Enter Case Data

Vault generates a Case Number and populates this field when a Case is created.

You cannot edit this field. Outside of Edit mode, hovering over the Case Number link displays the UID and Worldwide UID.

This field appears when you hover over the Case Number.

The UID is a system-generated E2B-compliant unique identifier that is composed in the following format: {Country}-{Organization UID Code}-{Case Number}
where:

1. Country: The two-letter ISO country code for the Case country. Vault first attempts to use the Country on the primary Reporter-type Case Contact. If the reporter country is unavailable, Vault uses the Event Country on the primary Case Adverse Event.
   When the country being used for the UID changes, Vault automatically updates the UID to match the new country code. This behaviour only applies to initial Cases.
2. Organization UID Code: The value in the Organization UID Code field for the Organization associated with the Case, if available.
3. Case Number: Vault-generated value from the Case Case Number field.

• Country on the primary Case Adverse Event
• Country on the primary Reporter-type Case Contact

This field appears when you hover over the Case Number.

The worldwide unique case identification (WWUID) identifies an external safety case. For example, a previously submitted case received from an MAH or partner.

You can manually enter the Worldwide UID on an Inbox Item before promoting to a Case. Otherwise, Vault automatically populates the field upon Case promotion using the value in the Organization UID Code field for the Organization associated with the Case, if available.

(Required) The date the event was first reported. This date starts the regulatory clock in calculating expedited reporting (for example, 7-day or 15-day reports).

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

The Receipt Date entered on the Inbox Item becomes the Initial Receipt Date upon Case promotion.

This is a lookup field that appears for Follow-up Cases only. Because this is a lookup field, if the Receipt Date on the original Inbox Item changes after Case promotion, the audit trail on the referenced object does not reflect the change.

The latest date when additional information was received about the case.

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.

There can be only one New Info Date per Case version. If you overwrite this field with a new date, any previously recorded New Info Dates will appear in the audit trail.

(Required) The method in which the adverse event was reported by the primary source.

Select the appropriate report type.

Vault calculates the Case reporting due date and populates this field using the seriousness criteria, expectedness, and watchlist tags. If the Case is re-assessed and these criteria change, Vault automatically updates the due date based on the most conservative Regulatory or Partner due date.

For more information, see Reporting Rule Parameter Reference.

Vault automatically populates this field using causality assessments on primary Case Assessment Results.

For more information, see How Case Watchlist Tags and DMEs are Assigned.

The MedDRA Preferred Term (PT) coded on the primary Case Adverse Event.

If the Case Adverse Event has not been coded, this field is blank. This field dynamically updates to match the primary Case Adverse Event.

The level of impact the adverse event had on the patient.

Vault automatically populates this field using the most severe seriousness criteria entered on the primary Case Adverse Event.

Whether the primary Case Adverse Event matches to a term on the Datasheet for the Study, Product, or Product Family. Any MedDRA Lower Level Term is considered a match if it is listed on or falls under the hierarchy of the term on the Core Datasheet or Study Datasheet.

Vault populates this field using the Listedness (Core) value in the primary Case Assessment. To override Vault-calculated value, select a different option. Once overridden, Vault stops syncing the Case Listedness (Core) field with the primary Case Assessment.

For more information, see Manage Datasheets and Auto-Expectedness.

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

Whether the primary Case Adverse Event is expected. That is, whether the primary Case Adverse Event matches to a term on the relevant Product Family, Product, Local, Study, and Study Product Datasheets. Any MedDRA Lower Level Term is considered a match if it is listed on or falls under the hierarchy of the term on the Datasheet.

Vault populates this field using the Expected value in the primary Case Assessment. To override Vault-calculated value, select a different option. Once overridden, Vault stops syncing the Case Expectedness field with the primary Case Assessment.

For more information, see Manage Datasheets and Auto-Expectedness.

Vault automatically populates this field using causality assessments on primary Case Assessment Results.

For more information, see How Case Relatedness is Calculated.

Indicates whether the case requires expedited reporting.

Vault automatically sets this field to Yes (expedited) when one of the following conditions are met:

1. The Case has an adverse event that matches an expedited Watchlist.
2. The Case meets seriousness criteria and contains an unexpected adverse event (serious, unexpected case).
3. The Case contains both an adverse event that matches an expedited watchlist and an unexpected serious adverse event.

For more information, see How Case Watchlist Tags and DMEs are Assigned.

Enter any comments or additional information that should be populated in the 26. Remarks field on the CIOMS I form.

For more information, see CIOMS I Generation Data Mapping.

The calculated Validation Result for the Case.

The following list describes the Validation Status field values:

• Pass: No validation rule failures were found.
• Warning: At least one validation rule has failed to pass with a Warning status.
• Fail: At least one validation rule has failed to pass with a Fail status.
• Hard Fail: At least one validation rule has failed to pass with a Hard Fail status.

For more information, see Case and Submission Validation.

Select this field to prevent Vault from generating Submissions or including this Case in aggregate reporting.

This field can be used to track and monitor non-submittable cases (for example, pregnancy, invalid, or nullified cases).

For more information, see Suppress Submissions of a Case Version.

The source document for the report. Use the link in this field to navigate to the source document.

Vault populates this field automatically when a document is used to create the Case. Otherwise, you can select the document manually.

The Literature Review in Vault SafetyDocs that includes the source Literature Article for the Case.

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

This field is related to the Create Inbox Item from Literature Article feature in Vault SafetyDocs. For more information, see Create Inbox Items from Literature Articles.

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

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

This field is related to the Create Inbox Item from Literature Article feature in Vault SafetyDocs. For more information, see Create Inbox Items from Literature Articles.

The version of the source document. Use the link in this field to navigate to the source document.

Vault populates this field when you attach or create the Case from a source file.

Enter information to specify the reason why the case was received late.

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

Unique Identifier for an external system.

You can manually enter the External System UID on an Inbox Item before promoting to a Case or on the Case itself.

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

When a Follow-Up Case is created, the Initial Case field for this record is automatically populated with the original Case.

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

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

For more information, see Process Special Report Classification Cases.

Select from the following options in the picklist:

When you first generate the Transmission record, this value is copied to the Reason field of the Transmission.

Enter up to 2,000 characters to describe the reason for the amendment or nullification.

When you first generate the Transmission record, this value is copied to the Reason Text field of the Transmission.

The assigned Access Group based on the Case.

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

This field does not appear on layouts by default. Depending on your organization's security configuration, it may be added by your Admin.

Displays the format the Inbox Item was created from, such as an E2B file.

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

Displays the method of intake for the Inbox Item, such as Email.

Displays the number of Case copies created from the open Case.

Displays the market segment associated with the study for Study Cases or the primary Product for postmarket Cases.

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

Displays the reportability of the Case.

Vault sets this informational field when you execute one (1) of the following actions for the Case:

• Evaluate Regulatory Conformance
• Recalculate Due Date
• Evaluate Reporting Obligations

The field displays one (1) of the following values depending on the outcome of the executed action:

• Business Partner: The Case is reportable to a Business Partner only (Distribution).
• Health Authority: The Case is reportable to a Health Authority only (Submission).
• Health Authority & Business Partner: The Case is reportable to a Health Authority and a Business Partner (Submission and Distribution).
• Not Reportable: The Case is neither reportable to a Health Authority nor a Business Partner.

You can use this field to prioritize Cases.

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

The type of device report. Select one (1) or more of the following options:

• Malfunction
• Public Health Risk
• Product Problem
• Serious Injury

This field is automatically populated with "Malfunction" if the Malfunction field is set to Yes on any Combination Product Device Constituent or any Company Product with a Transmission Product Type of Device.

This field is set to "Auto-Calculated" when Vault Safety automatically populates the Device Report Type field based on the Case Product Device Malfunction fields.

When the Device Report Type field is manually edited, this field updates to "Overridden".

Manually editing this field from "Overridden" to "Auto-Calculated" causes Vault to recalculate the Device Report Type field.

This field is set to Yes when each of the following conditions are met:

• The Case Seriousness field is blank
• The Case Device Report Type contains Malfunction
• The Case adverse event MedDRA is either 10067482 (PT) or 10077536 (SOC)

Vault automatically populates this field, and it is read-only.

For malfunction-only cases, you can enter "None" in the Patient Initials field and leave all other patient information blank to transmit patient characteristics as None in FDA VAERS E2B R3.

The reasons for the follow-up on the device-type case.

Select the options that describe the reason for the follow-up. This field is not displayed for Initial Cases.

Whether remedial action was taken to address the adverse event.

If remedial action was taken, select the option that best describes the action or select Other to manually enter a text description.

Text description of the remedial action when there is no matching option in the picklist.

Enter a text description of the remedial action that was taken. You must set the Remedial Action field to "Other" for this field to appear and for text in this field to be exported on Transmissions.

The user who manually locked the Case from editing.

Vault automatically populates this field. Users with the appropriate permissions can use this field to reassign a locked Case or clear it to unlock the Case.

Depending on your Admin's configuration, this field name may display as Assigned To.

The date when the case was locked.

Vault automatically populates this field.

Indicates whether or not this Reporter record is the primary source.

If this contact is the primary Reporter, select Yes.

The contact's qualification.

Start typing for instant search or select the binoculars icon browse the available options.

Enter the contact's title.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.

Enter the contact's first name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.

Enter the contact's middle name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.

Enter the contact's last name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.

Enter the name of the facility.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the type of facility.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

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.

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.

Enter the contact's telephone number.

If the contact type is Reporter, Patient, or Facility, you can use the Reason Omitted field if the information is unavailable.

Enter the Reporter's email address. To send automatic questionnaire emails for follow-up information, both the Email Address and Email Consent Provided are required.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Indicates whether the Reporter has consented to receive emails.

Select this field if the contact has consented to receiving email notifications or requests for follow-up information.

For more information, see Send a Follow-Up Email Questionnaire to a Case Reporter.

Enter the contact's fax number.

If the contact type is Facility, you can use the Reason Omitted field if the information is unavailable.

Designates the contact as the best physician or other health care professional to contact about the adverse event.

If the contact is the best physician or health care professional to contact about the case, select the check box.

Indicates whether or not the case has already been reported to the FDA.

If the report has been sent to the FDA, select Yes.

Enter any relevant additional information about the Reporter.

Source of the FDA 3500A report.

Use the drop-down list to choose a value.

Enter any additional information that cannot be captured in the other contact fields. This field appears for Health Care Professional Case Contacts only.

Indicates whether the facility has a military designation.

If the facility is a military facility, select Yes.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

To order the list of Reporters by rank, enter the rank number. Ranked records appear in ascending order on the Case and in generated ICSR documents.

Reporters ranked as 1 correspond to the primary Reporter role. If you change a Reporter to rank 1, Vault updates the rank of the previous primary Reporter to 2.

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

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.

Use this field to enter the second line of the street address.

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.

Enter the county where the contact resides.

Enter the state or province where the contact resides.

If the state or province is mapped to a domestic state code on a Country State/Province record, a picklist is available based on the Country entered. This is useful for domestic cases originating in a country, such as Spain or Italy, where the state code is required in submissions to a specific agency, such as the EMA.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

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.

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.

Additional related patient pregnancy information.

Enter any additional information related to Case or Patient pregnancy.

The NMPA Report Classification for Chinese Cases.

Select the appropriate NMPA Report Classification for the report from the dropdown menu.

This field is only available when you select "Other Health Professional" for the reporter qualification on the Case.

Select the qualification of the reporting health professional contact from the dropdown menu.

This field is only available for studies.

Select the appropriate MFDS Study Type Classification for a study from the dropdown menu.

This field is required for Cases with post-market products.

Select the origin of the report from the dropdown menu.

Select the patient's race for Chinese NMPA Cases.

Select the NMPA patient race from the dropdown menu.

The patient's nationality code for Chinese NMPA cases.

Enter the Chinese nationality code for the patient in the text format "XX". This field is required.

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.

Whether there is a known Patient involved in the Case. This information is required for reporting obligations in certain jurisdictions.

Select this field if any of the following scenarios apply:

• There is a referenced patient in the Case
• There is a patient, but specific patient characteristics are not available
• There is a patient, but the patient may not be identifiable

For more information, see Reporting Rule Parameter Reference.

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

Enter the patient's initials.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's name prefix or title. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's first name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's middle name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's last name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The unique Subject/Patient ID, Centre ID, or random number in a clinical trial.

If a clinical trial investigated the adverse event, enter the following information:

• The patient's medical record number with a general practitioner
• The general practitioner's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's randomization number from the clinical trial randomization system.

Vault can automatically populate this field during a bulk unblind operation using the study participants CSV file. You can also enter this field manually.

For more information, see Bulk Unblind a Study.

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

Select the patient's sex. Depending on your Admin's configuration, this field may be labeled Gender.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the patient's gender identity or enter a custom value of up to 100 characters.

The patient's height.

In the first field, enter a number. In the second field, select the unit of measurement.

Enter the patient's weight.

In the first field, enter a numeric value. In the second field, select the unit of measurement.

Reference to the Parent Information Case from the current (child) case. The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.

For a parent-child case, create or select the Parental Case to link it to the current Case. You must select a Case with the object type of Parental Case (parental_case__v). For more information, see Add a Parental Case.

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.

The normalized Age at Onset value calculated in "years".

Vault automatically calculates Age (normalized) and uses it to populate the Age at Onset field, if no value exists already.

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

Vault 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, Vault uses the Case Receipt Date.
   Note If there are multiple Case Adverse Events, Vault uses the earliest event to calculate the age. For fetal adverse events, Vault uses the event closest to the birth date.

If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit one of the above fields used in auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

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.

For more information, see How Age Fields are Calculated.

The patient's age at the onset of the adverse event.

This field is populated by Vault-calculated Age (normalized) field. Vault automatically populates this field upon Case promotion or when the Case is updated. You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

The age value displays the patient's current age in years. For example, if the patient's age at onset is 53 years and nine months, Vault will display 53 years old in the Age at Onset field.

If the patient is less than two years old, Vault displays the patient's current age in months. For example, if the patient's age at onset is 50 days old, Vault will display the patient's age as 1 month old in the Age at Onset field.

For more information, see How Age Fields are Calculated.

The patient's age group at the onset of the adverse event, according to the following criteria:

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.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

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

For more information, see How Age Fields are Calculated.

The patient's age at the time of being administered the primary vaccine-type product. This field is used in FDA VAERS reporting.

Vault automatically calculates this field upon Case promotion or when the Case is updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

Vault automatically calculates this field when the primary Case Product is a Vaccine-type product. The age at vaccination is calculated using the time interval between the following dates:

1. The Case Date of Birth
2. The primary Vaccine-type Case Product Dosage First Admin Date

   If there are multiple Dosages under the primary Vaccine-type Case Product, Vault uses the earliest First Admin Date to calculate the age.

Indicates whether or not an autopsy was performed. This field displays if the Date of Death field has a value.

Select either Yes or No from the drop-down menu.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

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.

Enter the date when the patient last experienced a menstrual period. This field is available only if the Sex field is set to Female.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Use this field to identify a case as a Pregnancy Case for tracking and capturing pregnancy information. This field is available only if the Sex field is set to Female.

For more information, see Process Pregnancy, Child Information, and Parent Information Cases.

Indicates whether the patient was pregnant at the time of exposure. This field is available only if the Sex field is set to Female. This field is used in FDA VAERS reporting.

If the patient was pregnant at the time of exposure, select Yes.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the patient's ethnicity. Start typing for instant search or use the binoculars icon to browse for the appropriate value. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the patient's race from the drop-down list. This field is used in FDA VAERS reporting.

The patient's medical record number with a specialist and the specialist's record number.

If the patient visited a specialist for the adverse event, enter the following information:

• The patient's medical record number with a specialist
• The specialist's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's medical record number with a hospital and the hospital's record number.

If the patient visited a hospital for the adverse event, enter the following information:

• The patient's medical record number with a hospital
• The hospital's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's medical record number with a general practitioner and the general practitioner's record number.

If the patient visited a general practitioner for the adverse event, enter the following information:

• The patient's medical record number with a general practitioner
• The general practitioner's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select Yes or No to indicate whether the patient was being treated with concomitant therapies, such as radiotherapy, drug class, or dietary supplements, at the onset of the adverse event.

The patient's military status type. This field is used in FDA VAERS reporting.

Enter the patient's medical history and concurrent conditions, which could not be coded as Medical History records. If there is no medical history, you can specify "None."

If the source report omits the medical history, select the option that describes why this information is not available.

Reference link to the Case.

Vault automatically populates this field.

Select the Study that the Study Product is associated with. Vault automatically populates this field with the Study associated with the Case. This field appears for Study Products only.

For more information, see Manage Studies.

Indicates whether the product is the primary product on the Case.

If the product is the key suspect product of interest, Select Yes. You cannot make an External Product primary.

To order Case Products by rank, enter the rank number.

Products ranked as 1 correspond to the primary product role.

If you change a product to rank 1, Vault updates the rank of the previous primary product to 2. Ranked records appear in ascending order on the Case and in generated ICSR documents.

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

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

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

Enter the name of the product, as reported by the source. For information on coding products based on the reported Product, see Auto-Code and Browse Products.

When adding unblinded or open label Study Products to a Case, if the Product (Reported) field is blank, Vault maps the Study Product Name to this field. When adding blinded Study Products to blinded Cases, Vault maps the blinded product name from the applicable Study Product Placeholder record. When adding non-blinded Study Products to blinded Cases, Vault populates the value from the Product (Coded) field. Vault does not override the field if it is populated.

A link to the Product, as configured in the Product Library .

Select the Product from the drop-down menu. The options are filtered by the Products in the Product Library under the Case Organization.

For more information, see Manage Products.

The combination product for which this product is a product constituent. This field appears for Combination Product Constituents only.

Vault automatically populates this field when a Combination Product was selected as the product in the source Inbox Item.

When adding or editing a Product record to include a Combination Product, related constituent Products are automatically downloaded and added as separate Case Products.

For more information, see Manage Combination Products.

The brand name of the device.

For Device-type products, this field is used in report generation for FDA E2B(R2) (B.4.k.20.FDA.1).

For devices only, enter the product code classification.

The type of vaccine. This field is used in FDA VAERS reporting.

The following options are available by default:

• Live Attenuated Viral
• Inactivated
• Subunit
• Toxoid

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

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.

For more information, see Add Product Registration Details.

A link to the Combination 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.

For more information, see Combination Product Registrations.

Select the country where the product was obtained.

Product code from the WHODrug dictionary. This field appears for External Products only. Vault populates this field only when the External Product is selected through the WHODrug Browser.

For information on browsing and coding terms from the WHODrug dictionary, see Code WHODrug Products.

Product code from the Japan Drug Dictionary (JDD). This field appears for External Products on Domestic Cases for Japan only.

For information on browsing and coding terms from the JDD, see Code Japan Drug Dictionary Products.

Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code.

This field is automatically populated based on the selection from the WHODrug dictionary.

The WHODrug version for the MPID. This field appears after coding the WHODrug product code.

This field is automatically populated based on the selection from the WHODrug dictionary.

Select what action was taken with the product as a result of the adverse event. Use the binoculars icon to search for Action Taken or enter the information manually.

Whether remedial action was taken to address the adverse event.

If remedial action was taken, select the options that describe the actions. The following options are available by default:

This field populates the applicable H7. If Remedial Action Initiated, Check Type checkboxes in the FDA 3500A form.

Text description of the remedial action when there is no matching option in the picklist.

Enter a text description of the remedial action that was taken. You must include "Other" in the Remedial Action field for text in this field to be exported on Transmissions.

This field populates the H7. If Remedial Action Initiated, Check Type > Other field in the FDA 3500A form.

Whether the device failed to meet its performance specifications or otherwise perform as intended.

Select Yes or No from the picklist.

When this field is set to Yes on at least one device, Vault automatically sets the Case Device Report Type field in the Device Details section to “Malfunction”.

Based on the primary Case Device Product, this field populates the H1. Malfunction checkbox in the FDA 3500A form.

The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.

Enter the gestational age at the time of the earliest exposure. Enter a numeric value in the first field and select a unit of time in the second field.

Additional information relevant to the product and its usage.

If there is additional information relevant to the product and its usage, select an option from the list.

If you cannot describe the additional information with any of these options, type the text in the Other Additional Information field.

If none of the options in the Additional Information list apply, use this field to enter any additional product information.

The product expiry date.

If Expiration Date is available, use the calendar tool to select the date or enter the date manually.

The original Expiration Date field does not accept partial dates. However, the Expiration Date control, introduced in the 22R1 release, accepts partial dates with a minimum precision of the year.

The total cumulative dose administered until the first sign of an adverse event.

Vault automatically calculates this field when you add or update information about the product dosage or onset of the earliest adverse event.

If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

For more information, see How Cumulative Dose is Calculated.

Select the product type for the external product to ensure product fields specific to product types are displayed. For example, certain fields only appear when you select Vaccine as the External Product Type. This field appears for External-type Case Products only.

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

Displays the Transmission Product Type in the Registered As field on the Product Registration. The options include the following:

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

Vault populates this field automatically using the Blinded Name (Study Product Placeholder) from the Inbox Item Study Product field.

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

Identifies whether a Clinical Trial Study Case Product is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product records, links to the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

The amount of product administered at one time.

Enter the (numeric) dose value in the first field. Select the Unit of Measurement for the dose from the picklist, or create a custom entry.

Enter how often the dose was administered. Once you save the page, Vault will calculate and display an E2B-compliant description of the values. For example, 4 times per day (.25 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 took 100mg of a drug in total, you should enter 100mg in the Dose field and select "Total" in the Frequency field.

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.

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.

Combined number and unit field to capture the overall duration of time that the product was administered to the patient.

Vault automatically calculates this field once you save the Case Product Dosage, based on the values in the following fields:

• First Admin Date
• Last Admin Date

Vault recalculates and updates this field any time the First Admin Date or Last Admin Date values are updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

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.

The product expiry date for the batch/lot number.

If Expiration Date is available, use the calendar tool to select the date or enter the date manually.

Description of the pharmaceutical Dose Form.

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.

Route of Administration code for the patient.

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

Route of Administration code for the parent for a parent-child or fetus report.

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

The facility where the vaccine was administered. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.

If the product is a vaccine, select the facility that administered the dosage. The options available in this list correspond to the Facility-type Case Contacts added to the Case.

The vaccine anatomical approach site. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.

Select the anatomical site to which the dosage was administered.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the dose number in the series. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.

Enter a description of the dosage when there is information that cannot be captured in the other Dosage fields.

Identifies whether a Clinical Trial Study Case Product Dosage is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product Dosage records, references the associated blinded record if available.

For more information, see Isolate Blinded Clinical Trial Information.

The indication for product use.

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 MedDRA term and code appear below the field.

For more information, see Code MedDRA Terms.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The reason an indication was omitted.

Select the reason for omitting the reported indication, when applicable.

Selecting a nullFlavor automatically codes the MedDRA term "Drug use for unknown indication (10057097)” below the Indication (Reported) field.

Identifies whether a Clinical Trial Study Case Product Indication is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product Indication records, references the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

Enter the model number assigned to the medical device by the manufacturer.

Enter the catalog number assigned to the medical device by the manufacturer.

Enter the lot number assigned to the medical device by the manufacturer.

Enter the serial number assigned to the medical device by the manufacturer.

Enter the unique identification code assigned to the medical device by the manufacturer.

The operator using the medical device.

Select the type of operator from the picklist. By default, the options in this picklist are:

• Health Professional
• Lay Person
• Other

You must select Other in the Operator of Device field for this field to appear.

Enter a text description of the medical device operator if the Operator of Device picklist does not contain a suitable option.

Select Yes or No to indicate whether the medical device is labeled for single use.

Select Yes or No to indicate whether the single-use medical device was reprocessed and used for a subsequent application. This field populates box 7b. in the FDA 3500A form.

Enter the name and contact information of the contact who reprocessed the medical device. This field populates box 7b. in the FDA 3500A form.

Enter the date when the medical device was implanted in the patient.

Enter the date when the medical device was removed from the patient.

Enter the date when the medical device was returned to the manufacturer.

Select Yes or No to indicate whether the device is available for further evaluation.

Select Yes, No, or Not Returned to Manufacturer to indicate whether the device has been evaluated by the manufacturer. This field populates Section H Box 3. Device Evaluated by Manufacturer on the FDA 3500A form.

Enter the date when the device was manufactured.

The product usage type for the device-type product.

Use the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.

The age of the device.

In the first field, enter a numeric value. In the second field, select a unit of time from the drop-down menu.

Enter the correction/removal reporting number. This must follow the format directed by 21 CFR 807. If you do not have a correction/removal reporting number, the FDA-assigned recall number can be entered.

This field populates Section H Box 9. If action reported to FDA under 21 USC 360i(f), list correction/removal reporting number on the FDA 3500A form.

Select whether the device was ever serviced by a third-party servicer.

Enter any additional information, evaluation, or clarification of information previously entered.

This field populates Section H Box 10. Additional Manufacturer Narrative on the FDA 3500A form.

The device for which you want to assign a problem code.

Select the binoculars icon to search for the device or start typing for instant search.

Displays the seven IMDRF annex names for the categories of device codes.

Select an option from the picklist.

After the Device Code Type field is populated, search for and select the device code from the picklist. The available options are dependent on the Device Code Type selected and the active IMDRF dictionary version.

Identifies whether a Clinical Trial Study Case Device-type Product is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product Device Code records, references the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

The device problem code. The Device Problem codelist is compliant with the FDA DPC code type.

For a medical device problem, select the device problem code.

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.

The device evaluation method code. The Evaluation Method codelist is compliant with the FDA EMC code type.

If the device was evaluated by the manufacturer, select the manufacturer evaluation method code.

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.

The manufacturer evaluation result code. The Evaluation Result codelist is compliant with the FDA ERC code type.

If the device was evaluated by the manufacturer, select the manufacturer evaluation result code.

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.

The manufacturer evaluation conclusion code. The Evaluation Conclusion codelist is compliant with the FDA ECC code type.

If the device was evaluated by the manufacturer, select the manufacturer evaluation conclusion code.

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.

Indicates whether blinding is enabled on the Study associated with the Case Product.

Vault automatically populates this field.

Indicates whether blinding is enabled on the Case.

Vault automatically populates this field.

Indicates whether Blind Protection is active for the Study Product. While a Case is blinded, the value in this field is blank. Blind protection becomes active after unblinding the Case.

Vault automatically populates this field.

For more information, see Manage Case Blinding.

Indicates whether the Study Product is currently blinded, unblinded, or open label.

Vault automatically populates this field.

The values that appear in this field depend on your Admin's configuration.

Also, depending on your Admin's configuration, this field's label may display as Blinded.

For more information, see Enable Product Masking Selection for Study Products.

The Product reference to which this Product Registration applies.

Vault automatically populates this field. By default, this field only appears for open or single-blinded Study Products.

The Case Product record type.

Vault automatically populates this field, and it is read-only.

Enter the product authorization or application number for the country where the product is marketed.

For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

Enter the name of the product license holder or applicant for the product license.

This value is populated from the Registration Holder/Applicant field from the Product Registration record. If this field is blank, this value is snapshot from the Organization field of the Product Registration.

If the product is a compounded product, specify the type. Start typing for instant search or select the binoculars to browse all available options.

Enter the Medicinal Product Identifier (MPID) for the product. Note that you can specify only one type of product identifier. Do not specify a MPID if you have entered a PhPID.

Enter the version date or number for the Medicinal Product Identifier (MPID).

If an admin has configured a Product Registration, select the appropriate Product Registration, and then save the page. Fields preconfigured on the Product Registration are automatically populated on the Case Product Registration upon saving. By default, this field only appears for open or single-blinded Study Products.

The product name from the product registration.

If the Product Registration Name is available, Vault Safety automatically populates this field using that name. Otherwise, this field is populated with the Product Name. If the Product is part of a blinded Study, the value in this field is blinded.

Select the country where the product is registered and authorized. This field is required when there is a value in the Registration Number field.

If the product is a combination product, select the combination type. This field is used in FDA VAERS reporting.

Enter the Pharmaceutical Product Identifier (PhPID). Note that you can specify only one type of product identifier. Do not specify a PhPID if you have entered a MPID.

Enter the version date or number for the Pharmaceutical Product Identifier (PhPID)

Enter the product container, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the qualifiers in the name for devices. This field is used in EMA reporting.

Enter the pharmaceutical form, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the product name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Enter the common product or scientific name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Enter the strength of the product, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the trademark or company, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the intended use of the product, if present in the Medicinal Product Name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Enter the Name of the Case Product Registration.

Identifies whether a Clinical Trial Study Case Product Registration is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

When the Product Registration is selected, Vault populates the Registration Country from the record in the Product Library .

For more information, see Isolate Blinded Clinical Trial Information.

Select a PMDA Product Registration from the dropdown menu. Product registrations are created when you configure the Product.

To order Case Products by rank, enter the rank number. Products ranked as 1 correspond to the primary product role. If you change a product to rank 1, Vault updates the rank of the previous primary product to 2. Ranked records appear in descending order on the Case and in generated ICSR documents. This field does not appear on layouts by default and must be added by an Admin to appear.

Vault populates this field with the earliest regulatory due date for this Case Product Registration. This is calculated based on the earliest Localized Case Assessment Due Date if one exists. If no Localized Case Assessment associated with this Case Product Registration has a Due Date populated, this field is left bank.

Vault calculates this value for the Case Product Registration based on the most conservative Localized Case Assessment.

Reference to the grandparent Case.

Vault automatically populates this field.

Reference to the parent Case Product.

Vault automatically populates this field.

Enter the substance name, as reported.

The substance strength. If the strength is a range, enter the lowest number in the range.

In the first field, enter the number. In the second field, select the Unit of Measurement.

Enter the substance Term ID.

Enter the substance Term ID Version or Version Date.

Identifies whether a Clinical Trial Study Case Product Substance is blinded.

Vault sets this to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

This field is always blank.

Reference link to the Case.

Vault automatically populates this field.

Indicates the primary adverse event for this report.

Select Yes if the adverse event is the reason for reporting the case or is most likely linked to the suspect product.

To order Case Adverse Events by rank, enter the rank number.

Adverse events ranked as 1 correspond to the primary adverse event role.

If you change an adverse event to rank 1, Vault updates the rank of the previous primary adverse event to 2. Ranked records appear in ascending order on the Case and in generated ICSR documents.

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.

The Common Terminology Criteria for Adverse Events (CTCAE) grade for adverse events affecting cancer patients.

For adverse events affecting cancer patients, select the CTCAE grade from the drop-down menu.

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.

The language that the primary source reported the event description in, if other than English.

Use the binoculars icon to search for the language corresponding with the adverse event or enter the language manually.

Select the country where the adverse event occurred. Use the binoculars icon to search for the country or start typing for instant search.

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.

If you select "Masked" as the Reason Omitted, the Reaction Onset is masked on the CIOMS I form. For more information, see CIOMS I Generation Data Mapping.

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.

The overall duration of time that the patient experienced the adverse event.

Vault automatically calculates this field once you save the Case Adverse Event, based on the time interval between the following dates:

• Onset
• Cessation

Vault recalculates and updates this field any time the above field values are updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

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.

Indicates whether a healthcare professional confirmed the adverse event.

Vault automatically populates this field for the primary adverse event, based on the Reporter Qualification specified on the initial Inbox Item. Otherwise, you can enter the value manually.

Indicates whether the adverse event is a symptom or a diagnosis.

To designate the adverse event as a symptom or a diagnosis, select an option from the list.

To associate an adverse event symptom to a diagnosis, select the Case Diagnosis.

To appear in this list, a medical reviewer must have already entered the Case Diagnosis. The Case Diagnoses section provides instructions.

Vault automatically populates this field when a Case Adverse Event matches one or more configured watchlists.

For more information, see How Case Watchlist Tags and DMEs are Assigned.

Indicates if the adverse event MedDRA PT matches a Designated Medical Event (DME).

Vault automatically populates this field when the adverse event MedDRA PT matches a Designated Medical Event (DME). The suspect product must be registered in the European Union for the adverse event to qualify as a DME.

For more information, see How Case Watchlist Tags and DMEs are Assigned.

Select the patient outcome with respect to hospitalization. This is required for FDA VAERS reporting when the Case Adverse Event Seriousness is set to "Caused / Prolonged Hospitalization".

• Hospitalization (FDA.E.i.3.2c.1)
• Prolongation of Hospitalization (FDA.E.i.3.2c.2)

Select the type of facility the patient was evaluated or treated at:

• Doctor/healthcare professional Office (FDA.E.i.3.3a)
• Emergency Department or urgent care (FDA.E.i.3.3b)
• Blank (FDA.E.i.3.2g)

This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The date the patient was admitted into the hospital.

Use the calendar pop-up tool or enter the date manually.

The patient was discharged from the hospital.

Use the calendar pop-up tool or enter the date manually.

Enter the number of days the patient was hospitalized. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the name of the hospital. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the city where the hospital is located. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the state where the hospital is located. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Reference link to the Case.

The MedDRA term for the case diagnosis.

Enter the 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.

For more information, see Code MedDRA Terms.

Captures a text description of the diagnosis or reclassification of the adverse event.

This field is not currently supported for E2B import or export or any type of report generation.

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

Reference link to the Case.

Vault automatically populates this field.

Reference link to the Case Product.

Vault automatically populates this field with the Case Product this assessment is evaluating.

Reference link to the Case Adverse Event.

Vault automatically populates this field with the Case Adverse Event this assessment is evaluating.

Whether the associated Case Adverse Event matches to an Expected term on Datasheets associated with the suspect Case Product or associated Study or Study Products. Any MedDRA Lower Level Term is considered a match if it is listed on or falls under the hierarchy of the term on the Datasheet.

If your Admin has configured Datasheets, Vault populates this field based on the expected reactions listed on the Datasheets. You can select a different option to override Vault-calculated value or to enter the value manually. Vault uses this value from the primary Case Assessment to populate the Case Expectedness field.

For more information, see Manage Datasheets and Auto-Expectedness.

How the Expected field was populated, whether system-calculated or with a manual override. By default, users in the Intake and Data Entry roles cannot edit this field.

Vault automatically populates this field.

Whether the associated Case Adverse Event matches to a term on the Datasheet for the Study or Product. Any MedDRA Lower Level Term is considered a match if it is listed on or falls under the hierarchy of the term on the Core Datasheet.

If your Admin has configured Datasheets, Vault populates this field based on the expected reactions listed on the Datasheets. You can select a different option to override Vault-calculated value or to enter the value manually. Vault uses this value from the primary Case Assessment to populate the Case Listedness (Core) field.

For more information, see Manage Datasheets and Auto-Expectedness.

How the Listedness (Core) field was populated, whether system-calculated or with a manual override. By default, users in the Intake and Data Entry roles cannot edit this field.

Vault automatically populates this field.

Select the option that best describes whether the adverse event recurred.

Note that the option "no - n/a (no rechallenge was done, recurrence is not applicable)" is equivalent to a dechallenge. You can capture the dechallenge details, such as positive or negative, in the case narrative.

The time interval between the first administered dose of the product and when the adverse event started.

Vault automatically calculates the first dose latency, based on the time interval between the following dates:

• The First Admin Date field on the Case Product Dosage
• The Onset field on the Case Adverse Event

Vault recalculates and updates this field any time the Onset or First Admin Date values are updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

For more information, see How Dose Latency is Calculated.

The time interval between the last administered dose of the product and when the adverse event started.

Vault automatically calculates the last dose latency, based on the time interval between the following dates:

• The Last Admin Date field on the Case Product Dosage
• The Onset field on the Case Adverse Event

Vault recalculates and updates this field any time the Onset or Last Admin Date values are updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

For more information, see How Dose Latency is Calculated.

Ranked assessments are listed in ascending order on the Case.

To order the list of assessments by rank, enter the rank number. The rank of 1 is reserved for the assessment on the primary adverse event and primary product.

Vault automatically tags Case Assessments as SUSAR or SAE when the appropriate criteria is met:

• SUSAR: When a Study Case Assessment for a Serious, Unexpected Adverse Event paired with a Suspect, Interacting, or Drug Not Administered company Product is assessed as related:
  1. The Case Product associated with the Assessment must be Suspect, Interacting, or Drug Not Administered. (The Case Product > Drug Role (drug_role__v) field is set to Suspect, Interacting, or Drug Not Administered.)
  2. The Case Adverse Event associated with the Assessment must be Serious. (A value is entered in the Case Adverse Event > Seriousness (seriousness__v) field.)
  3. The Expectedness field on the Assessment is set to No or is blank.
  4. The Assessment has at least one Assessment Result with the Causality Established field set to Yes.
• SAE: When a Case Assessment contains a Serious Adverse Event paired with a Suspect, Interacting, or Drug Not Administered company Product:
  1. The Case Product associated with the Assessment must be Suspect, Interacting, or Drug Not Administered. (The Case Product > Drug Role (drug_role__v) field is set to Suspect, Interacting, or Drug Not Administered.)
  2. The Case Product associated with the Assessment must be selected from the Product Library (for example, Case Product > Product is selected) or a Study Product.
  3. The Case Adverse Event associated with the Assessment must be Serious. (A value is entered in the Case Adverse Event > Seriousness (seriousness__v) field.)

If neither of the above criteria are met, then the Assessment Tags field is left blank.

Identifies whether a Clinical Trial Study Case Assessment is blinded.

This can be set to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Assessment records, links to the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

The name of the Expectedness record.

Vault automatically populates this field for system-generated Expectedness.

A link to the Datasheet configured in Business Admin.

To view the Datasheet record, select the link.

For more information, see Manage Datasheets and Auto-Expectedness.

The associated datasheet document from the Vault Library.

To view the datasheet Vault document, select the link.

For Local Datasheets, the country to which the datasheet applies. When evaluating reporting rules, Vault uses Local Datasheets within the jurisdiction of the target agency to evaluate the Expectedness rule parameter.

Vault automatically populates this field for system-generated Expectedness.

For more information, see Reporting Rule Parameter Reference.

Indicates whether the Case Adverse Event MedDRA matches to a term on the referenced Datasheet. Any MedDRA Lower Level Term is considered a match if it is listed on or falls under the hierarchy of the term on the Datasheet.

Vault automatically populates this field for system-generated Expectedness.

For more information, see Manage Datasheets and Auto-Expectedness.

How the Expected field was populated, whether system-calculated or with a manual override.

Vault automatically populates this field for system-generated Expectedness.

For Clinical Trial Study Cases, identifies whether Vault calculated expectedness based on the Onset date of Adverse Events or the New Info Date on the Case.

For more information, see how Vault calculates expectedness for Clinical Trial Study Cases based on Agency settings in How Case Assessment Expectedness is Generated.

When Vault evaluates the Expected value for an Adverse Event based on the applicable Datasheet, Vault populates the value from the Expectedness Justification field for the Adverse Event on the Datasheet. You can enter or edit the value in this field, using up to 1,000 characters.

For all Cases reportable to Localizations that do not have Localized Assessments for Case Product Registrations in the Assessment Generation field, Vault maps this value to related Localized Case Assessments.

Identifies whether a Clinical Trial Study Case Assessment Expectedness is blinded.

This can be set to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product Assessment Expectedness records, references the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

Reference link to the Case.

Vault automatically populates this field.

Reference link to the Case Assessment.

Vault automatically populates this field.

Description of the source of the assessment, such as Sponsor, Investigator, or Health Care Professional.

For auto-generated Case Assessment Results, Vault automatically populates the Source Type as follows:

• Company's Assessment: The Source Type is set to Sponsor or MAH.
• Reporter's Assessment: The Source Type is set to one of the following, based on the Report Type and the Reporter Qualification specified on the primary Reporter-type Case Contact:
  • Investigator
  • Health Care Professional
  • Non-Health Care Professional

For more information, see About Generating Assessments.

If you cannot capture the source using an option from the Source Type list, use this field to enter a free text description of the source.

Select the option that best describes the method of assessing the case.

If you cannot capture the assessment method using an option from the Method of Assessment list, use this field to enter a free text description of the method.

Describes the result of the Case Assessment. Vault may populate this field or you can select an option.

(Optional) An Admin must add this field to the Case layout.
If you select a value for this field, Vault uses this value instead of the Assessment Result value when generating an E2B document or a CIOMS I Transmission or preview. Contact Veeva Support to request this feature be made available in your Vault.

If you cannot capture the assessment result using an option from the Assessment Result list, use this field to enter a free text description of the result.

Indicates whether the adverse event causality has been established with respect to the suspect product.

The value in this field from the primary Case Assessment Results to populate the Case Relatedness. If this is set to Yes on any primary Case Assessment Result, the Case Relatedness is set to Yes.

Vault automatically populates this field.

For more information, see How Case Relatedness is Calculated.

Identifies whether a Clinical Trial Study Case Assessment Result is blinded.

This can be set to one (1) of the following:

For more information, see Isolate Blinded Clinical Trial Information.

For unblinded Clinical Trial Study Case Product Assessment Result records, references the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

Reference link to the Case.

Vault automatically populates this field.

The reported term and MedDRA term for the cause of death.

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

For more information, see Code MedDRA Terms.

Reference link to the Case.

Vault automatically populates this field.

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

For more information, see Code MedDRA Terms.

Use the calendar pop-up tool to select a date or enter the date manually.

The date when the medical condition started.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select Yes or No to indicate whether the medical condition is currently ongoing.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The date when the medical condition stopped.

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.

Select Yes or No to indicate whether another family member experienced the same medical condition.

Select Yes or No to indicate whether the illness, condition, or symptom was present at or about the time of vaccination.

Enter any additional relevant information about the medical condition.

Reference link to the Case.

Vault automatically populates this field.

Enter the name of the product, as reported by the source.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Product code from the WHODrug dictionary.

After entering the reported drug name, select Search WHODrug to automatically populate the search query. Browse and select the appropriate product code using the WHODrug search window.

For more information, see Code WHODrug Products.

Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code.

This field is automatically populated based on the selection from the WHODrug dictionary.

The WHODrug version for the MPID. This field appears after coding the WHODrug product code.

This field is automatically populated based on the selection from the WHODrug dictionary.

Use the calendar pop-up tool to select a date or enter the date manually.

The date and time 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.

The date and time when the product was last administered.

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.

The MedDRA LLT for the drug history product use indication.

Enter the 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.

For more information, see Code MedDRA Terms.

Captures a text description of the drug history product use indication.

This field is not currently supported for E2B import or export or any type of report generation.

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

The MedDRA LLT for the reaction to the drug history product.

Enter the 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.

For more information, see Code MedDRA Terms.

Captures a text description of the reaction to the drug history product.

This field is not currently supported for E2B import or export or any type of report generation.

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

The age of the patient at the time of vaccination. This field is used in FDA VAERS reporting.

Vault recalculates and updates this field any time a field used to calculate this value is updated. If you manually enter a value after the auto-calculation, Vault retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, Vault will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.

Vault automatically calculates this field for vaccine-type products. The age at vaccination is calculated using the time interval between the following dates:

1. The Case Date of Birth field
2. The Case Drug History Start Date field
   The Product Type field on the Drug History record must be set to Vaccine. If you do not see this field, an Admin must add it to the layout.

Enter the product name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Enter the common product or scientific name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Enter the trademark or company, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the strength of the product, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the pharmaceutical form, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the product container, if present in the Medicinal Product Name. This field is used in EMA reporting.

Enter the qualifiers in the name for devices. This field is used in EMA reporting.

Enter the intended use of the product, if present in the Medicinal Product Name without the trademark or the Marketing Authorization Holder (MAH), or any other descriptor in the product name. This field is used in EMA reporting.

Reference link to the grandparent Case.

Vault automatically populates this field.

Reference link to the parent Case Drug History.

Vault automatically populates this field.

The substance strength. If the strength is a range, enter the lowest number in the range.

Select the substance unit of measurement.

Enter the substance name, as reported.

Enter the substance Term ID.

Enter the substance Term ID Version or Version Date.

Reference link to the Case.

Vault populates this field.

The reported term and MedDRA term for the test performed.

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

For more information, see Code MedDRA Terms.

Date and time (if available) when the test or procedure was performed.

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.

Optionally, enter a qualifier, such as "Less than" (<). In the Number field, enter the value for the test result. In the Unit field, select the test result unit of measurement from the picklist, or use a custom entry.

When you enter a custom unit of measurement, the unit also appears in the Result (Unit) Text field.

Enter a description of the test result.

Enter a description of the test result unit.

This field is automatically populated if a custom unit of measurement is entered in the Test Result (Unit) field.

Code to describe the test result.

Select one of the following options from the picklist:

• Positive
• Negative
• Borderline
• Inconclusive

Enter the highest value in the normal range for the test. This value is usually published by the laboratory providing the test result.

Enter the lowest value in the normal range for the test. This value is usually published by the laboratory providing the test result.

Enter any relevant comments from the reporter about the test result.

Select Yes or No to indicate whether the sender has more information about the test result.

Vault automatically populates this field with a link to the narrative document, which is generated when you create the Case. To open the narrative document, select the link.

For more information, see Compose a Case Narrative.

This field is read-only and automatically updated with a text excerpt of the narrative document, up to 32,000 characters. This field shows a preview of the narrative that will be populated in generated regulatory reports. To update the narrative, edit the narrative document.

When blind protection is active, this field is prepended with [Blind Protection].

Enter the company's assessment of the case, which can be used to describe disagreement with, or alternatives to the reporter's assessment.

Enter the reporter's comments on the causality assessment, diagnosis, or other relevant topics.

Select the Study associated with the report. Once a Study is selected, the study name fields are hidden and the available field values and Registrations from the Study are automatically added to the Case upon saving. Otherwise, you can enter the study information manually.

For more information, see Manage Studies.

Vault populates this field according to the Blinded setting on the selected Study. This field is read-only.

The type of study for which the product was administered. Depending on your Vault's configuration, this field may only appear when the Report Type is Study.

If this field is preconfigured in the associated Study, Vault automatically populates this field. Otherwise, you can manually select the value.

The following options are available by default:

• Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
• Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
• Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.

Enter the study number for the Study that the Case is associated with.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

If entering the study information manually, enter the name of the study.

If entering the study information manually and the study name exceeds the character limit in the Study Name field, you can enter additional characters in this field.

If entering the study information manually and the study name is masked or unavailable, select the reason why the study name is unavailable.

This field appears once the Case is unblinded.

Select the option that best describes who unblinded the Case. By default you can either select Sponsor or Investigator.

This field appears once the Case is unblinded.

Enter the reason the Case was unblinded.

This field appears once the Case is unblinded.

Enter the date when the Case was unblinded.

Reference link to the Case.

Vault automatically populates this field.

Manually enter the study registration number as assigned by the reporting country or region. For trials registered in the EU, use this field to enter the EudraCT number.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The country where the study is registered.

Select the country from the list or start typing for instant search.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Reference link to the Case.

Vault automatically populates this field.

Select the related Case.

Enter the identification number for the report which is linked to this report.

This field controls whether the linked report is included in outbound E2B transmissions for this Case.

To populate the related Case UID in E2B transmissions, select Yes.

Reference link to the Case.

Vault automatically populates this field.

(Required) If this report was previously exchanged, or is currently being exchanged, using a different identifier, enter the identification number.

For example, you can use this field for the following use cases:

• Capture a case identifier from a legacy system.
• Capture the ID for a report transmitted from another manufacturer who is not the license holder for the suspect product.

Enter the name of the organization that associates the report with this identifier.

Select one of the following options:

For example, you can use this field for the following use cases:

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

Your Admin can configure additional Case Identifier Types.

When you save the document, Vault generates a document name using Vault Safety's naming conventions for the associated document type.

(Optional) Enter a descriptive name for the document.

The document type selected during upload, which should be Case.

The document subtype selected during upload, which should be Source.

The classification selected during upload, which should be Attachment or Literature.

The document version number.

Vault populates this field.

(Required) Select the Organization associated with the Case.

A value that uniquely identifies the source of this document's content, such as a Vault document's Global ID.

Optionally, enter an identifier.

A value that uniquely identifies the source of this document version's content, such as a Vault document's Global ID.

Optionally, enter an identifier.

The Lifecycle Stage the document is in.

Vault populates this field.

The Lifecycle State Stage ID the document is in.

Vault populates this field.

The Case Access Group inherited from the associated Case. Vault populates this field.

This field does not appear on layouts by default. Depending on your organization's security configuration, it may be added by your Admin.

Vault populates this field with any applicable document tags.

Reference link to the Case.

Vault populates this field when you add the document to a Case.

Reference link to the source Inbox Item.

Vault populates this field when you create an Inbox Item from a document.

Reference link to an Inbound Transmission.

Vault populates this field if this document was received from an Inbound Transmission.

To include the document in E2B transmissions, select Yes.

For EMA E2B submissions, attachment file size cannot exceed 15 MB. All Vault Safety E2B Transmissions have a maximum total size limit of 100 MB.

For more information, see E2B Document Attachments and Literature References.

For attachments, enter a description of the document. The character limit for this field is 1,500, including spaces.

For attachments, if the description exceeded the character limit in the Description field, continue the description.

For literature, select the classification. By default, the following options are available:

• Clinical trial/research
• Non-clinical trial/research

For literature, select the country in which the literature was published.

For literature, enter the citation for the literature reference.

For literature, if the citation is unavailable, select the reason why this information is omitted.

Indicates whether blind protection is enabled for the document.

If the document contains sensitive unblinded data, select On to enable blind protection on the document.

If you enable this option, only authorized users can view the document. By default, only users assigned the Head of Safety or Medical Reviewer user role will be able to view documents with blind protection enabled.

Admins can edit Dynamic Access Control (DAC) sharing rules on the document lifecycle to change which user groups have access to blind-protected documents. See About Dynamic Access Control for Documents for more information on modifying DAC.

To link this document to a Product, select the associated Product record. The options are filtered by the Organization on the document.

To link this document to a Product, select the associated Study record. The options are filtered by the Organization on the document.

For attachments, identifies if the document is an over-the-counter (OTC) carton image.

When sending FDA E2B(R2) or FDA E2B(R3) Transmissions for a Case with OTC Drugs through an AS2 Connection, select FDA Carton Attachment.