Inbox Item Field Reference

Learn about the standard fields available for verification and data entry on an Inbox Item.

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This article describes the fields available for data entry on the Inbox Item. The fields are arranged in the order they appear on the page layout provided in the Vault Safety template. You may see additional fields or a different layout, depending on your vault’s configuration.

You can also sort Inbox Items by certain fields on the Inbox tab. For example, sorting by New Info Date to view late Cases.

sort-inbox-items-by-new-info-date
Sort Inbox Items by New Info Date

Inbox Item Data Entry Validation

Inbox Items are validated during data entry and verification. Additional validations may occur during Case promotion, according to set validation rules.

If an Inbox Item does not meet the following criteria, you cannot save or verify that section.

Note Custom validation rules are not supported on Inbox Items.

Data Validation Rules
Dates
  • Cannot be in the future.
  • 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.
Details New Info Date and Report Type fields are required.
Medical Events The Type field is required for all Medical Events.
Products The Type field is required for all Products.
Patient An Inbox Item can only contain one Patient-type Case Contact record.
Rank
  • 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.
All Fields
  • 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.

Organization and Region Section

The Organization and Region section specifies the associated Organization and whether this Case will be domestic or global.

Inbox Item Organization and Region
Inbox Item Organization and Region
Field Description
Organization (Required) This field designates the sponsor Organization.
Select the sponsor Organization. If your account is affiliated with only one Organization in your vault, the system populates this field automatically.
Localization The local language the source report was received in.
Select the appropriate locale to make dual language (local to English) data entry available.
To learn more, see Perform Local Language Intake.

Case Validity and Source Section

The Case Validity and Source section contains fields that identify whether the Inbox Item has enough information to qualify as a valid ICSR.

Inbox Item Case Validity and Source
Inbox Item Case Validity and Source
Field Description
Study The name of the Study associated with the Inbox Item and a link to the Study in the Business Admin library. If this field is blank, a Study is not specified.
This field is system managed and automatically populated. Do not manually select a study in this field.
Company Product The name of the primary (Rank 1) Product on the Inbox Item and a link to the Product in the Business Admin library. If this field is blank, a Product is not specified.
This field is system managed and automatically populated.
Adverse Event The name of the primary (Rank 1) Adverse Event on the Inbox Item. If this field is blank, an adverse event is not specified.
This field is system managed and automatically populated.
Country The name of the country identified on the Inbox Item. If this field is blank, a country is not specified.
This field is system managed and automatically populated. The system uses the following logic to populate this field:
  • First, the system attempts to take the value from the Country field on the primary (Rank 1) Reporter-type Case Contact.
  • If the reporter country is not specified, the system attempts to take the value from the Country field on the primary (Rank 1) Adverse Event.
Identifiable Patient This field indicates whether the Inbox Item has an identifiable patient. When you save the Inbox Item, the system checks for an identifiable patient in the Patient section.

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

Patient Case Contacts
  • Patient Initials
  • Gender
  • Date of Birth
  • Age at Onset
  • Age Group
  • MRN
  • First Name
  • Middle Name
  • Last Name

If you mark one or more of these fields as Masked, the patient or reporter will qualify as identifiable.
Note that if you select any other Reason Omitted value besides Masked, the system still considers the field to be blank.

This field is system managed and automatically populated.
Identifiable Reporter This field indicates whether the Inbox Item has an identifiable reporter. When you save the Inbox Item, the system checks for an identifiable reporter in the Case Contacts section.

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

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

If you mark one or more of these fields as Masked, the patient or reporter will qualify as identifiable.
Note that if you select any other Reason Omitted value besides Masked, the system still considers the field to be blank.

This field is system managed and automatically populated.
Source Document The source document for the report. Use the link in this field to navigate to the source document.
The system populates this field automatically when a document is used to create the Inbox Item. Otherwise, you can select the document manually.

Note The Source Document field is not version-specific and links to the latest document version.

Details Section

Use the Details section to enter general information about the report.

Inbox Item Details Section
Inbox Item Details Section
Field Description
Priority The priority level of this report.
Select the appropriate priority.
New Info Date (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. You must specify the year, month, and day at a minimum. Time is optional.
Report Type (Required) The method in which the adverse event was reported by the primary source.
Select the appropriate report type.
Study The Study associated with the report. Depending on your vault's configuration, this field may be hidden when the Report Type field is not set to Study.

Select the Study. A Study must have Study Arms or Unspecified Products to be used to manually create Inbox Items.

Upon promoting an Inbox Item, with the exception of system-generated Inbox Items containing a Study with Unspecified Products, the system 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.

To learn more, see Manage Studies.
Study Arm

For manual intake, select the Study Arm that the suspect product is associated with.

Upon Case promotion, the system 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.

Note You cannot edit this field in the following scenarios:

  • If you select a Study with Unspecified Products (a Study placeholder).
  • When an Inbox Item is imported from an E2B file.
Worldwide UID The worldwide unique case identification (WWUID) number for an external safety case. For example, a previously submitted case received from an MAH or partner.
If the Case is imported from an E2B file that contains a worldwide UID (A.1.10.1/C.1.8.1), this field value is imported from the E2B file. Otherwise, you can enter the value manually for external cases. If left blank, the system automatically populates the field upon Case promotion using the Organization UID Code.
External System UID Unique Identifier for an external system.
You can manually enter the External UID.
Reporter's Comments
Enter the reporter's comments on the causality assessment, diagnosis, or other relevant topics.

Contacts Section

Use the Contacts section to capture information about the reporter and other relevant contacts.

Note An Inbox Item can contain only one Patient-type Case Contact record.

Inbox Item Case Contacts Section
Inbox Item Case Contacts Section
Field Description
Rank The Reporter-type Contact ranked as 1 identifies the primary Reporter.
To order Case Contacts by rank, enter the rank number. Ranked records appear in ascending order.
Qualification The contact's qualification.
Start typing for instant search or select the binoculars icon browse the available options. Select Patient to designate this contact a Patient-type Case Contact.
Contact is also Reporter 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.
Additional Information
Enter any additional information that cannot be captured in the other contact fields.
Title
Enter the contact's title.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
First Name
Enter the contact's first name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Middle Name
Enter the contact's middle name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Last Name
Enter the contact's last name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Organization
Enter the name of the contact's organization.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Department
Enter the name of the contact's department in their organization.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Reporter Language This field is disabled if the contact is not a Reporter.
Select the Reporter's language from the dropdown menu.
Email Address
Enter the contact's email address.
Contact (Phone or Fax) A contact number for the individual.
In the first field, select either Phone or Fax. In the second field, enter the contact number.
Street
Enter the contact's street address.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
City
Enter the name of the city where the contact resides.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
State/Province
Enter the state or province where the contact resides.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Country
Select the country where the contact resides.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Zip/Postal Code
Enter the contact's zip or postal code.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Patient Section

Use the Patient section to capture information about the patient who experienced the adverse event.

Inbox Item Patient Section
Inbox Item Patient Section
Field Description
Patient Initials
Enter the patient's initials.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Gender
Select the patient's gender.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Height The patient's height.
In the first field, enter a number. In the second field, select the unit of measurement.
Date of Birth The patient's birth date.
Use the Calendar pop-up tool to select a date or enter the date manually. For this field to be exported to E2B Transmissions, the full date is required with year, month, and day.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Age at Onset The patient's age at the onset of the adverse event.
The system automatically calculates this field upon Case promotion. If you manually enter a value, and the system later auto-calculates this field, the field is overwritten by the auto-calculated value.
Auto-Calculation

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

  1. The Case Date of Birth
  2. The Case Adverse Event Event Onset. If an Event Onset is not available, the system uses the Case Receipt Date.

When only partial dates are available, the system 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.
Age Group The patient's age group at the onset of the adverse event, according to the following criteria:
Age Group Age at Onset
Fetus 0 weeks/days/hours/minutes old
Neonate More than 0 to less than 4 weeks old
Infant 4 weeks to less than 12 months old
Child 1 year to less than 12 years old
Adolescent 12 years to less than 18 years old
Adult 18 years to less than 65 years old
Elderly 65 years and older
The system 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 the system later recalculates this field, the field is overwritten by the auto-calculated value.
Auto-Calculation
The system automatically calculates the age group based on the value in the Age at Onset field and the above criteria.
Date of Death Enter the date when the patient was reported as deceased.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
MRN The type of MRN that you want to enter. The following options are available:
  • 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)
Select the MRN type from the drop-down list. Once you select the MRN type, the MRN Text field appears.
MRN Text The MRN number corresponding to the type selected in the MRN field.
Enter one or more sets of MRN numbers. For this field to appear, you must select the MRN type from the MRN field.

Products Section

Use the Products section to capture case products and drug history. When the Inbox Item is promoted to a Case, the appropriate Case Products and Drug History records are created according to the Product Type.

For manual Study report intake, the Product section is meant only to capture concomitant medication and drug history. When a Study Arm is selected in the Details section, the system snapshots the appropriate Study Case Products to the Case from the Study library.

If all Product fields (excluding Rank, Type, and Drug Role) are left blank, the system ignores the Case Product when promoting to Case.

If you add a new Product record, the system automatically populates that record Type as Case Product. You can edit this field.

Product Fields

Inbox Item Products Section
Inbox Item Products Section

Note If the Product Type is set to Drug History, you can only specify the Rank and Product fields.

Field Description
Rank The Case Product ranked as 1 identifies the primary product.
To order products by rank, enter the rank number. Ranked records appear in ascending order.
Type (Required) This field allows you to classify the product as either:
  • Case Product
  • Drug History

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

For Products of Case Product type, if the Study Arm field is not blank, the system 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:

Drug Role Option Description
Suspect Identifies a product suspected to have contributed to the adverse event.
Interacting Identifies a product suspected to have an interaction with another product.
Concomitant Identifies a product taken by the patient at the time the reaction was observed.
Drug Not Administered Identifies a product that was not administered, but must be reported. For example, in a clinical trial setting or due to a product administration error.
Similar Device Identifies a US-marketed product (such as a vaccine) that contains the same or similar device as the suspect product for which a malfunction was reported. This option is used in FDA VAERS submissions for scenario 10 (a malfunction combination product with a similar device).
Treatment Identifies products used to treat the adverse event. This drug role is for tracking purposes only and does not appear on generated regulatory reports.

For Device-type Case Products to appear on generated MedWatch 3500A reports, the Drug Role must be Interacting or Suspect.
Product
Enter the name of the product, as reported by the source.
Company Product The Company Product that is suspected to be associated with the adverse event.
When manually selecting the Product, this drop-down menu lists Products in the Product Library for the Inbox Item Organization.
To learn more, see Manage Products.
Study Product A link to the Study Product, as configured in the Study Library. This field appears for E2B imported Inbox Items only.
To learn more, see Add a Study Product.
Registration A link to the Product Registration record, as configured in the Product Library.
If the product registration details are already configured in the Product library, select the Product Registration record.
To learn more, see Add Product Registration Details.
Country Obtained
Select the country where the product was obtained.
Indication 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.

To learn more, see Code MedDRA Terms.

Dosage Fields

You can capture Dosage information for Case Product-type products.

Inbox Item Dosage Fields
Inbox Item Dosage Fields
Field Description
Dose Combined value and unit field to capture the amount of product administered in each dose.
Manually enter the (numeric) dose value in the first field. Select the unit of measure for the dose unit from the drop-down menu.
Frequency Enter the frequency of the administered dose. Once you save the page, the system will calculate and display an E2B-compliant description of the values. For example, Every 6 hours or 4 times per day (.250 days).
  • 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 only took 100mg of a drug in total, you should enter 100mg in the Dose field and select Total in the Frequency field.
First Admin Date
Enter the date and time (if available) when the product was first administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Last Admin Date
Enter the date and time (if available) when the product was last administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Duration Combined number and unit field to capture the overall duration of time that the product was administered to the patient.
The system auto-calculates this field upon Case promotion if the First Admin Date and Last Admin Date are provided.
Batch/Lot Number
Enter the batch or lot number for the medicinal product.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Dose Form Description of the pharmaceutical dose form.

Select the pharmaceutical dose form of the product 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.
Patient RoA Route of administration code for the patient.
Select an option from the drop-down list or create a custom entry.
Dose Text
Enter a description of the dosage when structured information cannot capture this information or more details are required.

Medical Events Section

Use the Medical Events section to capture adverse events and medical history. When the Inbox Item is promoted to a Case, the appropriate Case Adverse Events and Medical History records are created according to the Medical Event Type.

If you add a new Medical Event record, the system automatically populates that record Type as Adverse Event. You can edit this field.

Inbox Item Medical Events Section
Inbox Item Medical Events Section

Note If the Type is Medical History & Concurrent Conditions, you can only specify the Rank, Event, Onset, and Cessation fields.

Field Description
Rank The Adverse Event ranked as 1 identifies the primary adverse event.
To order Medical Events by rank, enter the rank number. Ranked records appear in ascending order.
Type (Required) This field allows you to classify the event as either:
  • Adverse Event
  • Medical History & Concurrent Conditions

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

To learn more, see Code MedDRA Terms.
Event Country
Select the country where the adverse event occurred.
Seriousness The level of impact the adverse event had on the patient. You can enter multiple values in this field.
Select one or more seriousness criteria to describe the level of impact the adverse event had on the patient. If the event is not serious, do not select a value in this field.
Onset The date on which the adverse event or reaction started.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Cessation The date when the adverse event ended.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Outcome Select the outcome of the adverse event:
  • 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.
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