Sections in This Article
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.
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.
Note that picklist field values are accent-sensitive; entering a value with an accent prioritizes results with accents.
You can also sort Inbox Items by certain fields on the Inbox tab. For example, sorting by New Info Date to view late Cases.
Inbox Item Data Entry Validation
Inbox Items are validated during data entry and verification. You receive error messages that prompt you to make corrections to invalid data. 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 |
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Dates |
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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 contain only one (1) Patient-type Case Contact record. Additional details can be added in the Patient section. |
Rank |
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All Fields |
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Organization and Region Section
The Organization and Region section specifies the associated Organization and whether this Case will be domestic or global.
Field | Description |
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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 to English 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.
Field | Description | ||||
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Study | The name of the Study associated with the Inbox Item and a link to the Study in the Business Admin > Objects 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 > Objects library. If this field is blank, a Product is not specified. This field is system managed and automatically populated. | ||||
Product Match Confidence |
The confidence level of the Product match between the Inbox Item primary Company Product and the library Product. The system populates this field with one of the following values:
To learn more about how the system determines the Product Match Confidence, see Must Match and Should Match Confidence Outcomes. You can also select a different value for this field. This field appears only on imported Cases and does not appear on manually created Inbox Items. This field does not appear on page layouts by default and must be added by your Admin. |
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Product Match Criteria |
The fields by which the Inbox Item primary Company Product Registration and Library Product Registration must or should match based on Admin configuration. These fields include:
The system 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 page layouts by default and must be added by your Admin. |
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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. The system populates this field based on the information entered in the Medical Events section if the Type is set to Adverse Event and the Rank is set to 1. | ||||
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:
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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:
If you mark one or more of these fields as Masked, the patient or reporter will qualify as identifiable. |
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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:
If you mark one or more of these fields as Masked, the patient or reporter will qualify as identifiable. If the Site Reporter field is populated, the system also sets this field to Yes. This field is system managed and automatically populated. |
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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. |
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Access Group |
The assigned Access Group based on the Inbox Item.
The system assigns Access Groups that share the most details with the Inbox Item, based on the following criteria:
Note If Inbox Item or Access Group details change, authorized users can trigger Access Group recalculation manually using the Calculate Inbox Item Access Group action. We recommend limited use of this action, which takes up significant system resources. |
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Intake Format |
The format used to create the Inbox Item. The options include:
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Intake Method |
The method of intake for the Inbox Item. The options include:
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Special Report Classification | This field applies to Cases reportable to the PMDA only. Select whether the Case is a Safety Measure Report or a Research Report for PMDA. This field does not appear on page layouts by default and must be added by your Admin. | ||||
Assigned To | 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 page layouts by default and must be added by your Admin. | ||||
Follow-Up Rule | Select the Follow-Up Rule for the questionnaires with which the system should attempt to match the Case, Inbox Item, or AER. If you leave this field blank and select Send Follow-Up, the system uses Invalid Case (Missing Parameters) as the default value. To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter. This field does not appear on page layouts by default and must be added by your Admin. | ||||
Send Follow-Up | Select this field to trigger the system to evaluate whether this Case, Inbox Item, or AER matches the criteria for one or more questionnaires. After running the process to generate questionnaires, the system clears this field. To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter. This field does not appear on page layouts by default and must be added by your Admin. |
Details Section
Use the Details section to enter general information about the report.
Field | Description |
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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. 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.
Select the Study. 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. |
Study Arm |
Select the Study Arm that the suspect Product is associated with, if applicable.
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:
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Site Reporter |
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 Study Contact from the chosen Study Site. Once you promote the Inbox Item to a Case, the system 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. To learn more, see Add a Study Contact. This field does not appear on page layouts by default. Contact Veeva Support to enable this field in your Vault. Your Admin must then add it to the Inbox Item page layout. |
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. |
Case Identifier(s) (Case Identifier, Type, and Source) |
Enter the Case Identifier (Reference Number). This value will be referenced for duplicate detection. Select one of the following Type options:
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, the system populates the Source Data panel with the Case Identifier information. If it was imported from an E2B file, the system sets the Type to E2B Re-Transmittable. You can add up to 20 Case Identifiers. Note You cannot add two (2) Case Identifiers with the same ID and Source combination. |
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.
Field | Description |
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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.
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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. 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. Note If the Country entered has mapped domestic state codes, but the value entered in the State/Province field does not match a mapped value, an INVALID tag appears next to the field. Select a value from the picklist to update the State/Province to a valid value. |
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. |
If the Site Reporter field for Inbox Items is enabled in your Vault and this field is populated, the system uses the Site Reporter’s Country and Language to set the Inbox Item Localization.
When the Auto-select Inbox Item Localization by Reporter Country feature is enabled, for primary Reporter-type Contacts, if the Country has a Localization record, the Localization on the Inbox Item is automatically set based on the Reporter Country. The system maps the Localization based on the following criteria:
- If the Reporter Country is mapped to one language, that country and language are applied.
- If the Reporter Country is mapped to multiple languages, the system references the Reporter Language field of the Inbox Item.
- If a match is found, it is applied.
- If no match is found, the system checks for an English record.
- If no English record exists, the system applies the first Localization record in alphabetical order for that country.
Note If both the Auto-select Inbox Item Localization by Reporter Country feature and the Site Reporter field are enabled, the system uses the Site Reporter’s Country and Language to set the Inbox Item Localization.
Your Admin can also configure the system to set the Inbox Item Localization using both the Primary Reporter Country and Report Type.
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How the System Sets Inbox Item Localization Using Reporter Country and Report Type
When the Auto-select Inbox Item Localization by Reporter Country feature is enabled:
- If a match for the Primary Reporter Country and Report Type is found, the corresponding Localization value is set on the Inbox Item.
- If multiple matches for either the Primary Reporter Country or Report Type are found, the system references the Reporter Language field of the Inbox Item.
- If there is no Reporter Language, the system checks for an English record.
- If there are still multiple matches, the system applies the first Localization record for that Country or Report Type.
- If no matches are found for the Primary Reporter Country and Report Type, the Inbox Item Localization field is left blank.
If the Localization Type (on the Localization record) is Local, the Inbox Item is processed as a Domestic Case. If the Localization Type is Global, the Case is processed as a Global Case.
Note Although the Localization is applied automatically, the Localization field does not display the locale until you click into the field or save the Inbox Item. This is a known limitation that will be addressed in a future release.
Patient Section
Use the Patient section to capture information about the patient who experienced the adverse event.
Field | Description | ||||||||||||||||
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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. | ||||||||||||||||
Pregnancy Case | 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. To learn more, see Add a Pregnancy Case. This field does not appear on page layouts by default and must be added by your Admin. | ||||||||||||||||
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-CalculationWhen you promote to Case, the system automatically calculates this field using the time interval between the following dates:
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. |
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Age Group |
The patient's age group at the onset of the adverse event, according to the following criteria:
Auto-CalculationThe system automatically calculates the age group based on the value in the Age at Onset field and the above criteria. |
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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:
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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, along with their Product Registration and Drug History records are created according to the Product Type.
Considerations for the Products Section
Consider the following when working with the Products section:
When you add a product of the Company Product type, after promoting the Inbox Item to a Case, the Transmission Product Type from the Registered As field of the Product Registration is snapshotted to the Product Globally Registered As field. Available Transmission Product Types include the following:
- Drug
- Biologic
- Device
- Vaccine
- Nutritional
- Cosmetic
- OTC Drug
- OTC Device
- Combination Product
Your Vault may not be configured to display the Globally Registered As field, which is intended for Admin use only.- For manual Study report intake, the Products 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 populates that record Type as Case Product. You can edit this setting.
- You can also add Study Product records before promoting the Inbox Item to a Case.
- Depending on your Admin’s configuration, suspect Case Products may include those with a Drug Role of Drug Not Administered. See Enable Extend Definition of Suspect to Drug Not Administered for details.
Product Fields
Note If the Product Type is set to Drug History, you can specify only the Rank and Product fields.
Field | Description | ||||||||||||||
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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.
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Type |
(Required) This field allows you to classify the product as either:
Upon Case promotion, this classification determines whether this product becomes a Case Product or a Drug History record. |
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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:
For Device-type Case Products to appear on generated MedWatch 3500A reports, the Drug Role must be Interacting, Suspect, or Drug Not Administered. |
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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. The system populates this field based on the value entered in the Product field. To learn more, see Manage Products. | ||||||||||||||
Study Product |
This field appears for Inbox Item Study Cases. Select the Study Product name. Note This field does not appear for manual Inbox Items with armed Studies. |
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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. |
Add Study Products to Inbox Items
You can add Study Products to manual and imported Inbox Items to reduce effort during Case processing.
Ensure the following prerequisites are met:
- Your Admin must enable the Specify Study Products action on the Inbox Item page layout.
- The Inbox Item Report Type must be set to Study.
- The selected Study must meet the following criteria:
- The Study Type is set to Clinical Trial.
- Study Has Unspecified Products is set to No or blank.
The following steps describe how to add multiple Study Products to an Inbox Item:
- In the Products section, select the All Actions () menu and then select Specify Study Products. A Specify Study Products window appears.
- Select the Study Products you want to add to the Inbox Item.
You can toggle between Open and Unblinded Study Products and Blinded Study Products, or search for a specific one.
The Open/Unblinded tab displays all Study Products configured in the selected Study. The Blinded tab displays all Blinded Names configured in the selected Study.Note If your Inbox Item is newly created and has not been saved (for example, does not have an Inbox Item ID), you can select a maximum of ten (10) Study Product records.
- After selecting all the relevant Study Products, select Confirm.
Result
The system creates a record in the Products section for each specified Study Product.
If the Inbox Item does not contain a rank 1 Product yet, the system assigns the first Study Product as the primary. If there is already a rank 1 Product, the system sets the new Study Products to rank 2.
For Study Products selected from the Blinded tab (Study Product Placeholders), the system sets the Study Product field to Blinded. For Study Products selected from the Open/Unblinded tab, the system sets the Study Product field to Open Label. You can update this value if needed.
The system promotes all Product and Study Product records, including imported Product records from E2B intake, during Case promotion.
Note When you manually add Study Products to the Inbox Item, either by populating the Products section field or using the Specify Study Products action, the system does not promote the Study Arm Products associated with the selected Study Arm.
Dosage Fields
You can capture Dosage information for Case Product-type products.
You can also copy a Dosage record and any inputted data by selecting the Copy () icon. To mark a Dosage record for deletion, select the Delete () icon.
Note Inbox Items support up to 10 dosages per Product. Additional dosages can be added after Case promotion.
Field | Description |
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Dose | The amount of product administered at one time. Enter the (numeric) dose value in the first field. Select the unit of measure for the dose from the picklist, or create a custom entry. |
Frequency |
Enter how often the dose was administered. Once you save the page, the system will calculate and display an E2B-compliant description of the values. For example, 4 times per day (.25 days).
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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 an option from the picklist, or create 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 picklist, or create a custom entry. |
Dosage Text | Enter a description of the dosage when there is information that cannot be captured in the other Dosage fields. |
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.
Note If the Type is Medical History & Concurrent Conditions, you can only specify the Rank, Event, Onset, and Cessation fields.
Field | Description |
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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.
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Type |
(Required) This field allows you to classify the event as either:
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:
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