Case Field Reference

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 used for the UID changes, Vault updates the UID to match the new country code. This behavior applies only 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: The Vault-generated value in the Case Number field.

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

Hover over the Case Number to display the worldwide unique case identification (WWUID). The WWUID identifies an external safety case, for example, a previously submitted case received from an MAH or partner.

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

Enter 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 change this date, any previously recorded New Info Dates will appear in the audit trail.

Vault populates the Study Type on the Study. If blank, you can select one of the following:

• 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.

Depending on your Admin's configuration, this field may display only when the Report Type is Study.

1. A Case Adverse Event matches an expedited watchlist.
2. The Case meets seriousness criteria and contains an unexpected serious adverse event.
3. A Case Adverse Event matches an expedited watchlist, and the Case includes an unexpected serious adverse event.

Select the checkbox to prevent Vault from generating Submissions or including this case in aggregate reporting. You can use this field to track and monitor non-submittable cases (for example, pregnancy, invalid, or nullified cases).

Vault populates a value based on the most critical Seriousness across all Case Adverse Events, regardless of Rank. When Case Adverse Events are added or deleted, or the Seriousness changes, Vault updates this field.

When the Rank field on all Case Adverse Events includes a Vault-populated value based on Case Adverse Event auto-ranking, Vault populates Auto Calculated in this field.

When you edit any field considered for auto-ranking, Vault updates this field to Overridden. If you re-run auto-ranking, Vault updates this field to Auto Calculated.

• The Seriousness is blank
• The Device Report Type contains Malfunction
• The MedDRA term for the Case Adverse Event is either 10067482 (PT) or 10077536 (SOC)

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

If Vault populates the Device Report Type based on the Malfunction field of Device-type Case Products, Vault populates Auto-Calculated in this field. If you edit the Device Report Type, Vault updates this value to Overridden.

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

If remedial action was taken, select the option that best describes the action or select Other to enter a text description in the Remedial Action-Other field.

When the Remedial Action is Other, describe the remedial action that was taken.

Select whether the Transmission is an Amendment or Nullification. Upon first generation, Vault copies this value to the Reason field of the Transmission.

Enter a reason for the amendment or nullification. Upon first generation, Vault copies this value to the Reason Text field of the Transmission.

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

Your Admin can configure additional types.

Vault populates Yes or No to indicate whether the Case is blinded. During unblinding, Vault populates No when at least one study Case Product is Unblinded and there are no study Case Products set to Blinded.

Vault populates the Study Type on the Study. If blank, you can select one of the following options:

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

Depending on your Admin's configuration, this field may display only when the Report Type is Study.

• 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.

Vault calculates the normalized age at onset in years. Vault uses this value to populate the Age at Onset, if blank.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit the patient Date of Birth or the adverse event Onset date, Vault recalculates and overwrites the manually entered value.

Enter the patient's age at the time the primary vaccine-type product was administered. Vault maps this value to FDA VAERS(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

When the primary Case Product is a Vaccine-type Product, Vault calculates this value upon Case promotion or update. Vault calculates the age at vaccination using the time interval between the following dates when both dates are precise to, at minimum, the day:

• The patient's Date of Birth
• The First Admin Date on the primary Vaccine-type Case Product Dosage. If multiple dosages exist, Vault uses the earliest date.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a value used for auto-calculation, Vault recalculates and overwrites the manually entered value.

• 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, select a Reason Omitted to describe why the information is unavailable.

• 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, select a Reason Omitted to describe why the information is unavailable.

• 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, select a Reason Omitted to describe why the information is unavailable.

• The study subject ID
• The investigation number

You can enter multiple sets of record numbers in this field. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

Enter any patient medical history and concurrent conditions that could not be coded as Medical History records. If there is no medical history, you can enter None.

Enter the state or province where the contact resides. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

If the state or province is mapped to a domestic state code on a Country State/Province record, a corresponding Country picklist appears. 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.

Select the characterization of the drug role in the adverse event as provided by the primary reporter or sender. A valid 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 export to FDA MedWatch 3500A forms, the Drug Role must be Suspect, Interacting, or Drug Not Administered.

Enter the name of the product, as reported by the source. Then, you can code the reported product to a company product.

When adding unblinded or open label Study Products to a Case, if there is no reported product, 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 overwrite the field if it is populated.

Vault populates a link to the Product. You can select the Product from the drop-down, which includes only Products related to the Case Organization.

For deprecated Products and Product Registrations, a DEPRECATED tag displays.

• The Destination is FDA
• The document type is FDA eMDR or FDA 3500A
• The Transmission specifies the Case Product

Vault populates the first available Site Report Number based on the Manufacturer Site on the Organization. This is either the earliest Site Report Number with a Site Report Number Status of Not Submitted or the next Site Report Number in the sequence.

If an initial Transmission linked to a populated Site Report Number becomes Inactive or Withdrawn or the Site Report Number Status becomes Not Submitted, Vault clears this field.

Select the appropriate radio button and specify how often the dose was administered:

• Every: Enter a numeric value and then select the applicable interval from the drop-down.
• times per: Enter a numeric value and then select the applicable interval from the drop-down.
• Other: Select the applicable value from the drop-down to indicate the dosage regimen is not specific to a time interval, the exact frequency is unknown, or if only total product dosage is known. For example, if a patient took 100mg of a drug in total, enter 100mg in the Dose field and select Total from this drop-down.

After saving the Case, Vault displays an E2B-compliant description of the values. For example, "4 times per day (.25 days)".

Vault calculates the overall duration of time that the product was administered to the patient based on the First Admin Date and Last Admin Date. If either date changes, Vault recalculates the duration.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a field used in the calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

Vault populates this field when the source Inbox Item includes a Combination Product. This indicates the combination product for which this Case Product is a constituent.

When adding or editing a Case Product to include a Combination Product, Vault automatically downloads related constituent Products and adds them as separate Case Products.

When you add or update information about the product dosage or onset of the earliest adverse event, Vault calculates the total cumulative dose administered until the first sign of an adverse event.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a field used in the calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

After populating the Device Code Type, search for and select the device code. The available options depend on the Device Code Type and the active IMDRF dictionary version.

After saving the Case, the Device Code field includes a link to the associated Device Code record. This displays the following details from the IMDRF Dictionary:

• Device Code Type
• IMDRF Dictionary Version
• Level 1 Code, Definition, Term
• Level 2 Code, Definition, Term
• Level 3 Code, Definition, Term

1. The earliest Onset Date across any serious Case Adverse Events
2. The earliest Onset Date across any non-serious Case Adverse Events
3. If no Case Adverse Events include an Onset Date, Vault populates January 1 and the current year

• Study Product: For Study Products associated with a Study
• Company Product: For any Product that does not have the Non-Company Product setting and is not a Study Product or an External Product
• External Product: For an External Product or any Product with the Non-Company Product setting

Vault selects Yes or No to indicate whether the associated Case Adverse Event matches an Expected term on Datasheets associated with the suspect Case Product or associated Study or Study Products. Vault consideres any MedDRA Lower Level Term 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 overwrite the Vault-calculated value or to enter a value manually.

Vault maps the value in this field on the primary Case Assessment to the Case Expectedness field.

Vault populates Listed or Unlisted to indicate whether the associated Case Adverse Event matches a term on the Datasheet for the Study or Product. Vault considers any MedDRA Lower Level Term (LLT) a match if it is listed on or falls under the hierarchy of the term on the product 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 overwrite the Vault-calculated value or to enter a value manually.

Vault maps the value in this field on the primary Case Assessment to the Case-level Listedness (Core) field.

Vault populates Auto Calculated or Overridden to indicate whether the Listedness (Core) value was Vault-calculated or manually overwritten. Unless configured by your Admin, users in the Intake and Data Entry roles cannot edit this field.

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

Enter the time interval between the first administered dose of the product and when the adverse event started. In the first field, enter a number. In the second field, select the unit of measurement. If set to auto-calculate, Vault calculates the first dose latency. If a value used in the calculation changes, Vault recalculates the latency.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a field used in the calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

Enter the time interval between the last administered dose of the product and when the adverse event started. In the first field, enter a number. In the second field, select the unit of measurement. If set to auto-calculate, Vault calculates the last dose latency. If a value used in the calculation changes, Vault recalculates the latency.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a field used in the calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

To overwrite a Vault-generated Dechallenge value, select an option. Upon report generation, Vault exports a code based on this value instead of the Dechallenge value.

Depending on your Admin's configuration, following Dechallenge recalculation, Vault may clear this field.

Vault populates Yes or No to indicate whether adverse event causality has been established with respect to the suspect product. Vault populates a Causality Established value based on the Case Assessment Result controlled vocabulary corresponding to the Assessment Result on the Case Assessment Result.

Vault considers Causality Established values from primary Case Assessment Results to calculate Relatedness at the Case level.

If configured by your Admin, you can select an assessment result. When populated, Vault uses the Assessment Result (Override) 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.

The following limitations apply to specifying an Assessment Result (Override) value:

• Vault always generates the masked version of aggregate reports.
• When Vault attempts to map the record Name of the Assessment Result controlled vocabulary, it always finds the English record Name instead of the localized record Name. For example, when Vault maps to Result of Assessment for PMDA E2B(R3).

These limitations will be addressed in a future release.

When Vault evaluates the Expected value for a Case 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.

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 adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

For China registrations, a value is required if the NMPA Report Classification is Domestic Reporting Post Marketing or Overseas Reporting Post Marketing. Vault maps this value to the G.k.CN.4 data element of NMPA E2B(R3) reports.

To order the list of adverse events by rank, enter the rank number. Ranked records display in ascending order on the Case and in generated ICSRs. Case Adverse Events ranked as 1 correspond to the primary adverse event. If you change an adverse event to rank 1, Vault updates the rank of the previous primary adverse event to 2.

If Vault populates a value based on auto-ranking, you can overwrite the rank.

Vault calculates the overall duration of time that the patient experienced the adverse event based on the Onset and Cessation dates on the Case Adverse Event. If either date changes, Vault recalculates the duration.

If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a field used in the calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

Upon Case promotion or after performing Inbox Item to Case Compare, if the adverse event Type is Product Quality Complaint, Vault populates this field with the Product on the Inbox Item. If the Product is a combination product, Vault populates the constituent Case Product. When multiple Case Products relate to the same Product, Vault populates the earliest created Case Product.

If you update the adverse event Type so that it is no longer Product Quality Complaint, Vault clears this field and regenerates assessments.

For a parent-child case, use this field to capture E2B-compliant parent information. The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.

Create or select a Parent Information record to link to the current Case. You must select a Case with the Parent Information (parental_case__v) object type.

Enter the patient's age at the time of vaccination. Vault maps this value to FDA VAERS(R3) files.

For Vaccine-type Case Products, Vault calculates the age at vaccination using the time interval between the following dates when both dates are precise to, at minimum, the day:

• The patient's Date of Birth
• The Start Date on the Case Drug History for Case Products with a Product Type of Vaccine.

If either date changes, Vault recalculates the age. If you enter a value after auto-calculation, Vault retains the manually entered value. If you enter a value in this field and then edit a value used for auto-calculation, Vault recalculates and overwrites the manually entered value. Optionally, you can turn off auto-calculation at the field level.

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, Vault prepends this field with [Blind Protection].

Enter the identification number for the report that is linked to this report. For Cases imported from an E2B(R3) or E2B(R2) file, Vault populates the value from the source file.

Based on your Admin's configuration, Vault may populate this field with the UID or Worldwide UID of the related Case:

• Upon Case Relationship record creation.
• Following edits to the Related Case.

Vault does not overwrite manually entered Related Case Identifiers. However, if you edit the Related Case and manually enter a value in the same session before saving, Vault populates this field with the UID or Worldwide UID of the Related Case instead of the manually entered value. To apply the manually entered value, after saving the updated Related Case, enter the Related Case Identifier value and select Save.

Vault populates the assigned access group.

• Pass: No validation rule failures were found.
• Warning: At least one validation rule failed to pass and was given the Warning status.
• Fail: At least one validation rule failed to pass and was given the Fail status.
• Hard Fail: At least one validation rule failed to pass and was given the Hard Fail status.

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

Reportability outcomes include:

• 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 reportable to neither a health authority nor a business partner.