Inbox Item Field Reference

• Cannot be more than one (1) day in the future. This rule supports data entry in different time zones.
• Must be later than 1800/01/01.
• The Date of Death must be later than the First Admin Date, Last Admin Date, Adverse Event Onset and Cessation dates, as well as all dosage administration dates.
• The Last Admin Date must be later than the First Admin Date.
• Minimum precision required for New Info Date is the day.

• Only one record per section can be assigned rank 1 (primary), including Products, Medical Events, and Reporter-type Case Contact records.
• A Product record assigned rank 1 (primary) must have a value specified in the Product (Reported) field.

• Value and unit fields must specify both a value and unit, or neither.
• Text field values must adhere to the maximum number of characters.
• Number field values must adhere to the following limits:
  • Minimum value
  • Maximum value
  • Decimal places
  Note: Admins can view individual field limits for Inbox Item fields by viewing the corresponding fields on the Case object.

The confidence level of the Product match between the Inbox Item primary Company Product and the library Product.

Vault populates this field with one (1) of the following values:

• 1 - Exact Match (ID Match)
• 2 - Confident Match
• 3 - Likely Match
• 4 - Unlikely Match
• 5 - Unknown
• 6 - No ID or Name Match

See Configure Company Product Match Verification for more information about how Vault determines the Product Match Confidence.

This field appears only on imported Cases and does not appear on manually created Inbox Items.

This field does not appear on layouts by default and must be added by your Admin.

You can also select a different value for this field.

• Country
• Route of Administration
• Dose Form

Vault populates this field with the results of the match.

This field appears only on imported Cases and does not appear on manually created Inbox Items.

This field does not appear on layouts by default and must be added by your Admin.

• If the Site Reporter field is enabled by Veeva Support and your Admin, Vault checks if this field is populated. If populated, Vault uses the Country field on the site reporter's Study Site.
• If the Site Reporter field is not enabled for Inbox Items in your Vault or is not populated, Vault attempts to take the value from the Country field on the primary (rank 1) Reporter-type Case Contact.
• Finally, if the reporter country is not specified, Vault attempts to take the value from the Country field on the primary (rank 1) Adverse Event.

This field indicates whether the Inbox Item has an identifiable patient. When you save the Inbox Item, Vault checks for an identifiable patient in the Patient section.

When at least one (1) of the following fields in the Patient section OR the Case Contacts section with Patient Qualification is populated, this field is set to Yes:

If you mark one (1) or more of these fields as Masked, the patient or reporter will qualify as identifiable.

If you select any other Reason Omitted value besides Masked, Vault still considers the field to be blank.

This field is system managed and automatically populated.

This field indicates whether the Inbox Item has an identifiable reporter. When you save the Inbox Item, Vault checks for an identifiable reporter in the Case Contacts section.

When at least one (1) of the following fields in the Reporter-type Case Contacts section is populated, this field is set to Yes:

If you mark one (1) or more of these fields as Masked, the patient or reporter will qualify as identifiable.

If you select any other Reason Omitted value besides Masked, Vault still considers the field to be blank.

If the Site Reporter field is populated, Vault also sets this field to Yes.

This field is system managed and automatically populated.

The Literature Review in Vault SafetyDocs that includes the Literature Article used to create the Inbox Item.

Vault populates this field when a Literature Article is used to create an Inbox Item. Otherwise, you can select the Literature Review manually.

This field is related to the Create Inbox Items from Literature Articles feature in Vault SafetyDocs.

The Literature Article in Vault SafetyDocs that is the source for this Inbox Item.

Vault populates this field when a Literature Article is used to create an Inbox Item. Otherwise, you can select the Literature Article manually.

This field is related to the Create Inbox Items from Literature Articles feature in Vault SafetyDocs.

The assigned Access Group based on the Inbox Item.

Vault assigns Access Groups that share the most details with the Inbox Items, based on the following criteria:

• Sponsor
• Report Type
• Country
• Study Type
• Study
• Origin
• Intake Format and Method
• Market Segment

See Manage Case Access Group Security for more information.

• Manual Entry
• Document
• E2B
• JSON (API)
• Literature Article
• Tabular Data
• Data

• Manual Entry: Source document manually uploaded to the library or Inbox Item manually created
• Gateway: AS2
• Integration: API
• Import: E2B import to imported Case
• Email: Email to Inbox Item
• Online Questionnaire: Inbox Item created from an online questionnaire for follow-up post-marketing Cases
• Literature Promotion: Inbox Item created from a Literature Article in Vault SafetyDocs.
• Medical-Safety Connection: Data transferred from Vault Medical using the Medical-Safety Vault Connection
• CDMS Connection: Data transferred from Vault CDMS using the Safety-EDC Vault Connection

For reporting to the PMDA, select whether the Case is a Safety Measure Report or a Research Report.

Optionally, contact Veeva Managed Services to have additional options created for this field. This is useful in situations, like Special Report Classifications for Japan, when Cases should be reported to certain destinations only. When evaluating reporting rules, Cases with Special Report Classification values are always excluded unless this parameter is specified in the Safety Rule Set. See Reporting Rule Parameter Reference for more information.

This field does not appear on layouts by default and must be added by your Admin.

The user assigned to the Inbox Item. This user can reassign a locked Inbox Item or clear it to unlock the Inbox Item.

This field does not appear on layouts by default and must be added by your Admin.

Select the Follow-Up Rule for the questionnaires with which Vault should attempt to match the Case or Inbox Item. If you leave this field blank and populate the Send Follow-Up field, Vault uses Invalid Case (Missing Parameters) as the default value. See Send a Follow-Up Email Questionnaire to a Case Reporter for more information.

This field does not appear on layouts by default and must be added by your Admin.

Select this field to trigger Vault to evaluate whether this Case or Inbox Item matches the criteria for one (1) or more questionnaires. After running the process to generate questionnaires, Vault clears this field. See Send a Follow-Up Email Questionnaire to a Case Reporter for more information.

This field does not appear on layouts by default and must be added by your Admin.

The Significance classification of the Inbox Item.Vault populates this field with one (1) of the following values:

• Initial Case
• Non-Significant Follow-Up
• Significant Follow-Up
• Urgent Significant Follow-Up

See Import an Inbox Item for more information.

(Required) The date of the most recent follow-up information from a primary source.

Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. Time is optional.

The Study associated with the report.

Select the Study.

Upon promoting an Inbox Item, with the exception of system-generated Inbox Items containing a Study with unspecified products, Vault snapshots the preconfigured information from the Study library to populate details from this Study on the Case, including the Study Registration, Products, Dosage, and Indication.

Upon promoting a system-generated Inbox Item containing a Study with unspecified products, the imported Study Name and Number are used instead of those from the Study library.

See Manage Studies for more information.

Upon Case promotion, Vault snapshots the preconfigured information from the Study library to populate details from this Study Arm on the Case, including the Products, Dosage, and Indication. For blinded Study Arms, placeholder Case Products are created using the Blinded Name. For open arms, the Study Products are snapshotted to the Case.

For this field to appear, the Site Reporter feature must be enabled in your Vault and the Report Type must be set to Study.

Select a contact from the chosen Study Site. Once you promote the Inbox Item to a Case, Vault creates the primary reporter using the selected Site Reporter and Study Site.

Populating this field disables the Case Contact records. Upon Case promotion, any Case Contact records are copied to the Case.

See Add a Study Contact for more information.

This field does not appear on layouts by default. Contact Veeva Support to enable this field in your Vault. Your Admin must then add it to the Inbox Item layout.

Enter the Case Identifier (reference number). This value will be referenced for duplicate detection.

Select one (1) of the following Type options:

• To include the Case Identifier and Source fields on the E2B Transmission document upon E2B export, select E2B Re-Transmittable.
• Otherwise, select Non-Transmittable.

Your Admin can configure additional Case Identifier Types.

Enter the Source of the Case Identifier. This field is required if you set the Type to E2B Re-Transmittable.

If the Inbox Item was imported, Vault populates the Source Data panel with the Case Identifier information. If it was imported from an E2B file, Vault sets the Type to E2B Re-Transmittable.

For Inbox Item records created from the Medical-Safety Vault Connection, Vault sets the Case Identifier Type to Vault Medical.

You can add up to 20 Case Identifiers on each Inbox Item.

Vault populates this field with the appropriate data from EDC.

For this field to appear, the Safety-EDC Vault Connection must be enabled in your Vault.

When a user clears an SAE or deletes a subject in EDC, Vault populates this field to indicate that any corresponding Case must be voided or nullified.

For this field to appear, the Safety-EDC Vault Connection must be enabled in your Vault.

Identifies a Reporter-type Case Contact.

Select this field if the case contact reported the adverse event. If you select this field, the contact becomes a Reporter-type Case Contact upon Case promotion.

To be valid, a case must contain at least one Reporter-type Case Contact.

Enter the state or province where the contact resides.

For primary Reporter-type contacts on Domestic Cases, if a country is entered and has an associated Country state/province record for mapping domestic state codes, the State/Province field includes a picklist of states and provinces. If no record is found, enter the state or province as text.

Use this field to identify an Inbox Item as a Pregnancy Case for tracking pregnancy exposure or for reporting an adverse event experienced by the mother. See Add a Pregnancy Case for more information.

This field does not appear on layouts by default and must be added by your Admin.

The patient's age at the onset of the adverse event. Vault automatically calculates this field upon Case promotion. If you manually enter a value, and Vault later auto-calculates this field, the field is overwritten by the auto-calculated value.

Auto-Calculation

When you promote to Case, Vault automatically calculates this field using the time interval between the following dates:

• The Case Date of Birth
• The Case Adverse Event Event Onset. If an Event Onset is not available, Vault uses the Case Receipt Date.

When only partial dates are available, Vault calculates the age using the first day in the month or year entered. For example, if only "2021" is entered, the date 1/1/2021 is used.

Vault automatically calculates this field upon Case promotion or when the Age at Onset field on the Case is updated. If you manually enter a value, and Vault later recalculates this field, the field is overwritten by the auto-calculated value.

Auto-Calculation

Vault automatically calculates the age group based on the value in the Age at Onset field and the above criteria.

• GP MRN — D.1.1.1 (R3) | B.1.1.1a (R2)
• Hospital MRN — D.1.1.3 (R3) | B.1.1.1c (R2)
• Investigation MRN — D.1.1.4 (R3) | B.1.1.1d (R2)
• Specialist MRN — D.1.1.2 (R3) | B.1.1.1b (R2)

• Case Product
• Drug History

Upon Case promotion, this classification determines whether this product becomes a Case Product or a Drug History record.

For Products of Case Product type, if the Study Arm field is not blank, Vault automatically populates this field with Concomitant. You can not edit this field.

If the Study Arm field is blank, select the characterization of the Drug Role in the Adverse Event as provided by the primary reporter or sender.

A valid Individual Case Safety Report (ICSR) must include at least one Case Product with a Drug Role of either Suspect, Interacting, or Drug Not Administered.

The following options are available by default, however your Vault may have additional Drug Role Controlled Vocabularies configured:

For Device-type Case Products to appear on generated MedWatch 3500A reports, the Drug Role must be Interacting, Suspect, or Drug Not Administered.

This field appears for Inbox Item Study Cases.

Select the Study Product name.

For blinded Studies, select the masking state (Blinded, Open Label, or Unblinded), and then select the Study Product name or the Blinded Name (Study Product Placeholder).

See Manage Studies for more information about adding Study Products.

The indication for product use as reported by the primary source.

Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.

The language dropdown menu shows the MedDRA dictionary language being used. English is selected by default.

For more information, see Code MedDRA Terms.

• To enter a specific time interval, select either the first or second option depending on the preferred format.
• If the dosage regimen is not specific to a time interval, or the exact frequency is unknown, select the third option and specify whether the regimen was Cyclical or As Necessary.

  If only the total product dosage is provided, select Total in the third option. For example, if a patient took 100mg of a drug in total, enter "100mg" in the Dose field and select Total in the Frequency field.

Select an option from the picklist or use a custom entry.

Vault Safety supports a selection of dose form terms, including terms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) and the Medicines and Healthcare products Regulatory Agency (MHRA)

Encoded dose forms in E2B reports received and imported into Vault Safety will be mapped using these dictionary entries, including E2B(R2) codes received from the MHRA.

• Adverse Event
• Medical History & Concurrent Conditions

Upon Case promotion, this classification determines whether this event becomes a Case Adverse Event or Medical History record.

Description of the medical event, as reported by the primary source.

Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.

The language dropdown menu shows the MedDRA dictionary language being used. English is selected by default.

For more information, see Code MedDRA Terms.

• fatal: Select this option when the patient's death is suspected to be related to the adverse event.
• not recovered/not resolved/ongoing: Select this option when the patient had not recovered from the adverse event or for an irreversible congenital anomaly.
• recovered/resolved: Select this option if the patient has fully recuperated from the adverse event.
• recovered/resolved with sequelae: Select this option for an irreversible medical condition.
• recovering/resolving: Select this option if the patient is recuperating from the adverse event.
• unknown: Select this option when the outcome is unknown.