# Inbox Item Field Reference This article describes the fields available for _Inbox Item_ data entry. Vault populates certain fields based on your Admin's configuration and, for generated _Inbox Items_, based on source data. Sections load asynchronously on generated _Inbox Items_. You can view the data in that section when it finishes loading and you can edit data when all sections finish loading. To modify values, select the **Edit** (edit-icon) icon on the record's detail page. Some fields populated by Vault are read-only and you cannot modify them. When editing, you can select any **Delete** button to mark the associated section for deletion. When selecting values from drop-downs, field values are accent-sensitive (entering a value with an accent prioritizes results with accents). When you save an _Inbox Item_, Vault validates field values to ensure accuracy.
## General Page {#general} This page contains general details about the report. ### Promotion Status Section Fields {#status} This section displays on _Inbox Items_ in _Marked as Follow-up_ or _Promoted_ status and includes information about the _Inbox Item's_ status, which you cannot modify. When Vault archives a promoted _Inbox Item_ 180 days after the last record update, the section name updates to _Inbox Item has been archived_. The following fields may be available: | Field | Description | | --- | --- | | _Status_ | Vault populates the record's lifecycle state and date of the status update. | | _Linked to_ | Vault populates a link to the associated _Case_. | ### Awareness Details Section Fields {#awareness} This section includes information about the case, including priority, type, study, and identifiers. The following fields may be available:
Field Description
Priority Vault populates this value based on the top-ranked adverse event. You can modify this value, if needed.
New Info Date Specify the date of the most recent follow-up information from a primary source. Use the calendar to select a date or enter a date manually. Specify the year, month, and day at a minimum. Time is optional.
Report Type Select the method by which the primary source reported the adverse event. For Inbox Items generated from an email, Vault populates this value with the Pre-Populate Report Type value of the sender's associated Transmission Profile.
Study

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.
Study Arm

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.
Site Reporter Select a contact from the Study Site associated with the specified Study. This field displays if your Vault uses study site reporters and you selected Study for Report Type. When you promote the Inbox Item, Vault creates the Case Contact primary reporter using the specified Site Reporter and Study Site. Populating this field inactivates the Contacts section.
Reporter's Comments Enter the reporter's comments on the causality assessment, diagnosis, or other relevant topics.
Worldwide UID Enter the worldwide unique case identification (WWUID) to identify an external safety case, such as a previously submitted case received from an MAH or partner. For Inbox Items generated from imported E2B files, Vault populates this value if the file contains a worldwide UID (A.1.10.1/C.1.8.1). If you leave this field blank, Vault populates a value upon promotion using the Organization UID Code of the specified Organization.
External System UID Enter a unique identifier (UID) for an external system.
Case Identifier(s) Add up to 20 unique identifiers. Vault references these values for duplicate detection. Select the plus (+) icon to add an identifier or the delete (x) icon to remove an identifier.
  • 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.
For Inbox Items generated by Veeva Connections and Web Intake Forms, Vault populates the Case Identifier and Type.
### Report Details Section Fields {#report} This section includes information about the report, including localization, intake, special considerations, and significance. The following fields may be available:
Field Description
Localization

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.
Intake Method Vault populates the method of intake for the Inbox Item.
Intake Format Vault populates the format used to create the Inbox Item.
Special Situation Select any special situations for the case which may require additional consideration.
Invalid Reason Select any reasons for which the case is invalid and does not meet minimum qualifiable details.
Special Report Classification For reporting to the PMDA, select any special classification. Populating this field hides the Patient section.
Rejection Reason Vault populates this field for imported Inbox Items in Rejected state. You can review inbound validation results in the Conformance Validations section.
Market Segment Vault populates this field with the market segment associated with the Study for study cases or the primary Product for postmarket cases.
Significance For Inbox Items generated by the Safety-EDC Connection, Vault populates this field based on your Admin's configuration.
## AER Page {#aer} This page contains information about the adverse event report. ### Patient Section Fields {#patient} This section includes information about the patient who experienced the adverse event. The following fields may be available:
Field Description
Patient Initials Enter the patient's initials. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Sex Select the patient's sex at birth. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Date of Birth Specify the patient's birth date. Use the calendar to select a date or enter a date manually. To export this field to E2B transmissions, enter the full date (year, month, and day). If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Age at Onset Vaul populates the patient's calculated age at the onset of the adverse event. Upon promotion, Vault overwrites any manually entered value with the calculated value.
Age Group Vault populates the patient's calculated age group at the onset of the adverse event. Upon promotion, Vault overwrites any manually entered value with the calculated value.
Date of Death Specify the date on which the patient was reported as deceased. Use the calendar to select a date or enter a date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
MRN Select the type of medical record number (MRN) that you want to enter. When you select the MRN type, the MRN Text field appears.
MRN Text Enter one or more sets of MRN numbers corresponding to the specified MRN.
Pregnancy Case Select a value to identify this report as a Pregnancy Case, which allows you to track pregnancy exposure or report an adverse event experienced by the mother.
### Contacts Section Fields {#contacts} This section includes information about the reporter and other relevant contacts. An _Inbox Item_ must include exactly one _Patient_ type of _Qualification_ and at least one _Reporter_ type of _Qualification_. When imported _Inbox Items_ include sender information, Vault adds these details to the _Inbound Transmission_. The following fields may be available:
Field Description
Rank Enter a numeric value to order contacts by rank. The Reporter type of Contact ranked as 1 identifies the primary reporter. When you save the Inbox Item, ranked contacts display in ascending order.
Qualification Select the type of contact. Selecting Patient designates this contact as a Patient type of Case Contact upon promotion.
Contact is also Reporter Select this checkbox to identify the adverse event reporter. If you select this option, the contact becomes a Reporter type of Case Contact upon promotion.
Country Select the contact's country. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable. For Inbox Items generated from an email, Vault populates the Pre-Populate Country value of the sender's associated Transmission Profile.
State/Province

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.
Reporter Language If you selected Reporter for the Qualification, select the reporter's language. This field is inactive for all other Qualifications.
First Name Enter the contact's first name. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Last Name Enter the contact's last name. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Email Address Enter the contact's email address.
Email Consent Provided Select this checkbox if the reporter has provided email consent to be contacted for more information.
### Products Section Fields {#products} This section includes information about products, drug history, and each _Case Product's_ [dosage details][1]. Select the plus (**+**) icon to add a new _Product_ or the _Delete_ button to mark one for removal. You can also add up to ten _Study Products_ using the _Specify Study Products_ action. Upon promotion, Vault creates the appropriate _Case Products_, along with their related records. The following parameters apply to this section: * A valid Individual Case Safety Report (ICSR) must include at least one _Product_ with a _Drug Role_ of _Suspect_, _Interacting_, or _Drug Not Administered_. * If you do not populate all _Product_ fields, excluding _Rank_, _Type_, and _Drug Role_, Vault ignores the _Case Product_ upon promotion. * For manual _Study_ report intake, this section captures concomitant medication and drug history. If you specify a _Study Arm_, upon promotion, Vault maps the associated study _Case Products_ to the _Case_ from the associated _Study_. * When you add a _Company Product_ type of _Product_, upon promotion, the _Transmission Product Type_ from the _Registered As_ of the _Product Registration_ maps to the _Globally Registered As_ field of the _Product_. * For _Drug History_ types of _Products_, you can specify only _Rank_ and _Product_. * Depending on your Admin's configuration, suspect _Case Products_ may include those with a _Drug Role_ of _Drug Not Administered_. The following fields may be available:
Field Description
Rank

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.
Type Select the type of product. When you manually add a new Product, Vault assigns the Case Product value, which you cannot modify. Upon promotion, this classification determines whether Vault generates a Case Product or a Drug History.
Drug Role

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.

Country Obtained Select the country from which the product was obtained.
Product Enter the product reported by the source. If you haven't specified a Study, you can code the product to relevant matches in your Product library.
Company Product

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.
Study Product

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.
Registration Vault populates the Product Registration of the coded Product, when available. If Vault does not populate this field, select the appropriate value.
Indication Enter the reported product indication term reported by the primary source to code the MedDRA term. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
#### Dosage Subsection Fields {#dosage} This product subsection includes information about dosages for _Case Product_ types of _Products_. Select the plus (**+**) icon to add a new _Dosage_. You can add up to ten _Dosages_ per _Product_ (after promotion, you can add additional _Dosages_ to the _Case_). You can select the **Copy** (Copy Icon) icon to copy a _Dosage_ section or the **Delete** (Delete Icon) icon to mark it for deletion. The following fields may be available:
Field Description
Dose Enter the numeric dose value in the first field and select the unit of measurement or select the plus (+) icon to enter a custom entry to indicate the amount of product administered at one time.
Frequency

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)".
First Admin Date Enter the date and time (if available) at which the product was first administered. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Last Admin Date Enter the date and time (if available) at which the product was last administered. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Duration Vault populates this field upon promotion based on the specified First Admin Date and Last Admin Date values to capture the overall duration of time that the product was administered to the patient.
Batch/Lot Number Enter the batch or lot number for the medicinal product. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Dose Form Select a dose form or select the plus (+) icon to enter a custom entry. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Patient RoA Select a route of administration (RoA) code for the patient or select the plus (+) icon to enter a custom entry. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Dosage Text Enter a description of the dosage for any relevant information not captured in the other Dosage fields.
### Events Section Fields {#events} This section includes information about adverse events and medical history. When you add a new event, Vault populates the _Type_ as _Adverse Event_, which you can modify. Upon promotion, Vault creates the appropriate _Case Adverse Event_ and _Case Medical History_ records according to the specified _Type_. If you select _Medical History & Concurrent Conditions_ for the _Type_, you can only specify the _Rank_, _Event_, _Onset_, and _Cessation_ fields. The following fields may be available:
Field Description
Rank Enter a numeric value to order events by rank. The event ranked as 1 identifies the primary adverse event. When you save the Inbox Item, ranked records display in ascending order.
Type Select the type of event reported.
Event Enter the reported medical event terms reported by the primary source to code the MedDRA term.
Event Country Select the country in which the adverse event occurred. For imported Inbox Items, Vault may populate this field with a suggested country.
Seriousness Select the level of impact the adverse event had on the patient. If the event is not serious, leave this field blank.
Onset Specify the date on which the adverse event or reaction started. Use the calendar to select a date or enter a date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Cessation Specify the date on which the adverse event ended. Use the calendar to select a date or enter a date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Outcome Select the outcome of the adverse event.
## Activities Page {#activities} This page contains information about Vault-identified qualifications, validations, and transmissions. ### Qualifications Section Fields {#qualifications} This section includes information about if the report has enough identifiable details to qualify as a valid ICSR. Vault populates the values in this section based on values in _Inbox Item_ fields. The following fields may be available:
Field Description
Identifiable Company Product When you save the Inbox Item, Vault populates this field with Yes if the Company Product field contains a value or if the specified Study has a specified Product.
Study Vault populates this field based on the Study specified in the Awareness Details section.
Company Product Vault populates this field based on the specified Product to indicate the product suspected to be associated with the adverse event. For deprecated Products and Product Registrations, a DEPRECATED tag displays.
Product Match Confidence Vault populates this field with the confidence score of the matched Product.
Country Vault populates this field based on the following priority order:
  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).
Adverse Event Vault populates this field based on the primary event with the Rank of 1.
Identifiable Reporter

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
Identifiable Patient

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
### Conformance Validations Section {#validations} For imported _Inbox Items_, this section displays all related _Inbound Validation Results_ and contains the E2B validation results for the _Transmission Profile_. ### Transmissions Section {#transmissions} This section displays all related _Transmissions_, including _Inbound Transmissions_. ## References Page {#references} This page contains reference details about the case. ### Related Cases Section Fields {#cases} This section displays related records. The following fields may be available: | Field | Description | | --- | --- | | _Case_ | Upon promotion, Vault populates this field with a link to the generated _Case_. | | _Linked Inbox Item_ | If a user has marked this _Inbox Item_ as a duplicate, Vault populates this field with a link to the original _Inbox Item_. | ### Inbox Source Section Fields {#source} This section displays after saving a new _Inbox Item_ and includes information about source data. The following fields may be available:
Field Description
Source Document Vault populates this field for Inbox Items generated from a document. For manual Inbox Item creation, you can select the applicable document. This always links to the latest document version.
Source Questionnaire Vault populates this field for Inbox Items generated from a completed online questionnaire.
Number of Cases Vault populates this field based on the specified Literature Article to indicate the number of Cases to which Vault will promote this Inbox Item when you run the Promote to Multiple Cases action.
EDC Subject Information Vault populates this field for Inbox Items generated from the Safety-EDC Connection based on data received from EDC.
Source Literature Review Vault populates this field based on the specified Literature Article.
Source Literature Article Vault populates this field for Inbox Items generated from a Literature Article.
### Documents Section {#documents} This section displays all related documents. ### System Section Fields {#system} This section includes information about the record. Vault populates and updates most of the fields in this section. The following fields may be available:
Field Description
Organization Select the sponsor. Vault may populate this field based on source data or if your account is affiliated with a single Organization.
Access Group

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.
[1]: #dosage