The Country of the Study Site for the specified Site Reporter.
3. The Country of the primary Reporter type of Contact (with a Rank of 1).
4. The Country on the primary Event (with a Rank of 1).

When you save the Inbox Item, Vault populates this field with Yes if any of the following fields contain a value or if the associated Reason Omitted is Masked:

Awareness Details section:

• Site Reporter

Contacts section (if the Contact is also reporter checkbox is selected):

• Qualification
• First Name
• Middle Name
• Last Name
• Organization
• Department
• Email Address
• Contact (Phone)
• Contact (Fax)
• Street
• City
• State/Province
• Country
• Zip/Postal Code

When you save the Inbox Item, Vault populates this field with Yes if any of the following fields contain a value or if the associated Reason Omitted is Masked:

Patient section:

• Patient Initials
• Gender
• Date of Birth
• Age at Onset
• Age Group
• MRN

Contacts section (if the Qualification value is Patient):

• First Name
• Middle Name
• Last Name

Vault populates this field with the assigned access group.

If details change, authorized users can run the Calculate Inbox Item Access Group action to recalculate this value. We recommend limited use of this action as it uses significant resources.