# Case Field Reference Vault _Case_ sections and fields support data entry and validation. For general information on case processing sections, see Case Data Entry Overview. For information on _Case_ fields that are specific to Japan, see PMDA Case Field Reference. ## General Page {#general-page} Use the _General_ page to review and add general information about the _Case_. ### Marked as Follow-up Section {#mark-as-fu} This section identifies _Inbox Items_ that are follow-ups for the _Case_. The following fields may be available:

Field	Description
Name	Vault populates a link to Inbox Items marked as follow-ups to the Case.
Priority	Vault populates the priority level of the Inbox Item.
Significance	Vault populates the Significance on the Inbox Item.
New Info Date	Vault populates the New Info Date on the Inbox Item.
Source Document	Vault populates the Source Document on the Inbox Item.
Special Situation	Vault populates the Special Situation on the Inbox Item.

### Awareness Details Section {#awareness-details} This section identifies high-level details about the _Case_, such as tags, dates, and report type. The following fields may be available:

Field	Description
Case Number	When you create a Case, Vault generates a case number. You cannot edit this field. Outside of Edit mode, hovering over the Case Number displays the UID and Worldwide UID.
UID	Hover over the Case Number to display the UID. The UID is a Vault-generated E2B-compliant unique identifier that is composed in the `{Country}-{Organization UID Code}-{Case Number}` format: 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. Organization UID Code: The value in the Organization UID Code field for the Organization associated with the Case, if available. Case Number: The Vault-generated value in the Case Number field. For initial Cases, Vault reevaluates the UID when the following values change: Country on the primary Reporter-type Case Contact Event Country on the primary Case Adverse Event Note: Vault does not update the UID for imported or follow-up Cases.
Worldwide UID	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. Note: Vault never updates the WWUID, even if the UID changes.
Version	Vault populates the version number of the Case.
Due Date	When you promote an Inbox Item to a Case or run the Recalculate Due Date action on a Case, Vault calculates the earliest reportable due date to an agency (Submission) or partner (Distribution), based on the current Case data. If Vault determines that a Case is not currently reportable to an agency or partner, Vault sets the Due Date to 30 days for non-serious Cases and 15 days for serious Cases.
Due Date Rule	Vault populates the rule or scenario used to determine the Due Date of the Case.
Approval Due Date	Vault populates the date by which a Case must be medically approved. Vault calculates this based on a hierarchical set of rules that prioritize specific rule parameters, One Last Time (OLT) status, and global defaults.
Approval Due Date Rule	Vault populates the rule or scenario used to determine the Approval Due Date of the Case.
New Info Date	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.
Initial Receipt Date	For follow-up Cases, Vault populates the Receipt Date on the Inbox Item. 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.
Receipt Date	Enter the date the event was first reported. 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. This date starts the regulatory clock in calculating expedited reporting (for example, 7-day or 15-day reports).
Study Type	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.
Study	Select the Study. Vault maps information from the Study to populate details such as the Study Registration, Products, Dosage, and Indication.
Case Tags	Based on Case tagging criteria, Vault populates SUSAR, SAE, or leaves this field blank.
Watchlist Tags	Vault populates this field when any Case Adverse Event matches a watchlist for the Case Product or Study.
EDC AESI	Vault populates this field based on data received from the Safety-EDC Connection. This field is for reference so you can review the EDC user's opinion and does not affect Watchlist Tags on the Case.
DME	Vault populates Yes or No to indicate whether the adverse event MedDRA PT matches a Designated Medical Event (DME). For the adverse event to qualify as a DME, the suspect Case Product must be registered in the European Union.
Manufacturer Reportable Awareness Date	Enter the date when the manufacturer became aware of the report. Use the calendar to select the date or enter the date manually. During report generation, Vault maps this value to EU MIR form field 1.2d.
Primary Event (PT)	When you code the MedDRA Preferred Term (PT) on the primary Case Adverse Event, Vault populates the PT in this field. If the PT on the primary Case Adverse Event changes, Vault updates this field.
Primary Event Seriousness	Vault populates the Seriousness values on the primary Case Adverse Event.
Relatedness	Vault calculates the relatedness based on the primary Case Assessment and the associated Case Assessment Results.
Expedited	Vault populates Yes or No to indicate whether the case requires expedited reporting. Cases are expedited when any of the following conditions exist: A Case Adverse Event matches an expedited watchlist. The Case meets seriousness criteria and contains an unexpected serious adverse event. A Case Adverse Event matches an expedited watchlist, and the Case includes an unexpected serious adverse event.
CIOMS Remarks	Enter any comments or additional information that should export to the field 26 on CIOMS I forms.
Suppress Submission	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). Note: Selecting this checkbox does not prevent Vault from generating Distributions to partners.
Source Document	Select a source document. For Cases generated from source documents, Vault populates a link to the document.
Source Literature Review	Select a Literature Review. For Cases generated from Literature Articles, Vault populates a link to the Literature Review in SafetyDocs that includes the source Literature Article for the report.
Source Literature Article	Select a Literature Article. For Cases generated from Literature Articles, Vault populates a link to the Literature Article in SafetyDocs.
Version	When you attach or create a Case from a source file, Vault populates the version number of the source document. Use the link to navigate to the document.
Reason Received Late	Enter the reason the case was received late.
External System UID	Enter the unique identifier for an external system. If available, Vault maps the External System UID on the related Inbox Item.
FDA Summary Type	Select whether the summary type is Aggregate or Summary. Vault considers this value when populating the FDA.D.11.r.1 and FDA.D.12 data elements on FDA FAERS E2B(R3) reports.
Number of Cases	Vault populates the number of Case copies created from the open Case. When you copy a Case, if this field contains a value Vault populates the number in the Copy Case dialog.
Market Segment	Vault populates the market segment associated with the study for study Cases or the primary Product for postmarket Cases.
Potential PQC	Vault populates Yes if any Case Assessments have a Potential PQC value of Yes, which you can send to a Quality Vault using the Quality-Safety Connection.
Routing Tags	Select Routing Tags for the Case. Vault populates a Routing Tag for each Case Assessment that meets an Individual Case Routing Criteria configured by your Admin.
Overall Case Seriousness	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. Note: Overall Case Seriousness does not roll up the device-specific seriousness value Required Intervention to Prevent Permanent Impairment/Damage (Devices).
Event Rank (Status)	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.
System Alerts	When a Case encounters a failure while attempting to change lifecycle state, Vault populates this field with State Change Failure and logs an audit trail record with information on the failure. When the Case moves out of the stuck state, Vault clears this field.

### Report Details Section {#report-details} This section displays information about the safety report. Some fields appear only for certain product types. The following fields may be available:

Field	Description
Localization	Vault populates the Localization on a domestic Case after you promote an Inbox Item with a non-English Localization.
Intake Method	Vault populates the method of intake for the Inbox Item, such as Email.
Intake Format	Vault populates the format the Inbox Item was created from, such as an E2B file.
Special Situation	Select the special situation for which the Case may require additional consideration.
Invalid Reason	Select the reason the Case is invalid.
Special Report Classification	For reporting to the PMDA, select whether the Case is a Safety Measure Report or a Research Report.
Malfunction Only	Vault populates Yes when all of the following conditions on the Case are met: 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.
Device Follow-Up Type	Select reasons for the follow-up. This field does not appear for initial Cases.
Device Report Type	Select one or more device report types. If the Malfunction value is Yes on any combination product device constituent or any company Product with a Transmission Product Type of Device, Vault populates Malfunction.
Device Report Type (Status)	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.
Remedial Action	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. Note: This is a Case-level remedial action. You can add Case Product-level remedial actions in the Remedial Action field of Case Product Device records. When generating ICSRs, Vault exports remedial actions from the Case Product Device level, if they exist. If there are none, Vault exports the Case-level remedial action.
Remedial Action-Other	When the Remedial Action is Other, describe the remedial action that was taken. Note: This is a Case-level remedial action. You can add Case Product-level remedial actions in the Remedial Action Other field of Case Product Device records. When generating ICSRs, Vault exports remedial actions from the Case Product Device level, if they exist. If there are none, Vault exports the Case-level remedial action.
Transmission Reason	Select whether the Transmission is an Amendment or Nullification. Upon first generation, Vault copies this value to the Reason field of the Transmission. Note: During manual Transmission creation, entering a value in the Transmission Reason field of the Transmission overwrites the Case-level value.
Transmission Reason Text	Enter a reason for the amendment or nullification. Upon first generation, Vault copies this value to the Reason Text field of the Transmission. Note: During manual Transmission creation, entering a value in the Reason Text field of the Transmission overwrites the Case-level value.

### Local Details Section {#local-details} This section may appear on domestic Cases. ### Case Identifiers Section {#case-ids} This section displays identifiers for the _Case_. The following fields may be available:

Field	Description
Case Identifier	If this report used a different identifier when previously exchanged or during a current exchange, enter the identification number. This may be useful to capture a case identifier from a legacy system or to capture the ID for a report transmitted from another manufacturer who is not the license holder for the suspect product.
Source	Enter the name of the organization that associates the report with this identifier.
Type	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.

Field

Description

Case Identifier

If this report used a different identifier when previously exchanged or during a current exchange, enter the identification number. This may be useful to capture a case identifier from a legacy system or to capture the ID for a report transmitted from another manufacturer who is not the license holder for the suspect product.

Source

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

Type

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.

## Study Page {#study-page} Use the _Study_ page to specify information about the relevant study and study registrations. ### Study Section Fields {#study-section} The following _Study_ section fields may be available:

Field	Description
Study	Select the Study associated with the report. Once you select a Study, Vault hides the study name fields and, upon saving the Case, adds the available field values and registrations from the Study. Otherwise, you can enter the study information manually.
Study Blinded	Vault populates Yes or No based on the Blinded value on the selected Study.
Case Blinded	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.
Blind Protection	Vault populates a value to indicate whether Blind Protection is active for the Study Product. This field is blank on blinded Cases. Blind protection becomes active after unblinding the Case.
Masking	Vault populates a value to indicate whether the Study Product is currently blinded, unblinded, or open label. Depending on your Admin's configuration, this field's label may display as Blinded.
Unblinded Date	Enter the date when the Case was unblinded. Vault displays this field only after Case unblinding.
Unblinded By	Select the option that best describes who unblinded the Case. Vault displays this field only after Case unblinding.
Unblinded Reason	Enter the reason the Case was unblinded. Vault displays this field only after Case unblinding.
Study Type	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.
Study Number	Vault populates the Study Number on the Study. If entering study information manually, enter the number of the study. If the study number is masked or unavailable, select a Reason Omitted to describe why the information is unavailable.
Study Number (Reported)	For Cases that are not in a terminal state, users with Vault Owner permissions can edit this field.
Study Name	If entering the study information manually, enter the name of the study.
Study Name (Continued)	If you manually entered a Study Name and the value exceeds the character limit of the field, enter additional text in this field.
Study Name (reason omitted)	If entering the study information manually and the study name is masked or unavailable, select a Reason Omitted to describe why the information is unavailable.

### Study Registrations Section Fields {#study-registration-section} The following _Study Registrations_ section fields may be available:

Field	Description
Registration Number	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, select a Reason Omitted to describe why the information is unavailable.
Registration Country	Select the country where the study is registered. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

## Case Page {#case-page} Use the _Case_ page to specify information about the relevant patient, contacts, products, and adverse events. ### Patient Section {#patient-section} Use the _Patient_ section to enter patient information, including a name or identifier, age, sex, height, weight, and medical record numbers (MRNs). Vault automatically calculates certain patient age fields. Optionally, you can turn off auto-calculation at the field level. For _Cases_ with SAEs transferred from the Safety-EDC Connection, you can run the _Add Relevant Subject Information_ action to add the applicable subject information to the _Case_. The following fields may be available:

Field	Description
Patient Initials / ID	Enter the patient's initials. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Patient Known to Exist	Select the checkbox when there is a known patient involved in the case. This information is required for reporting obligations in certain jurisdictions. A known patient exists, for example, if any of the following conditions 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.
Patient Name Prefix	Enter the patient's name prefix or title. 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.
Patient First Name	Enter the patient's first name. 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.
Patient Middle Name	Enter the patient's middle name. 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.
Patient Last Name	Enter the patient's last name. 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.
Sex	Select the patient's sex. Depending on your Admin's configuration, this field may display as Gender. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Gender	Select the patient's gender identity or enter a custom value.
Date of Birth	Enter the patient's birth date. Use the calendar to select the date or enter the date manually. Export to E2B transmissions requires the full date with year, month, and day. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Age (normalized)	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.
Age at Onset	Based on the Vault-calculated Age (normalized) value, upon Case promotion or update, Vault populates the patient's age at the onset of the adverse event.
Age Group	Based on the Age at Onset, Vault populates the patient's age group at the onset of the adverse event.
Age at Vaccination	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.
Date of Death	Enter the date when the patient was reported as deceased. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Height	Enter the patient's height. In the first field, enter a number. In the second field, select the unit of measurement.
Weight	Enter the patient's weight. In the first field, enter a number. In the second field, select the unit of measurement.
Race	Select the patient's race. Vault maps this value to all FDA report formats, except FDA E2B(R2) files.
Ethnicity	Select the patient's ethnicity. Vault maps this value to FDA VAERS(R3) files.
Concomitant Therapies	Select whether the patient was being treated with concomitant therapies, such as radiotherapy, drug class, or dietary supplements, at the onset of the adverse event.
GP MRN	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, select a Reason Omitted to describe why the information is unavailable.
Specialist MRN	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, select a Reason Omitted to describe why the information is unavailable.
Hospital MRN	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, select a Reason Omitted to describe why the information is unavailable.
Investigation MRN	If a clinical trial investigated the adverse event, enter the following information: 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.
EDC Subject Information	Vault populates this field based on data received from the Safety-EDC Connection.
Randomization Number	Enter the patient's randomization number from the clinical trial randomization system. Vault can populate this field during a bulk unblind operation using the study participants CSV file.
Military Status	Select the patient's military status type. Vault maps this value to FDA VAERS(R3) files.
Last Menstrual Period	Enter the date when the patient last experienced a menstrual period. This field displays only if the Sex is Female. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Pregnancy	Select the checkbox to identify a case as a pregnancy case for tracking and capturing pregnancy information. This field displays only if the Sex is Female.
Pregnant at Exposure	Select whether the patient was pregnant at the time of exposure. 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. This field displays only if the Sex is Female.
Medical History Text	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`. Note: Depending on your Admin’s configuration, the Medical History Text field includes only Reasons Omitted that are valid for E2B submissions.
Medical History Text (reason omitted)	If the source report omits medical history and concurrent conditions information, select a Reason Omitted to describe why the information is unavailable.
Autopsy	Select whether an autopsy was performed. This field displays if a Date of Death exists. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

### Contacts Section {#contacts-section} The _Case Contact_ type determines which fields and _Reason Omitted_ options are available. The following fields may be available:

Field	Description
Type	On the Create Case Contact dialog, select the type of contact.
Qualification	Select the contact's qualification.
Primary Source	Select whether the reporter is the primary source.
Title	Enter the contact's title. If the contact type is Reporter or Patient and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
First Name	Enter the contact's first name. If the contact type is Reporter or Patient and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Middle Name	Enter the contact's middle name. If the contact type is Reporter or Patient and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Last Name	Enter the contact's last name. If the contact type is Reporter or Patient and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Facility Name	Enter the name of the facility. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Facility Type	Select the type of facility. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Organization	Enter the name of the contact's organization. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Department	Enter the name of the contact's department in their organization. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Telephone	Enter the contact's telephone number. If the contact type is Reporter, Patient, or Facility and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Email	Enter the reporter's email address. To send automatic questionnaire emails for follow-up information, you must populate both Email and Email Consent Provided. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Email Consent Provided	Select the checkbox if the contact has consented to receiving email notifications or requests for follow-up information.
Fax	Enter the contact's fax number. If the contact type is Facility and the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Best Doctor?	Select the checkbox to indicate the contact is the best physician or health care professional to contact about the case.
Sent to FDA?	Select whether the case has already been reported to the FDA.
Other Source Text	Enter any additional relevant information about the reporter.
FDA 3500A Report Source	Select the source of the FDA MedWatch 3500A report.
Additional Information	If the contact type is Health Care Professional, enter any additional information that cannot be captured in the other contact fields.
Facility Military Flag	Select whether the facility has a military designation.
Rank	To order the list of reporters by rank, enter the rank number. Ranked records display in ascending order on the Case and in generated ICSRs. 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.

#### Case Contact Address Subsection Fields Use the _Address_ section on _Case Contacts_ to add address information about a reporter, patient, or facility. Vault does not display this section for the _Health Care Professional_ type of _Case Contact_. The following fields may be available:

Field	Description
Street	Enter the contact's street address. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Street Line 2	Enter the second line of the street address. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
PO Box	Enter the contact's PO box.
City	Enter the name of the city where the contact resides. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
County	Enter the county where the contact resides. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
State / Province	Enter the state or province where the contact resides. If the source report omits this information, 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.
Country	Select the country where the contact resides. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Postal Code	Enter the contact's zip or postal code. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

### Products Section {#products-section} Use the _Products_ section on the _Case_ to enter information about suspect and concomitant medications, including products suspected to have had an interaction. Depending on the type of product, the following subsections may be available: * [_Product_][1] * [_Indications_][2] * [_Dosages_][3] * [_Combination Products_][4] * [_Substance_][5] * [_Substances_][6] * [_Device_][7] * [_Device Code_][8] * [_Device Incident Report_][9] * [_Device Manufacturer Analysis_][10] * [_Case Product Similar Incident_][18] * [_Device Problem and Evaluation Codes_][17] * [_Assessment_][11] * [_Registration_][12] * [_Name Parts_][13] * [_Regional_][14] #### Product Subsection Fields {#product-fields} The following _Product_ subsection fields may be available:

Field	Description
Study	For Study Products, Vault populates the associated Study.
Primary	Select whether the product is the key suspect product of interest. You cannot designate External Products as primary.
Rank	To order the list of Case Products by rank, enter the rank number. Ranked records display in ascending order on the Case and in generated ICSRs. 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.
Drug Role	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. Note: For Combination Products, if the Drug Role is changed on a constituent Product, Vault applies the change to all constituents.
Country Obtained	Select the country where the product was obtained.
Product (Reported)	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.
Product	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.
Product Code	For devices only, enter the product code classification.
Manufacturer Site	For devices only, select the site where the Case Product was manufactured. Vault uses this field when generating reports to the FDA. If there is one Manufacturer Site associated with the Product Registration, Vault populates this value.
FDA Reason for Device Non-Evaluation	For devices only, select the reason the device was not evaluated. Vault uses this field when generating reports to the FDA.
FDA Manufacturer Report Number	For devices only, when this field is blank, Vault populates a value following Transmission generation that meets all of the following criteria: 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. Note: If this field is populated and then the Case Product changes on a Transmission for a follow-up Case, Vault does not clear this field.
WHODrug	Vault displays the product code from the WHODrug dictionary. This field displays for External Products only. Vault populates this field when the External Product is selected through the WHODrug Search browser. Depending on your Admin's configuration, Vault may populate this field by cross-referencing it to the code you enter in the JDrug or Korea Drug fields, or when the External Product is selected through the WHODrug Chinese Search browser.
WHODrug Chinese	Vault displays the product code from the WHODrug Global Chinese. This field displays for External Products only. Vault populates this field only when the External Product is selected through the WHODrug Chinese Search or WHODrug Search browser.
JDrug	Vault displays the product code from the Japan Drug Dictionary (JDD). This field displays for External Products on domestic Cases for Japan only. Depending on your Admin's configuration, Vault may populate this field by cross-referencing it to the code you enter in the WHODrug field.
Korea Drug	Vault displays the product code from the Korea Drug Dictionary. This field displays for External Products on domestic Cases for Korea only. Depending on your Admin's configuration, Vault may populate this field by cross-referencing it to the code you enter in the WHODrug field.
MPID	Vault displays the UMC Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code and is populated based on the selection from the WHODrug dictionary.
IDMP MPID	Vault displays the IDMP Medicinal Product Identifier (MPID) value for the product. This field appears after coding the WHODrug product code and is populated based on the selection from the WHODrug dictionary.
Version	Vault displays the WHODrug version for the MPID. This field appears after coding the WHODrug product code and is populated based on the selection from the WHODrug dictionary.
Globally Registered As	Vault populates the Transmission Product Type in the Registered As field on the Product Registration.
External Product Type	For External Products, select the product type to display specific product fields. For example, certain fields appear only when you select Vaccine as the External Product Type.
Action Taken	Select the action taken with the product as a result of the adverse event. When you add or edit an Action Taken, Vault recalculates Dechallenge values on Case Assessments.
Additional Information	If there is additional information relevant to the product and its usage, select an option. If you cannot describe the additional information with any of these options, type the text in the Other Additional Information field.
Other Additional Information	If none of the options in the Additional Information picklist apply, use this field to enter any additional product information.
Device Comments	Enter general comments about the device and incident. During report generation, Vault maps this value to Section 5 on the EU MIR form.
Number of Patients Involved	Enter the number of patients involved in the report. During report generation, Vault maps this value to EU MIR form field 3.2b.
Periodic Summary Report (PSR) ID	Enter the Periodic Summary Report (PSR) ID for similar associated incidents. During report generation, Vault maps this value to EU MIR form field 1.3e.
Risk Assessment Results	Enter the results of the risk assessment. During report generation, Vault maps this value to EU MIR form field 4.2d.
Expiration Date	Enter the expiration date of the product. Use the calendar to select the date or enter the date manually. If configured by your Admin, you can enter partial dates with a minimum precision of the year.
Blinded Name	Vault populates the Blinded Name (Study Product Placeholder) in the Inbox Item Study Product field.
Product Registration	Select the Product Registration.
Blinding Type	Identifies whether a clinical trial study Case Product is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Products, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Indications Subsection Fields {#indications-fields} Use the _Indications_ section to specify the reported and MedDRA coded usage for the product in treating a medical condition. The following fields may be available:

Note: When there are no Indication records, the Case Product Indication section appears blank. To access the button to create an Indication, select Edit on the Case Product.

Field	Description
Indication (Reported)	Enter the reported indication for product use to code the MedDRA term.
Reason Omitted	If the source report omits this information, select a Reason Omitted to describe why the information is unavailable. Selecting a nullFlavor automatically codes the MedDRA term "Drug use for unknown indication (10057097)" below the Indication (Reported) field.
Blinding Type	Identifies whether a clinical trial study Case Product Indication is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Product Indications, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Dosages Subsection Fields {#dosages-fields} The following _Dosages_ subsection fields may be available:

Field	Description
Dose	Enter the amount of product administered at one time. In the first field, enter a number. In the second field, select the unit of measurement or create a custom entry.
Frequency	Select the appropriate radio button and specify how often the dose was administered: Every: Enter a numeric value and then select the applicable interval from the drop-down. times per: Enter a numeric value and then select the applicable interval from the drop-down. Other: Select the applicable value from the drop-down to indicate the dosage regimen is not specific to a time interval, the exact frequency is unknown, or if only total product dosage is known. For example, if a patient took 100mg of a drug in total, enter `100mg` in the Dose field and select Total from this drop-down. After saving the Case, Vault displays an E2B-compliant description of the values. For example, "4 times per day (.25 days)".
First Admin Date	Enter the date and time when the product was first administered. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Last Admin Date	Enter the date and time when the product was last administered. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Duration	Vault 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.
Dose Form (Reported)	Select a description of the pharmaceutical dose form or create a custom entry.
Patient RoA	Select the route of administration code for the patient or create a custom entry. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Parent RoA	For the parent for a parent-child or fetus report, select the route of administration code or create a custom entry. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Administration Facility	If the product is a vaccine, select the facility where the vaccine was administered. This field displays only when the Case Product type is Vaccine or Company Product. The options available correspond to the Facility-type Case Contacts added to the Case. Vault maps this value to FDA VAERS(R3) files.
Anatomical Site	If the product is a vaccine, select the anatomical site to which the dosage was administered. This field displays only when the Case Product type is Vaccine or Company Product. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable. Vault maps this value to FDA VAERS(R3) files.
Dose Number in Series	Enter the dose number in the series. This field displays only when the Case Product type is Vaccine or Company Product. Vault maps this value to FDA VAERS(R3) files.
Dosage Text	Enter a description of the dosage when there is information that does not apply to the other Dosage fields.
Batch/Lot Number	Enter the batch or lot number for the medicinal product. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Expiration Date	Enter the product expiry date for the batch/lot number. Use the calendar to select the date or enter the date manually. You can enter a full or partial date. A partial date is one that specifies only the year or both the year and the month.
Blinding Type	Identifies whether a clinical trial study Case Product Dosage is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Product Dosages, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

##### Dose Form (Coded) Subsection Fields The following _Dose Form (Coded)_ subsection fields may be available:

Field	Description
Dose Form TermID	Enter the TermID for the dose form.
Dose Form TermID Version	Enter the version of the TermID for the dose form.

##### Route of Administration (Coded) Subsection Fields The following _Route of Administration (Coded)_ subsection fields may be available:

Field	Description
Patient RoA TermID	Enter the TermID for the patient route of administration.
Patient RoA TermID Version	Enter the version of the TermID for the patient route of administration.
Parent RoA TermID	Enter the TermID for the parent route of administration.
Parent RoA TermID Version	Enter the version of the TermID for the parent route of administration.

#### Combination Details Subsection Fields {#combo-fields} The following _Combination Product_ fields may be available:

Field	Description
Combination Type	If the product is a combination product, select the combination type. This field applies to FDA reporting.
Combination Product	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. Note: If the Combination Product is a Study Product, all constituent products inherit that setting. The Case-level study is applied to each constituent product.
Combination Product Registration	Vault populates a link to the Combination Product Registration, as configured in the Product library. If the product registration details are already configured in the Product library, select the Product Registration.

Field

Description

Combination Type

If the product is a combination product, select the combination type. This field applies to FDA reporting.

Combination Product

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.

Note: If the Combination Product is a Study Product, all constituent products inherit that setting. The Case-level study is applied to each constituent product.

Combination Product Registration

Vault populates a link to the Combination Product Registration, as configured in the Product library. If the product registration details are already configured in the Product library, select the Product Registration.

#### Substance Subsection Fields {#substance-fields} The following _Substance_ section fields may be available:

Field	Description
Compounding Type	Select the type of compounded product.
Cumulative Dose	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.
Vaccine Type	Enter the type of vaccine 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.
Gestation Exposure	Enter the gestational age at the time of the earliest exposure. In the first field, enter a number. In the second field, select the unit of measurement. The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.
FDA Additional Information on Drug	Categorize the Case Product according to FDA-specific additional information. Vault maps this value to the FDA.G.k.10a data element of FDA FAERS E2B(R3) reports.

#### Substances Subsection Fields {#substances-fields} Use this section to enter information about substances related to the case.

Field	Description
Case	Vault populates a link to the grandparent Case.
Case Product	Vault populates a link to the parent Case Product.
Substance Name	Enter the substance name, as reported.
Strength	Enter the substance strength. If the strength is a range, enter the lowest number in the range. In the first field, enter a number. In the second field, select the unit of measurement.
Blinding Type	Identifies whether a clinical trial study Case Product is blinded.
Blinded Reference ID	This field is always blank.

##### Substance Details Subsection Fields Use this section to enter information about the TermID for the substance. For more information on how Vault populates these field values, see Code WHODrug Products.

Field	Description
TermID	Enter the substance TermID. When Vault creates a Case Product Substance for a coded External Product, Vault populates this field with the Chemical Abstract Service (CAS) number of the Substance Name.
TermID Version	Enter the substance TermID Version or Version Date. When Vault creates a Case Product Substance for a coded External Product, Vault populates this field with your Vault's active WHODrug dictionary version.

#### Device Subsection Fields {#device-fields} Use the _Device_ sections to enter details about _Device_ type of _Case Products_. By default, this section appears only for _External Products_ and _Device Products_. When the _Case_ includes a _Company Product_, this section appears if the _Registered As_ field on the _Product Registration_ is _Device_. The following fields may be available:

Field	Description
Model Number	Enter the model number assigned to the medical device by the manufacturer.
Catalog Number	Enter the catalog number assigned to the medical device by the manufacturer.
Lot Number	Enter the lot number assigned to the medical device by the manufacturer.
Serial Number	Enter the serial number assigned to the medical device by the manufacturer.
Software Version	Enter the version of the device software.
Firmware Version	Enter the version of the device firmware.
Unique Identifier	Enter the unique identification code assigned to the medical device by the manufacturer.
Unique Identifier Issuing Entity	Select the entity your organization used to assign UDIs. During report generation, Vault maps this value to EU MIR form field 2.1a.
UDI Production Identifier	Enter the numeric or alphanumeric code that identifies the unit of device production.
Unit of Use UDI-DI	Enter the Unit of Use UDI-DI identifier. During report generation, Vault maps this value to EU MIR form field 2.1d.
Unit of Use UDI-DI Issuing Entity	Select the entity your organization used to assign the Unit of Use UDI-DI. During report generation, Vault maps this value to EU MIR form field 2.1d.
Operator of Device	Select the type of operator using the medical device.
Operator of Device (Other)	If the Operator of Device picklist does not contain a suitable option, select Other for this field to appear. Then, enter a text description of the medical device operator.
Single Use	Select whether the medical device is labeled for single use.
Reprocessed/Reused	Select whether the single-use medical device was reprocessed and used for a subsequent application. Vault populates this value in box 7b. of FDA MedWatch 3500A forms.
Reprocessor	Enter the name and contact information of the contact who reprocessed the medical device. Vault populates this value in box 7b. of FDA MedWatch 3500A forms.
Correction/Removal Reporting Number	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. Vault populates this value in Section H box 9. of FDA MedWatch 3500A forms.
Device Available	Select whether the device is available for further evaluation.
Implant Facility	Enter details about the healthcare facility where the device was implanted.
Date Implanted	Enter the date when the medical device was implanted in the patient. Use the calendar to select the date or enter the date manually. You can enter a full or partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Explant Facility	Enter details about the healthcare facility where the device was explanted.
Date Explanted	Enter the date when the medical device was removed from the patient. Use the calendar to select the date or enter the date manually. You can enter a full or partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Returned Date	Enter the date when the medical device was returned to the manufacturer. Use the calendar to select the date or enter the date manually. You can enter a full or partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Manufacture Date	Enter the date when the device was manufactured. Use the calendar to select the date or enter the date manually.
Device Usage Type	Select the product usage type for the device-type product.
Usage of Device (Other)	Enter details about the usage of the device at the time the incident occurred.
Device Age	Enter the age of the device. In the first field, enter a number. In the second field, select the unit of measurement.
Current Device Location	Select the current location of the device.
Current Device Location (Other)	If the Current Device Location is Other, enter a description of the current location of the device.
Device Nomenclature Code	Enter the nomenclature code for the device.
Relevant Accessories	Enter details about relevant accessories used with the device being reported on.
Relevant Associated Devices	Enter details about relevant associated devices used with the device being reported on.
Additional Device Manufacturer Narrative	Enter any additional information, evaluation, or clarification of information previously entered. Vault populates this value in Section H box 10. of FDA MedWatch 3500A forms.
Device Evaluated	Select Yes, No, or Not Returned to Manufacturer to indicate whether the device has been evaluated by the manufacturer. Vault populates this value in Section H box 3. of FDA MedWatch 3500A forms.
Third-party servicer for device?	Select whether the device was ever serviced by a third-party servicer.
Basic UDI-DI	Enter the Basic UDI-DI key for the Case Product. During report generation, Vault maps this value to EU MIR form field 2.1c.
Basic UDI-DI Issuing Entity	Select the entity your organization used to assign the Basic UDI-DI. During report generation, Vault maps this value to EU MIR form field 2.1c.
EU Market after application date	Select whether the device was continued to be placed on the EU market after the MDR/IVDR date of application. During report generation, Vault maps this value to EU MIR form field 2.4e.
Scientific Opinion Asked	Select whether a scientific opinion has been asked. During report generation, Vault maps this value to EU MIR form field 2.4f.
Competent Authority Consulted	Select whether a competent authority or the European Medicines Agency (EMA) has been consulted. During report generation, Vault maps this value to EU MIR form field 2.4f.
Competent Authority Consulted Name	Enter the name of the competent authority that was consulted. During report generation, Vault maps this value to EU MIR form field 2.4f.
Associated Products	Enter the names of medicinal substances and products, tissues, and cells of human origin or their derivatives that are associated with the device. During report generation, Vault maps this value to EU MIR form field 2.4f.
Initial Product and Incident Assessment	Select whether a relationship between the incident and medicinal substances or product is suspected. During report generation, Vault maps this value to EU MIR form field 4.1b.
Final Product and Incident Assessment	Select whether a relationship between the incident and medicinal substances or product is suspected. During report generation, Vault maps this value to EU MIR form field 4.2b.
Rationale for no review required	Enter the reason the risk assessment was not reviewed. During report generation, Vault maps this value to EU MIR form field 4.2d.
Is reviewed assessment still adequate?	Select whether the reviewed assessment is still adequate. During report generation, Vault maps this value to EU MIR form field 4.2d.

#### Device Codes Subsection Fields {#device-code-fields} The following _Device Codes_ subsection fields may be available:

Field	Description
Device Code Type	Select one of the seven IMDRF annex names for the categories of device codes.
Device Code	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
Rank	To order Case Product Device Codes by rank, enter the rank number. Vault uses the rank to determine the order of IMDRF codes on the EU MIR form.
Blinding Type	Identifies whether a clinical trial study Case Device-type Case Product is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Product Device Code records, for those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Device Incident Report Subsection Fields {#device-incident-report-fields} Use the _Device Incident Report_ section to enter details about Device-type _Case Products_. The fields in this section populate EU MIR and MHRA MIR forms. The following fields may be available:

Field	Description
NCA Reference Number	Enter the reference number assigned by NCA for this incident.
EUDAMED Reference Number	Enter the reference number assigned by EUDAMED for this incident.
Manufacturer Reference Number	Enter the reference number assigned by the manufacturer.
NCA FSCA Reference Number	Enter the NCA's local FSCA reference number. This is the NCA reference number assigned to the FSCA that this incident covers.
EUDAMED FSCA Reference Number	Enter EUDAMED's FSCA reference number. This is the EUDAMED reference number assigned to the FSCA that this incident covers.
Manufacturer FSCA Reference Number	Enter the manufacturer's FSCA reference number. This is the manufacturer reference number assigned to the FSCA that this incident covers.
Submitter of Report	Select who submitted the report. If no options apply, select Other, and populate the Submitter of Report (Other) field.
Submitter of Report (Other)	When the Submitter of Report is Other, enter a description of the report submitter.
Type of Incident Report	Select the type of incident report.
Expected Date of Next Report	Enter the expected date of the next report. Use the calendar to select the date or enter the date manually.
Not Reportable Rationale	Enter details about why the incident was deemed not reportable.
IMDRF Similar Incident Identification	Select an identifier of similar serious incidents using IMDRF Adverse Event Reporting terms and codes.
IMDRF Similar Incident (Other)	When the IMDRF Similar Incident Identification options do not apply, enter the in-house identification codes.
Similar Incident Basis	Select on which basis similar serious incidents regarding the device or device variant were identified.
Similar Incident Basis Details	Enter details about medical device identification most appropriate for categorizing relevant similar serious incidents.
Similar Incident Comments	Enter comments on how similar serious incidents and the associated number of devices on the market were determined.
Devices Marketed Criteria	Select on which criteria the number of devices on the market (also known as denominator data) are based. If no options apply, select Other, and populate the Devices Marketed Criteria (Other) field.
Devices Marketed Criteria (Other)	When the Devices Marketed Criteria is Other, describe on which criteria the number of devices on the market (also known as denominator data) are based.
Medical Device Terminology	Select the medical device nomenclature. If no options apply, select Other, and populate the Medical Device Terminology (Other) field.
Medical Device Terminology (Other)	When the Medical Device Terminology is Other, enter the terminology for the medical device nomenclature.

#### Device Manufacturer Analysis Subsection Fields {#device-manufacturer-analysis-fields} The following _Device Manufacturer Analysis_ fields may be available:

Field	Description
Malfunction	Select whether the device failed to meet its performance specifications or otherwise perform as intended. When this is Yes on at least one device, Vault sets the Device Report Type at the case-level to Malfunction. Based on the primary Case Device Product, Vault populates this value in the H1. Malfunction checkbox of FDA MedWatch 3500A forms.
Impact and Risk Analysis	Enter details about the risk assessment.
Remedial Action	If remedial action was taken, select the options that describe the actions. Vault maps the values to select the applicable H7. If Remedial Action Initiated, Check Type checkboxes on FDA MedWatch 3500A forms. If no options apply, select Other, and populate the Remedial Action Other field.
Remedial Action Other	When the Remedial Action is Other, describe the remedial action that was taken. Vault populates the value in the Other field of the H7. If Remedial Action Initiated, Check Type section on FDA MedWatch 3500A forms.
Initial (Corrective/Preventative) Action	Enter details of the initial corrective and/or preventive actions implemented by the manufacturer. Enter `N/A` if not yet applicable.
Corrective/Preventative Action	Enter details of any remedial, corrective, and preventative actions taken as a result of this event and your investigation.
Corrective/Preventative Action Schedule	Enter details about the schedule for any remedial, corrective, and preventative actions.
Further Investigations	Enter details of any further investigations you plan to undertake to reach the root cause. Enter `N/A` if not yet applicable.
Is root cause confirmed?	Select whether the root cause has been confirmed.
Root Cause Description and Conclusion	Enter details of your analysis of the device being reported on.
Investigation Summary and Conclusion	Enter your final comments on the incident.
Preliminary Results and Conclusions	Enter details of any preliminary analysis.
Risk assessment reviewed?	Select whether the risk assessment has been reviewed.

#### Case Product Similar Incident Subsection Fields {#similar-incident-fields} The following _Case Product Similar Incident_ subsection fields may be available:

Field	Description
Case	Select the Case with the similar incident.
Case Product	Vault populates the related Case Product.
Region	Vault populates the applicable region.
Time Period	Vault populates the applicable time period.
Start Date	Vault populates a start date for the time period using the following priority order: The earliest Onset Date across any serious Case Adverse Events The earliest Onset Date across any non-serious Case Adverse Events If no Case Adverse Events include an Onset Date, Vault populates January 1 and the current year
End Date	Vault populates a date that is one year after the Start Date.
Number of Devices on Market	Enter the annual number of devices placed in the market or devices in use.
Number of Similar Incidents	Enter the annual cumulative number of similar serious incidents.

#### Device Problem and Evaluation Codes Subsection Fields {#device-problem-fields} The _Device Problem and Evaluation Codes_ subsection captures FDA device codes for a _Device_ type of combination product constituent. Unless configured by your Admin, this section displays only for _External Products_ and _Device_ types of _Products_.

Note: If your Vault is configured for IMDRF coding, the Device Codes subsection has replaced the Device Problem and Evaluation Codes section.

Field	Description
Device Problem	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 Problem codelist is compliant with the FDA DPC code type.
Evaluation Method	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 Evaluation Method codelist is compliant with the FDA EMC code type.
Evaluation Result	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 Evaluation Result codelist is compliant with the FDA ERC code type.
Evaluation Conclusion	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. The Evaluation Conclusion codelist is compliant with the FDA ECC code type.

#### Assessments Subsection Fields {#assessment-fields} The following _Case Assessment_ fields in the _Medical Assessments_ section may be available:

Field	Description
Case Product	Vault populates a link to the related Case Product.
Product Type	Vault populates the type of Product: 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
Event (LLT)	Vault populates a link to the related Case Adverse Event.
Expected (status)	Vault indicates whether the Expected field was Vault-calculated or manually overwritten. Unless configured by your Admin, users in the Intake and Data Entry roles cannot edit this field.
Expected	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.
Listedness (Core)	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.
Listedness (status)	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.
Reaction Recurrence	Select the option that best describes whether the adverse event recurred. Note: Selecting 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.
First Dose Latency	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.
Last Dose Latency	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.
Dechallenge	Vault calculates Dechallenge values.
Dechallenge Override	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.
Potential PQC	During assessment generation, Vault populates this field with Yes if the Type on the Case Adverse Event is Product Quality Complaint. On manually created assessments, select Yes if the Inbox Item included any Product Quality Complaint types of Medical Events, indicating a product has a potential PQC.
Complaint Intake ID	If you send the PQC to a Quality Vault using the Quality-Safety Connection, Vault populates this field with the ID of the corresponding Complaint Intake in the Quality Vault.
Rank	To order the list of assessments by rank, enter a rank number. Ranked records display in ascending order on the Case. Case Assessments ranked as 1 correspond to the primary assessment. If you change an assessment to rank 1, Vault updates the rank of the previous primary assessment to 2.
Assessment Tag	Vault tags Case Assessments that meet the applicable criteria with SUSAR or SAE.
Blinding Type	Identifies whether a clinical trial study Case Assessment is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Assessments, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Assessment Results Subsection Fields {#case-assessment-result} The following _Case Assessment Result_ fields in the _Medical Assessments_ section may be available:

Field	Description
Case Assessment	Vault populates a link to the Case Assessment.
Source Type	Select the source of the assessment. For auto-generated Case Assessment Results, Vault assigns a Source Type.
Source (Text)	If none of the Source Type options apply, enter a description of the source of the assessment.
Method of Assessment	Select the option that best describes the method of assessing the case.
Method (Text)	If none of the Method of Assessment options apply, enter a description of the method of assessment.
Assessment Result	Vault may populate this field or you can select the option that best describes the result of the assessment.
Result (Text)	If none of the Assessment Result options apply, enter a description of the result of the assessment.
Causality Established	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.
Assessment Result (Override)	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.
Blinding Type	Identifies whether a clinical trial study Case Assessment Result is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Assessment Results, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Expectedness Subsection Fields {#expectedness-section} The following _Case Assessment Expectedness_ fields in the _Medical Assessments_ section may be available:

Field	Description
Name	For Vault-generated Case Assessment Expectedness records, Vault populates a name.
Datasheet	Vault populates a link to the Datasheet.
Datasheet Document	Vault populates a link to the datasheet document in your Library.
Datasheet Type	Vault populates the type of Datasheet used to evaluate expectedness. For blinded Study Products, Vault populates this field based on the Datasheet type of the Study Product Placeholder.
Country	For Vault-generated Case Assessment Expectedness records, for local Datasheets Vault populates 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.
Expected	For Vault-generated Case Assessment Expectedness records, Vault selects Yes or No to indicate whether the Case Adverse Event MedDRA term matches a term on the type of Datasheet. 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 Datasheet.
Expected (status)	For Vault-generated Case Assessment Expectedness records, Vault indicates whether the Expected field was Vault-calculated or manually overwritten.
Based On	For clinical trial study Cases, Vault indicates whether expectedness calculations are based on the Onset date of Adverse Events or the New Info Date on the Case.
Expectedness Justification	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.
Blinding Type	Identifies whether a clinical trial study Case Assessment Expectedness record is blinded.
Blinded Reference ID	For unblinded clinical trial study Case Assessment Expectedness records, those with Unblinded as the Blinding Type, Vault populates a link to the associated blinded record.

#### Registration Subsection Fields {#registration-fields} The following _Registration_ subsection fields may be available:

Field	Description
Registration Number	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.
Product (Coded)	If the Product Registration Name on the Product Registration is available, Vault populates that value. Otherwise, Vault populates the Product Name. If the Product is part of a blinded Study, Vault blinds the value in this field.
Registration Holder/Applicant	To populate the name of the product license holder or applicant for the product license, Vault maps the Registration Holder/Applicant on the Product Registration. If the Registration Holder/Applicant is blank, Vault maps the Organization on the Product Registration.
Registration Country	Vault populates the Registration Country on the Product Registration.
Trade Name	Enter the brand name of the device. For Device-type products, Vault populates this value in the B.4.k.20.FDA.1 data element of FDA E2B(R2) files.
Blinding Type	Identifies whether a clinical trial study Case Product Registration is blinded.
Blinded Reference ID	This field will be supported for the PMDA in a future release.

#### Name Parts Subsection Fields {#name-part-fields}

Field	Description
MPID Version	Enter the version date or number for the Medicinal Product Identifier (MPID).
MPID	Enter the Medicinal Product Identifier (MPID) for the product. Since only one type of product identifier is permitted, do not enter an MPID or MPID Version if entering PhPID values.
Container Name Part	Enter the product container, if present in the Medicinal Product Name. This field is used in EMA reporting.
Device Name Part	Enter the qualifiers in the name for devices. This field is used in EMA reporting.
Form Name Part	Enter the pharmaceutical form, if present in the Medicinal Product Name. This field is used in EMA reporting.
Intended Use Name Part	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.
PhPID Version	Enter the version date or number for the Pharmaceutical Product Identifier (PhPID).
PhPID	Enter the Pharmaceutical Product Identifier (PhPID) for the product. Since only one type of product identifier is permitted, do not enter a PhPID or PhPID Version if entering MPID values.
Invented Name Part	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.
Scientific Name Part	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.
Strength Name Part	Enter the strength of the product, if present in the Medicinal Product Name. This field is used in EMA reporting.
Trademark Name Part	Enter the trademark or company, if present in the Medicinal Product Name. This field is used in EMA reporting.

#### Regional Subsection Fields {#regional-fields} For information on regional fields, see Localized Case Field Reference. ### Events Section {#events-section} Use the _Events_ section to enter information about the adverse event, including hospitalization and diagnosis details. #### Details Subsection Fields {#event-details-fields} The following _Details_ subsection fields may be available:

Field	Description
Case	Vault populates a link to the Case.
Primary	Select Yes if the adverse event is the reason for reporting the case or is most likely linked to the suspect product.
Rank	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.
Auto-Rank	Vault populates a rank based on Case values.
Seriousness	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.
Event (Reported)	Enter a description of the medical event as reported by the primary source to code the MedDRA term.
Event Country	Select the country where the adverse event occurred.
Event (Reported) - Language	If other than English, enter the language in which the primary source reported the adverse event description.
Onset	Enter the date on which the adverse event or reaction started. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable. If you select Masked as the Reason Omitted, Vault masks the Reaction Onset on CIOMS I forms.
Cessation	Enter the date on which the adverse event or reaction ended. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Duration	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.
AESI Watchlist	Vault populates this field when any Case Adverse Event matches a watchlist for Adverse Events of Special Interest (AESIs).
Severity	Select the severity of the adverse event.
CTCAE Grade	Select the Common Terminology Criteria for Adverse Events (CTCAE) grade for adverse events affecting cancer patients.
HCP Confirmed	Vault populates Yes or No to indicate whether a healthcare professional confirmed the adverse event. Vault populates this field for all adverse events, based on the Reporter Qualification specified on the initial Inbox Item. You can enter or modify this value, if needed.
Highlighted Term	Select whether the reporter highlighted the adverse event and whether they considered it serious.
Outcome	Select the outcome of the adverse event. When you add or edit an Outcome, Vault recalculates Dechallenge values on Case Assessments.
Hospitalization	Select the patient outcome with respect to hospitalization. When the Seriousness on the Case Adverse Event is Caused / Prolonged Hospitalization, this is required for FDA VAERS(R3) files.
Type	Based on the corresponding Medical Event on the Inbox Item, Vault populates Adverse Event or Product Quality Complaint (PQC).
PQC Product	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.

#### Hospitalization Subsection Fields {#event-hospitalization-fields} The following _Hospitalization_ subsection fields may be available:

Field	Description
Hospital Admission Date	Enter the date the patient was admitted into the hospital. Use the calendar to select the date or enter the date manually.
Hospital Discharge Date	Enter the date the patient was discharged from the hospital. Use the calendar to select the date or enter the date manually.
Days Hospitalized	Enter the number of days the patient was hospitalized. This is required for FDA VAERS E2B(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Evaluated/Treated At	Select the type of facility where the patient was evaluated or treated. This is required for FDA VAERS E2B(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Hospital Name	Enter the name of the hospital. This is required for FDA VAERS E2B(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Hospital City	Enter the city where the hospital is located. This is required for FDA VAERS E2B(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Hospital State	Enter the state where the hospital is located. This is required for FDA VAERS E2B(R3) files. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.

#### Diagnosis Subsection Fields {#event-diagnosis-fields} The following _Diagnosis_ subsection fields may be available:

Field	Description
Symptom/Diagnosis	Select whether the adverse event is a symptom or a diagnosis.
Diagnosis	To associate an adverse event symptom to a diagnosis, select a Case Diagnosis, which are created by medical reviewers.

## Patient Page {#patient-page} Use the _Patient_ page to enter details about the patient. ### Family {#family} The following field may be available:

Field Description

Field	Description
Parent Information	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.

Parent Information

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.

### Child Information {#child} If you select the _Pregnancy_ checkbox, the _Child Information_ section appears so you can capture details about an infant born from a tracked pregnancy _Case_ when there was no adverse event in the infant. ### Drug History Section Fields {#drug-history} The _Drug History_ section captures details about each product reported in the patient's drug history. The following fields may be available:

Field	Description
Drug Name (Reported)	Enter the name of the product, as reported by the source. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
WHODrug	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.
UMC MPID	Vault displays the UMC Medicinal Product Identifier (MPID) for the product. After coding the WHODrug product code, Vault displays this field and populates the selection from the WHODrug dictionary.
IDMP MPID	Vault displays the IDMP Medicinal Product Identifier (MPID) value for the product. After coding the WHODrug product code, Vault displays this field and populates the IDMP MPID from the selected product.
Version	Based on the selection from the WHODrug dictionary, Vault populates the WHODrug version for the MPID.
Product Type	Select the type of product.
Age at Vaccination	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.
Start Date	Enter the date and time when the product was first administered. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
End Date	Enter the date and time when the product was last administered. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Indication (LLT)	Enter the reported term for the drug history product use indication to code the MedDRA term.
Indication (Reported)	Enter a text description of the drug history product use indication. Vault does not support this field for E2B import or export or any type of report generation.
Reaction (LLT)	Enter the reported term for the reaction to the drug history product to code the MedDRA term.
Reaction (Reported)	Enter a text description of the reaction to the drug history product. Vault does not support this field for E2B import or export or any type of report generation.

#### Name Parts Subsection Fields {#drug-history-name-parts} When you create _Case Drug History_ records, you can add [name part][13] information. #### Drug History Substance Subsection Fields The following _Drug History Substance_ subsection fields may be available:

Field	Description
Case Drug History	Vault populates a link to the parent Case Drug History.
Strength (Number)	Enter the substance strength. If the strength is a range, enter the lowest number in the range.
Strength (Unit)	Select the substance unit of measurement.
Substance Name	Enter the substance name, as reported.
TermID	Enter the substance TermID.
TermID Version	Enter the substance TermID Version or Version Date.

### Medical History Section Fields The _Medical History_ section captures details about each event reported in the patient's medical history. The following fields may be available:

Field	Description
Condition/Procedure	Enter the reported condition or procedure to code the MedDRA term.
Start Date	Enter the date the medical condition started. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Continuing	Select whether the medical condition is currently ongoing. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
End Date	Enter the date the medical condition stopped. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Family History	Select whether another family member experienced the same medical condition.
Illness at Vaccination?	Select whether the illness, condition, or symptom was present at or around the time of vaccination.
Comments	Enter any additional relevant information about the medical condition.

### Test Results Section Fields {#test-result-section} The _Test Results_ section captures details about the patient's test results. The following fields may be available:

Field	Description
Test Name (Reported)	Enter the reported term for the test performed to code the MedDRA term.
Test Date	Enter the date and time when the test or procedure was performed. Use the calendar to select the date or enter the date manually. If the source report omits this information, select a Reason Omitted to describe why the information is unavailable.
Test Result	Optionally, select a qualifier, such as "Less than" (<). In the first field, enter a number. In the second field, select the unit of measurement. When you enter a custom unit of measurement, the unit also appears in the Result (Unit) Text field.
Result (Text)	Enter a description of the test result.
Result (Unit) Text	Enter a description of the test result unit. Vault populates this field if a custom Test Result (Unit) unit of measurement is entered.
Result (Code)	Select a code to describe the test result.
Normal High Value	Enter the highest value in the normal range for the test. This value is usually published by the laboratory providing the test result.
Normal Low Value	Enter the lowest value in the normal range for the test. This value is usually published by the laboratory providing the test result.
Comments	Enter any relevant comments from the reporter about the test result.
More Information Available	Select whether the sender has more information about the test result.
Include Result in Narrative?	Select No to exclude this result from the generated rules based narrative, if applicable to your Admin's configuration.

### Causes of Death Section Fields {#causes-death} The following _Causes of Death_ section field may be available:

Field	Description
Cause (Reported)	Enter the reported cause of death to code the MedDRA term.

### Diagnoses Section Fields {#case-diagnoses} The following _Diagnoses_ section fields may be available:

Field	Description
Name (MedDRA)	Enter the reported term for the case diagnosis to code the MedDRA term.
Name (Reported)	Captures a text description of the diagnosis or reclassification of the adverse event. Vault does not support this field for E2B import or export or any type of report generation.

## Assessment Page {#assessment-page} Use the _Assessment_ page to review the medical timeline and enter narrative and [medical assessment][11] details. ### Narrative Section Fields {#narrative} Use the _Narrative_ section on the _Case_ to access the generated narrative document and capture additional comments from both the reporter and sender.

Field	Description
Reporter's Comments	Enter the reporter's comments on the causality assessment, diagnosis, or other relevant topics.
Company Comments	Enter the company's assessment of the case, which can be used to describe disagreement with or alternatives to the reporter's assessment.
Case Narrative	Vault populates a link to the narrative document, which is generated when you create the Case. To open the narrative document, select the link.
Narrative Preview	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]`.
Narrative Generation Status	In Vaults using Veeva AI for Safety, Vault updates this field to indicate the status of the Narrative Agent.

## Activities Page {#activities-page} Use the _Activities_ page to review: * Conformance validations * Checklists * Action items * Transmissions, including inbound transmissions ## References Page {#references-page} Use the _References_ page to refer to information and documents related to the _Case_. ### Localized Cases Section {#localized-cases-section} This section links to related _Localized Cases_ and provides details about the: * _Localization_ * _Localization Scope_ * _Lifecycle State_ * _Due Date_ * _Local Awareness Date_ ### Related Cases Section {#case-relationship} Use the _Related Cases_ section to link to each related _Case_ through _Case Relationship_ records. The following fields may be available:

Field	Description
Related Case	Select the related Case.
Related Case Identifier	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.
Link Reason	Select a reason for linking the Related Case to the Case.
Retransmit	This field controls whether Vault includes linked reports in outbound E2B transmissions for a Case. To populate the UID of related Cases in E2B transmissions, select Yes.

### Documents Section {#documents-section} In the _Document_ panel, complete the attachment and literature document fields in the [_General_][15] and [_Case_][16] sections. #### General Subsection Fields {#general-section} The following _General_ subsection fields may be available:

Field	Description
Name	When you save a document, Vault generates a document name using Vault's naming conventions for the associated document type.
Title	Enter a descriptive name for the document.
Type	Vault populates the document type selected during upload, which should be Case.
Subtype	Vault populates the document subtype selected during upload, which should be Source.
Classification	Vault populates the classification selected during upload, which should be Attachment or Literature.
Version	Vault populates the document version number.
Organization	Select the Organization associated with the Case.
Document Link	Vault populates a value that uniquely identifies the source of this document's content, such as a Vault document's Global ID. Optionally, enter an identifier.
Document Link Version	Vault populates 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.
Lifecycle Stage	Vault populates the document's Lifecycle Stage.
Lifecycle State Stage ID	Vault populates the document's Lifecycle State Stage ID.
Case Access Group	Vault populates the assigned Case Access Group inherited from the associated Case.
Tags	Vault populates applicable document tags.

### Case Fields {#case-section} The following document fields may display in either or both of the _Attachment_ and _Literature_ document types:

Field	Description
Case	When you add the document to a Case, Vault populates a link to the Case.
Inbox Item	When you create an Inbox Item from a document, Vault populates a link to the Inbox Item.
Inbound Transmission	When a document was received from an Inbound Transmission, Vault populates a link to the Inbound Transmission.
Retransmit	Select Yes to include an attachment in E2B transmissions.
Description	For attachments, enter a description of the document. The character limit for this field is 1,500, including spaces.
Description(continue)	For attachments, if the description exceeds the Description character limit, continue the description in this field.
Literature Classification	For literature, select the classification.
Publication Country	For literature, select the country in which the literature was published.
Reference	For literature, enter the citation for the literature reference.
Reference (reason omitted)	For literature, if the citation is unavailable, select a Reason Omitted to describe why the information is unavailable.
Blind Protection	Select whether to enable blind protection for the document. If the document contains sensitive unblinded data, select On to enable blind protection on the document. With this setting, only authorized users can view the document.
Product	Based on the Organization on the document, you can link a Product to the document.
Study	Based on the Organization on the document, you can link a Study to the document.
Attachment Type	For attachments, select whether the document is an over-the-counter (OTC) carton image. When sending FDA E2B(R2) or FDA FAERS E2B(R3) transmissions for a Case with OTC drugs through an AS2 Connection, select FDA Carton Attachment.

### System Section {#system-section} The _System_ section provides additional information, some of which is conditional based on the type of case, such as those with follow-up information or with device-type _Case Products_.

Field	Description
Lifecycle	Vault populates the lifecycle of the Case.
Lifecycle State	Vault populates the lifecycle state of the Case.
Locked By	Vault populates the user who manually locked the Case from editing. 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.
Locked Date	Vault populates the date when the Case was locked.
Created By	Vault populates the creator of the Case.
Created Date	Vault populates the date when the Case was created.
Last Modified By	Vault populates the latest modifier of the Case.
Last Modified Date	Vault populates the date when the Case was last modified.
Organization	Vault populates the Organization related to the Case.
Access Group	Vault populates the assigned access group. Note: If details change, authorized users can run the Calculate Case Access Group action to recalculate this value. We recommend limited use of this action as it uses significant resources.
MedDRA Version	Vault populates the version of the MedDRA dictionary that was used to code the Case.
Source MedDRA Version	Vault populates the version of the MedDRA dictionary that was used to code the Case initially.
Validation Status	Vault displays the result from Case and Submission validations. The Validation Status field may be: 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. Note: You cannot run the Submit to Gateway action if the Validation Status is Hard Fail. Vault will not run auto-submission if the Validation Status is Fail or Hard Fail.
Case Reportability	To assist in prioritizing Cases, Vault populates the reportability of a Case after you run any of the following actions: 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.
Case Expectedness	Vault populates the Expected value on the primary Case Assessment. This indicates whether the primary Case Adverse Event matches a term on the relevant product family, product, local, study, and study product Datasheets. 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 Datasheet. You can select a different option to overwrite the calculated value. Once overwritten, Vault stops syncing this field with the Expected value on the primary Case Assessment.
Listedness (Core)	Vault populates the Listedness (Core) value on the primary Case Assessment. This indicates whether the primary Case Adverse Event matches a term on the Datasheet for the Study, Product, or Product Family. 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 or study core Datasheet. You can select a different option to overwrite the calculated value. Once overwritten, Vault stops syncing this field with the Listedness (Core) value on the primary Case Assessment.
Report Type	Select the method by which the primary source reported the adverse event.
Initial Case	On follow-up Cases, Vault populates a link to the applicable original Case.

[1]: #product-fields [2]: #indications-fields [3]: #dosages-fields [4]: #combo-fields [5]: #substance-fields [6]: #substances-fields [7]: #device-fields [8]: #device-code-fields [9]: #device-incident-report-fields [10]: #device-manufacturer-analysis-fields [11]: #assessment-fields [12]: #registration-fields [13]: #name-part-fields [14]: #regional-fields [15]: #general-section [16]: #case-section [17]: #device-problem-fields [18]: #similar-incident-fields