Enter Case Data

Learn how to perform Case data entry and use the sections and fields on the Case page.

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Sections in This Article

Note Depending on your Admin's configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization's business processes for guidance.

After running the Promote to Case action, all data entered on the source Inbox Item or AER is copied over to the appropriate field on the Case and Case child records.

Note that picklist field values are accent-sensitive; entering a value with an accent prioritizes results with accents.

Details Section

Use the Details section to specify general information about the Case.

  • Initial Case Details Section
    Initial Case Details Section
  • Follow-Up Details Section
    Follow-Up Details Section
Field Description
Case Number The system generates a Case Number and populates this field when a Case is created.
You cannot edit this field. Outside of Edit mode, hovering over the Case Number link displays the UID and Worldwide UID.
UID

This field appears when you hover over the Case Number.

The UID is a system-generated E2B-compliant unique identifier that is composed in the following format: {Country}-{Organization UID Code}-{Case Number}
where:
  1. Country: The two-letter ISO country code for the Case country. The system first attempts to use the Country on the primary Reporter-type Case Contact. If the reporter country is unavailable, the system uses the Event Country on the primary Case Adverse Event.
    When the country being used for the UID changes, the system automatically updates the UID and Worldwide UID to match the new country code. This behaviour only applies to initial Cases.
  2. Organization UID Code: The value in the Organization UID Code field for the Organization associated with the Case, if available.
  3. Case Number: The system-generated value from the Case Case Number field.
For initial Cases, the system re-evaluates the UID when the following data changes:
  • Country on the primary Case Adverse Event
  • Country on the primary Reporter-type Case Contact

Note The system does not update the UID for Imported Cases or Follow-up Cases.
Worldwide UID

This field appears when you hover over the Case Number.

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

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

Note Once the Worldwide UID is populated on a Case, it does not change even if the Case UID is updated.
Receipt Date (Required) The date the event was first reported. This date starts the regulatory clock in calculating expedited reporting (for example, 7-day or 15-day reports).
Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. The time is optional.
Initial Receipt Date The Receipt Date entered on the AER or Inbox Item becomes the Initial Receipt Date upon Case promotion.
This is a lookup field that appears for Follow-up Cases only. Because this is a lookup field, if the Receipt Date on the original AER or Inbox Item changes after Case promotion, the audit trail on the referenced object does not reflect the change.
New Info Date The latest date when additional information was received about the case.

Use the calendar to select the date or enter the date manually. You must specify the year, month, and day at a minimum. Time is optional.

There can be only one New Info Date per Case version. If you overwrite this field with a new date, any previously recorded New Info Dates will appear in the audit trail.
Report Type (Required) The method in which the adverse event was reported by the primary source.
Select the appropriate report type.
Due Date The system calculates the Case reporting due date and populates this field using the seriousness criteria, expectedness, and watchlist tags. If the Case is re-assessed and these criteria change, the system automatically updates the due date.
To learn more, see Reporting Rule Parameter Reference.
Watchlist Tags The system automatically populates this field using causality assessments on primary Case Assessment Results.
To learn more, see How Case Watchlist Tags and DMEs are Assigned.
Event (PT) The MedDRA Preferred Term (PT) coded on the primary Case Adverse Event.
If the Case Adverse Event has not been coded, this field is blank. This field dynamically updates to match the primary Case Adverse Event.
Seriousness The level of impact the adverse event had on the patient.
The system automatically populates this field using the most severe seriousness criteria entered on the primary Case Adverse Event.
Listedness (Core) Whether the primary Case Adverse Event is listed on the Datasheet for the Study or Product.
The system populates this field using the Listed value in the primary Case Assessment. To override the system-calculated value, select a different option. Once overridden, the system stops syncing the Case Listedness field with the primary Case Assessment.
To learn more, see Manage Datasheets and Auto-Expectedness.
This field does not appear on page layouts by default and must be added by your Admin.
Expectedness Whether the case is expected. That is, whether the primary Case Adverse Event is listed on the relevant Product, Study, or Study Product Datasheet.
The system populates this field using the Expected value in the primary Case Assessment. To override the system-calculated value, select a different option. Once overridden, the system stops syncing the Case Expectedness field with the primary Case Assessment.
To learn more, see Manage Datasheets and Auto-Expectedness.
Relatedness
The system automatically populates this field using causality assessments on primary Case Assessment Results.
To learn more, see How Case Relatedness is Calculated.
Expedited Indicates whether the case requires expedited reporting.
The system automatically sets this field to Yes (expedited) when one of the following conditions are met:
  1. The Case has an adverse event that matches an expedited Watchlist.
  2. The Case meets seriousness criteria and contains an unexpected adverse event (serious, unexpected case).
  3. The Case contains both an adverse event that matches an expedited watchlist and an unexpected serious adverse event.
To learn more, see How Case Watchlist Tags and DMEs are Assigned.
CIOMS Remarks Enter any comments or additional information that should be populated in field 26. REMARKS on the CIOMS I form.
To learn more, see CIOMS I Generation Data Mapping.
Validation Status

The calculated Validation Result for the Case.

The following list describes the Validation Status field values:

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

Note You cannot trigger the Submit to Gateway action if the Validation Status is Hard Fail. The system will not trigger auto-submission if the Validation Status is Fail or Hard Fail.

To learn more, see Case and Submission Validation.
Suppress Submission Select this field to prevent the system from generating Submissions or including this Case in aggregate reporting.
This field can be used to track and monitor non-submittable cases (for example, pregnancy, invalid, or nullified cases).
To learn more, see Suppress Submissions of a Case Version.
Source Document The source document for the report. Use the link in this field to navigate to the source document.
The system populates this field automatically when a document is used to create the Case. Otherwise, you can select the document manually.
Version The version of the source document. Use the link in this field to navigate to the source document.
The system populates this field when you attach or create the Case from a source file.
Follow-Up Rule Select the Follow-Up Rule for the questionnaires with which the system should attempt to match the Case, Inbox Item, or AER. If you leave this field blank and select Send Follow-Up, the system uses Invalid Case (Missing Parameters) as the default value.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
This field does not appear on page layouts by default and must be added by your Admin.
Send Follow-Up Select this field to trigger the system to evaluate whether this Case, Inbox Item, or AER matches the criteria for one or more questionnaires. After running the process to generate questionnaires, the system clears this field.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
This field does not appear on page layouts by default and must be added by your Admin.
Reason Received Late Enter information to specify the reason why the case was received late.
This field does not appear on page layouts by default and must be added by your Admin.
External System UID Unique Identifier for an external system.
You can manually enter the External System UID on an Inbox Item before promoting to a Case or on the Case itself.
This field does not appear on page layouts by default and must be added by your Admin.
Initial Case When a Follow-Up Case is created, the Initial Case field for this record is automatically populated with the original Case.
This field does not appear on page layouts by default and must be added by your Admin.
Special Report Classification This field applies to Cases reportable to the PMDA only.
Select whether the Case is a Safety Measure Report or a Research Report for PMDA.
This field does not appear on page layouts by default and must be added by your Admin.
Access Group The assigned Access Group based on the Case.

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

  • Sponsor
  • Report Type
  • Country
  • Study Type
  • Study
  • Origin
  • Intake Format and Method
  • Market Segment

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

Note If Case or Access Group details change, authorized users can trigger Case Access Group recalculation manually using the Calculate Case Access Group action. We recommend limited use of this action, which takes up significant system resources.
Intake Format Displays the format the Inbox Item was created from, such as an E2B file.
This field does not appear on page layouts by default and must be added by your Admin.
Intake Method Displays the method of intake for the Inbox Item, such as Email.
This field does not appear on page layouts by default and must be added by your Admin.
Market Segment Displays the market segment associated with the study for Study Cases or the primary Product for postmarket Cases.
This field does not appear on page layouts by default and must be added by your Admin.

Device Details Section

For the Device Details section to appear, the Case must have a Case Product that is a Combination Product. Use this section to classify the report type and specify details specific to device-type Case Products. You can specify further product-specific details in the Device-type Case Product.

If this section does not appear for a Combination Product Case, your Admin must enable the Combination Products feature to make these fields appear.

Your Admin can configure your Vault for data entry for Remedial Actions and Malfunction at the Case Product Device level. Device-specific information is synced to the Case level. This is useful for Cases that involve multiple Combination Products or a Combination Product that has multiple device constituents. For more information, see Enable Remedial Actions and Malfunction for Combination Products to make these fields appear.

  • alt-text
    Initial Case Device Details
  • alt-text
    Follow-Up Case Device Details
Field Description
Device Report Type The type of device report, either Malfunction or Public Health Risk.

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

You can edit this field to include either, both, or none of the following options:

  • Malfunction
  • Public Health Risk
Device Report Type (Status) This field is set to “Auto-Calculated” when Vault Safety automatically populates the Device Report Type field based on the Case Product Device Malfunction fields.

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

Manually editing this field from “Overridden” to “Auto-Calculated” causes the system to recalculate the Device Report Type field.
Malfunction Only

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

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

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

For malfunction-only cases, you can enter "None" in the Patient Initials field and leave all other patient information blank to transmit patient characteristics as None in FDA VAERS E2B R3.
Device Follow-Up Type The reason for the follow-up on the device-type case.
Select the option that describes the reason for the follow-up. This field is not displayed for Initial Cases.
Remedial Action Whether remedial action was taken to address the adverse event.

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

Note This is a Case-level remedial action. Case Product-level Remedial Actions can be set up in the Remedial Action field of Case Product Device records.

When generating ICSRs, remedial actions are exported from the Case Product Device level, if they exist. If there are none, the Case-level remedial action in this field is exported.
Remedial Action-Other Text description of the remedial action when there is no matching option in the picklist.

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

Note This is a Case-level remedial action. Case Product-level Remedial Actions can be set up in the Remedial Action Other field of Case Product Device records.

When generating ICSRs, remedial actions are exported from the Case Product Device level, if they exist. If there are none, the Case-level remedial action in this field is exported.

This Case is Locked Section

The This Case is Locked section appears when a user manually locks a Case.

This section provides details on the date the case was locked and the user who locked it. This feature is not available by default unless your Admin configures the feature.

When a case is locked, the system prevents the users saving changes to the Case and child records until you unlock the Case. All Case child records (Case Assessment, Case Product, and so on) are locked, with the exception of Parental Case and Case Number records.

This Case is Locked Section
This Case is Locked Section
Field Description
Locked By The user who manually locked the Case from editing.
This system automatically populates this field. Users with the appropriate permissions can use this field to reassign a locked Case or clear it to unlock the Case.
Locked Date The date when the case was locked.
This system automatically populates this field.

Contacts Section

When you promote an Inbox Item or AER to a Case, the system copies the reporter and patient information to automatically create Case Contacts.

Types of Case Contacts

The following list describes the types of Case Contacts:

  • Reporter: Captures information about the person who reported the case. A Reporter-type contact is created for patients or health care professionals who are also the reporter.
  • Patient: Captures information about the patient.
  • Health Care Professional: Captures information about the health care professional who treated the patient for the adverse event that resulted in hospitalization or treatment.
  • Base Case Contact: Captures information about contacts who are not reporters, patients, or health care professionals who have information relevant to the adverse event.
  • Facility: Captures information about the facility where a vaccine dosage was administered. A Case Product Dosage can then reference a Facility record using the Administration Facility field.

    Note From Inbox Item promotion, Facility-type Case Contacts are created only through the Intake API from JSON files.

How Case Contacts are Automatically Created and Updated

In each new Case, the system creates a Reporter-type Case Contact, using information from the Inbox Item or AER contact information. The system also snapshots patient information to the Reporter-type contact when the patient is also the reporter.

If the patient was not the reporter, the system creates a separate Patient-type Case Contact. The system determines whether the patient is also the reporter using the Patient value specified in the Reporter Qualification field on the AER or Inbox Item.

Expand the following sections to learn more about how Reporter and Patient Case Contacts are created and populated.

  • When the Patient is the Reporter

    Note By default, the Qualification Controlled Vocabulary record corresponding to Patient is inactive. Your Admin must activate this record to make this Qualification option available.

    If the Reporter Qualification field is set to Patient:

    • The patient is considered the primary reporter
    • A Patient-type Case Contact is not created
    • The patient information fields are automatically populated on the primary Reporter Case Contact
      Patient Reporter
    • Any time the Patient name fields are updated on the Case, the system automatically updates the corresponding fields on the primary Reporter Case Contact
  • When the Patient is Not the Reporter
    If the Reporter Qualification field is not set to Patient:
    • The system creates a Patient-type Case Contact record, in addition to the Reporter Case Contact
    • The patient information fields are automatically populated on the Patient Case Contact
      Patient Contact
    • Any time the Patient name fields are updated on the Case, the system updates the corresponding fields on the Patient Contact. You can only have one Patient Contact per Case.

      If the AER did not specify these fields and they are later added to the Case directly, the system copies the patient name fields from the AER to create a new Patient Contact.

Add a Case Contact Record

Use the Case Contacts section to enter information about the reporting sources.

Note Each Case must have a primary Reporter-type Case Contact. As such, you cannot delete a primary Reporter record. If a primary Reporter must be deleted, you can designate a different Reporter as primary using the Rank field, and then delete the non-primary Reporter.

  1. On the Case page, expand Contacts.
  2. Select Create.
  3. In the Create Case Contact window, select the type of contact.
  4. Complete the Create Reporter page.
  5. Select Save

Result

The Case Contact is added to the Case.

Case Contact Details Fields

Different fields and Reason Omitted options are available in the Case Contact Details section, depending on the Case Contact type.

  • Reporter Details Section
    Reporter Case Contact Details Section
  • Patient Case Contact
    Patient Case Contact Details Section
  • facility contact section
    Facility Case Contact Details Section
  • healthcare-details
    Health Care Professional Case Contact Details Section
Field Description
Primary Source Indicates whether or not this Reporter record is the primary source.
If this contact is the primary Reporter, select Yes.
Qualification The contact's qualification.
Start typing for instant search or select the binoculars icon browse the available options.
Title
Enter the contact's title.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.
First Name
Enter the contact's first name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.
Middle Name
Enter the contact's middle name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.
Last Name
Enter the contact's last name.

If the contact type is Reporter or Patient, you can use the Reason Omitted field if the information is unavailable.
Facility Name Enter the name of the facility.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Facility Type Select the type of facility.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Organization Enter the name of the contact's organization.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Department Enter the name of the contact's department in their organization.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Telephone
Enter the contact's telephone number.

If the contact type is Reporter, Patient, or Facility, you can use the Reason Omitted field if the information is unavailable.
Email Address
Enter the Reporter's email address. To send automatic questionnaire emails for follow-up information, both the Email Address and Email Consent Provided are required.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Email Consent Provided Indicates whether the Reporter has consented to receive emails.
Select this field if the contact has consented to receiving email notifications or requests for follow-up information.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
Fax Enter the contact's fax number.
If the contact type is Facility, you can use the Reason Omitted field if the information is unavailable.
Best Doctor? Designates the contact as the best physician or other health care professional to contact about the adverse event.
If the contact is the best physician or health care professional to contact about the case, select the check box.
Sent to FDA? Indicates whether or not the case has already been reported to the FDA.
If the report has been sent to the FDA, select Yes.
Other Source Text
Enter any relevant additional information about the Reporter.
FDA 3500A Report Source Source of the FDA 3500A report.
Use the drop-down list to choose a value.
Additional Information
Enter any additional information that cannot be captured in the other contact fields. This field appears for Health Care Professional Case Contacts only.
Facility Military Flag Indicates whether the facility has a military designation.
If the facility is a military facility, select Yes.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Rank

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

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

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

Case Contact Address Fields

Use the Address section on Case Contacts to add address information about a reporter, patient, or facility. By default, the Address section does not appear for Health Care Professional Case Contacts.

  • Reporter and Patient Address Section
    Reporter and Patient Address Section
  • Facility Contact Address
    Facility Contact Address
Field Description
Street
Enter the contact's street address.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Street Line 2
Use this field to enter the second line of the street address.
City
Enter the name of the city where the contact resides.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
County
Enter the county where the contact resides.
State / Province
Enter the state or province where the contact resides.

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

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Country
Select the country where the contact resides.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Postal Code
Enter the contact's zip or postal code.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Regional Section

Use the Regional section on a Domestic Case to enter region-specific agency information for the NMPA (China) agency and the MFDS (Korea) agency.

  • NMPA Regional Section
    NMPA Regional Section
  • MFDS Regional Section
    MFDS Regional Section
Field Description
Additional Pregnancy Related Information Additional related patient pregnancy information.
Enter any additional information related to Case or Patient pregnancy.
NMPA Report Classification The NMPA Report Classification for Chinese Cases.
Select the appropriate NMPA Report Classification for the report from the dropdown menu.
MFDS Other Health Professional This field is only available when you select “Other Health Professional” for the reporter qualification on the Case.
Select the qualification of the reporting health professional contact from the dropdown menu.
MFDS Other Study Type This field is only available for studies.
Select the appropriate MFDS Study Type Classification for a study from the dropdown menu.
Patient Regional Section

The following fields are available on the Case Contacts Regional Section for NMPA Cases

NMPA Patient Regional Section
NMPA Patient Regional Section
Field Description
NMPA Report Source This field is required for Cases with post-market products.
Select the origin of the report from the dropdown menu.
NMPA Patient Race Select the patient's race for Chinese NMPA Cases.
Select the NMPA patient race from the dropdown menu.
NMPA Patient Nationality The patient's nationality code for Chinese NMPA cases.
Enter the Chinese nationality code for the patient in the text format “XX”. This field is required.
Organization
Enter the name of the contact's organization.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Patient Section

Use the Patient section to enter patient information, including a name or identifier, age, sex, height, weight, and medical record numbers (MRNs).

  • Case Patient Section (Non-Child)
    Case Patient Section (Non-Child)
  • When the patient's Age at Onset is less than 1.5 years, the Parent Information field becomes available to add a parent-child case link.
    Case Patient Section (Child)
    Case Patient Section (Child)
Field Description
Patient Known to Exist Whether there is a known Patient involved in the Case. This information is required for reporting obligations in certain jurisdictions.

Select this field if any of the following scenarios apply:

  • There is a referenced patient in the Case
  • There is a patient, but specific patient characteristics are not available
  • There is a patient, but the patient may not be identifiable
To learn more, see Reporting Rule Parameter Reference.
This field does not appear on page layouts by default and must be added by your Admin.
Patient Initials
Enter the patient's initials.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Name Prefix
Enter the patient's name prefix or title. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient First Name
Enter the patient's first name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Middle Name
Enter the patient's middle name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Last Name
Enter the patient's last name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Investigation MRN The unique Subject/Patient ID, Centre ID, or random number in a clinical trial.
If a clinical trial investigated the adverse event, enter the following information:
  • The patient's medical record number with a general practitioner
  • The general practitioner's record number

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

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Randomization Number The patient's randomization number from the clinical trial randomization system.
The system can automatically populate this field during a bulk unblind operation using the study participants CSV file. You can also enter this field manually.
To learn more, see Bulk Unblind a Study.
This field does not appear on page layouts by default and must be added by your Admin.
Gender
Select the patient's gender.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Height 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 numeric value. In the second field, select the unit of measurement.
Parent Information Reference to the Parent Information Case from the current (child) case. The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.
For a parent-child case, create or select the Parental Case to link it to the current Case. You must select a Case with the object type of Parental Case (parental_case__v). Add a Parental Case provides more information.
Date of Birth The patient's birth date.
Use the Calendar pop-up tool to select a date or enter the date manually. For this field to be exported to E2B Transmissions, the full date is required with year, month, and day.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Age (normalized) The normalized Age at Onset value calculated in “years”.
The system automatically calculates Age (normalized) and uses it to populate the Age at Onset field, if no value exists already.

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

Auto-Calculation

The system automatically calculates this field using the time interval between the following dates:

  1. The Case Date of Birth
  2. The Case Adverse Event Event Onset. If an Event Onset is not available, the system uses the Case Receipt Date.

    NoteIf there are multiple Case Adverse Events, the system uses the earliest event to calculate the age. For fetal adverse events, the system uses the event closest to the birth date.

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

When only partial dates are available, the system calculates the age using the first day in the month or year entered. For example, if only "2021" is entered, the date 1/1/2021 is used.

To learn more, see How Age Fields are Calculated.
Age at Onset The patient's age at the onset of the adverse event.

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

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

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

To learn more, see How Age Fields are Calculated.
Age Group The patient's age group at the onset of the adverse event, according to the following criteria:
Age Group Age at Onset
Fetus 0 weeks/days/hours/minutes old
Neonate More than 0 to less than 4 weeks old
Infant 4 weeks to less than 12 months old
Child 1 year to less than 12 years old
Adolescent 12 years to less than 18 years old
Adult 18 years to less than 65 years old
Elderly 65 years and older
The system automatically calculates this field upon Case promotion or when the Age at Onset field on the Case is updated. If you manually enter a value, and the system later recalculates this field, the field is overwritten by the auto-calculated value.

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

Auto-Calculation
The system automatically calculates the age group based on the value in the Age at Onset field and the above criteria.
To learn more, see How Age Fields are Calculated.
Age at Vaccination The patient's age at the time of being administered the primary vaccine-type product. This field is used in FDA VAERS reporting.
The system automatically calculates this field upon Case promotion or when the Case is updated. If you manually enter a value after the auto-calculation, the system retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, the system will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

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

Auto-Calculation

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

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

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

Note Both date fields must be precise to at least the day to be used for auto-calculation.
Autopsy Indicates whether or not an autopsy was performed. This field displays if the Date of Death field has a value.
Select either Yes or No from the drop-down menu.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Date of Death Enter the date when the patient was reported as deceased.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Last Menstrual Period
Enter the date when the patient last experienced a menstrual period. This field is only available if the Gender field is set to Female.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Pregnancy
Use this field to identify a case as a Pregnancy Case for tracking and capturing pregnancy information. This field is only available if the Gender field is set to Female.
To learn more, see Add a Pregnancy Case.
Pregnant at Exposure Indicates whether the patient was pregnant at the time of exposure. This field is only available if the Gender field is set to Female. This field is used in FDA VAERS reporting.
If the patient was pregnant at the time of exposure, select Yes.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Ethnicity
Select the patient's ethnicity. Start typing for instant search or use the binoculars icon to browse for the appropriate value. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Race
Select the patient's race from the drop-down list. This field is used in FDA VAERS reporting.
Specialist MRN The patient's medical record number with a specialist and the specialist's record number.
If the patient visited a specialist for the adverse event, enter the following information:
  • The patient's medical record number with a specialist
  • The specialist's record number

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

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Hospital MRN The patient's medical record number with a hospital and the hospital's record number.
If the patient visited a hospital for the adverse event, enter the following information:
  • The patient's medical record number with a hospital
  • The hospital's record number

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

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
GP MRN The patient's medical record number with a general practitioner and the general practitioner's record number.
If the patient visited a general practitioner for the adverse event, enter the following information:
  • The patient's medical record number with a general practitioner
  • The general practitioner's record number

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

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Concomitant Therapies
Select Yes or No to indicate whether the patient was being treated with concomitant therapies, such as radiotherapy, drug class, or dietary supplements, at the onset of the adverse event.
Military Status
The patient’s military status type. This field is used in FDA VAERS reporting.
Medical History Text
Enter the patient's medical history and concurrent conditions, which could not be coded as Medical History records. If there is no medical history, you can specify "None."

Note When the Medical History Text control-type field is included in your page layout, this field includes a Reason Omitted picklist. The options are limited to only those values that are valid for E2B submissions. For more information see Update the Case Page Layout for Reasons Omitted for Medical History Text.
Medical History Text (reason omitted)
If the source report omits the medical history, select the option that describes why this information is not available.

Add a Parent Case

For a parent-child case, use the Parent Information field in the Patient section to capture E2B-compliant parent information using a Parent Information-type Case.

  1. On the Case page, expand the Patient section.
  2. In the Parent Information field, select Binoculars-Icon.
  3. In the Search: Parent Information window, select Create.
  4. In the Create Case window, select Parent Information, and then select Continue.
  5. Enter the information about the parent, and then select Save.
    The system saves the parent information and adds a reference to the Parent Case in the Parent Information field.
  6. If you must enter Parent Medical History and Parent Drug History details in the Parent Case, complete the following steps:
    1. On the Case page, expand Patient.
    2. Click through the Parent Information link to get to the Parent Information record.
    3. Expand Parent Medical History & Concurrent Conditions list section and enter data records, as required.
    4. Expand Parent Drug History list section and enter data records, as required.

Result

Information added to the Parent Information Case is transmitted in section D.10 for E2B (R3) or B.1.10 for E2B (R2).

You can return to the Child Case from the Children Cases/Information section on the Parent Information Case.

Parent Information Case Fields

The following sections outline the fields available for data entry on Parent Information-type Cases.

Parent Section

Use the Parent section to enter basic parent information, including a name or identifier, age, sex, height, and weight.

Parent Information Case Parent Section
Parent Information Case: Parent Section
Field Description
Organization Organization that develops the suspect product or sponsors the study.
This field is automatically populated with the Organization from the child Case.
Parent Initials
Enter the parent's name or initials.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Parent Name Prefix
Enter the parent's name prefix or title. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Parent First Name
Enter the parent's first name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Parent Middle Name
Enter the parent's middle name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Parent Last Name
Enter the parent's last name. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Date of Birth The parent's birth date.
Use the Calendar pop-up tool to select a date or enter the date manually. For this field to be exported to E2B Transmissions, the full date is required with year, month, and day.
Age of Parent Parent's age at the onset of the adverse event in the child.
Enter a number in the first field. Then, select the age unit of measurement from the drop-down menu. When a unit other than years is selected, the age in years (normalized) value is calculated and displayed on the Parent Information Case when you save the record.
Age at Vaccination The parent's age at the time of being administered the primary vaccine-type product. This field is used in FDA VAERS reporting.
The system automatically calculates this field upon Case promotion or when the Case is updated. If you manually enter a value after the auto-calculation, the system retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, the system will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

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

Auto-Calculation

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

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

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

NoteBoth date fields must be precise to at least the day to be used for auto-calculation.
Gender
Select the parent's gender.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Last Menstrual Period
Enter the date when the parent, last experienced a menstrual period. This field is only available if the Gender field is set to Female.
Pregnancy
Use this field to identify a case as a Pregnancy Case for tracking and capturing pregnancy information.
To learn more, see Add a Pregnancy Case.
Pregnant at Exposure Indicates whether the parent was pregnant at the time of vaccination or drug exposure. This field is only available if the Gender field is set to Female. This field is used in FDA VAERS reporting.
If the patient was pregnant at the time of exposure, select Yes.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Height The parent's height.
In the first field, enter a number. In the second field, select the unit of measurement.
Weight Enter the parent's weight.
In the first field, enter a numeric value. In the second field, select the unit of measurement.
Medical History Text
Enter the parent's medical history and concurrent conditions, which could not be coded as Medical History records. If there is no medical history, you can specify "None."
Study The study the tracked pregnancy is associated with. This field appears when the Pregnancy checkbox is selected on the Parent Information Case.
The system automatically sets the Study based on the Study associated with the child Case. Otherwise, you can manually select the Study.
Study Site The study site the tracked pregnancy is associated with. This field appears when the Pregnancy checkbox is selected on the Parent Information Case.
The system automatically sets the Study based on the Study Site associated with the child Case. Otherwise, you can manually select the Study Site.
Pregnancy Information

See Pregnancy Information Section for information on the pregnancy fields available for data entry.

Pregnancy Outcome

See Pregnancy Information Section for information on the pregnancy fields available for data entry.

Parent Medical History & Concurrent Conditions Section

Use the Medical History & Concurrent Conditions section on a Parent Information Case to enter relevant medical history of the parent.

Parent Medical History & Concurrent Conditions Section
Parent Medical History & Concurrent Conditions Section
Field Description
Case Reference link to the Parent Information Case.
The system automatically populates this field.
Condition/Procedure
Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Start Date Use the calendar pop-up tool to select a date or enter the date manually.
The date when the medical condition started.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Continuing
Select Yes or No to indicate whether the medical condition is currently ongoing.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
End Date The date when the medical condition stopped.
Use the calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Family History
Select Yes or No to indicate whether another family member experienced the same medical condition.
Illness at Vaccination?
Select Yes or No to indicate whether the illness, condition, or symptom was present at or about the time of vaccination.
Comments
Enter any additional relevant information about the medical condition.
Parent Drug History

Use the Drug History section on a Parent Information Case to enter the parent’s drug history.

parent-drug-history
Parent Drug History Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Drug Name (Reported)
Enter the name of the product, as reported by the source.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
WHODrug Product code from the WHODrug dictionary.
After entering the reported drug name, select Search WHODrug to automatically populate the search query. Browse and select the appropriate product code using the WHODrug search window.
To learn more, see Code WHODrug Products.
MPID Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Version The WHODrug version for the MPID. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Start Date Use the calendar pop-up tool to select a date or enter the date manually.
The date and time when the product was first administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
End Date The date and time when the product was last administered.
Use the calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Indication (LLT) The MedDRA LLT for the product use indication.
Enter the term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Reaction (LLT) The MedDRA LLT for the reaction to the product.
Enter the term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Age at Vaccination The age of the parent at the time of vaccination.
The system recalculates and updates this field any time a field used to calculate this value is updated. If you manually enter a value after the auto-calculation, the system retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, the system will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

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

Auto-Calculation

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

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

Note Both date fields must be precise to at least the day to be used for auto-calculation.

Pregnancy Information Section

For pregnancy cases, enter information about the pregnancy and outcome in the Pregnancy Information section.

Tip For guidance on adding Pregnancy Cases, see Add a Pregnancy Case.

Case Pregnancy Information Section
Case Pregnancy Information Section
Field Description
Pregnancy Conception Date
Specify the date of conception for the parent's pregnancy. Use the calendar pop-up tool or enter the date manually.
Pregnancy Due Date
Specify the expected due date for the parent's pregnancy. Use the calendar pop-up tool or enter the date manually.
Gestation For a fetus report, enter the gestation period at the onset of the adverse event. The patient's Age at Onset must be less than 1.5 years for this field to appear.
In the first field, enter a numeric value. In the second field, select the unit of measurement.
Sponsor Pregnancy Awareness

When the sponsor or company was made aware of the pregnancy. Select one of the following options:

  • Prospective: The sponsor/company was aware of the pregnancy before the birth.
  • Retrospective: The sponsor/company was aware of the pregnancy after the birth.
Para/Parity
Enter the number of completed pregnancies beyond 20 weeks gestation (whether viable or nonviable). Note that a multiple gestation pregnancy counts as a single birth.
Gravida/Gravidity
Enter the number of pregnancies the parent has had. Note that a multiple gestation pregnancy counts as a single pregnancy.
Number of Fetuses
Enter the number of fetuses for this pregnancy.
Pregnancy Outcome

Select the option that best describes the outcome of the pregnancy:

  • Live born
  • Fetal death / stillborn
  • Miscarriage
  • Elective Termination
  • Termination for a fetal anomaly
Date of Pregnancy Outcome
Enter the date of the pregnancy outcome.
Delivery Method

Select the option that best describes the delivery method for this pregnancy:

  • Natural
  • Cesarean section
  • Medicated

Child Information Section

Use the Child Information section to capture details about the infant born from a tracked pregnancy case, when there was no adverse event in the infant.

The Pregnancy checkbox must be selected to make this section appear on the page layout.

Tip For guidance on adding different birth outcomes associated with pregnancy cases, see Add a Pregnancy Case.

Add a Child Information Case

  1. On the Case page, expand the Child Information section.
  2. Select Create.
  3. Enter information about the child in the Child Information section.
  4. Select Save.

Child Information Case Fields

The following sections outline the fields available for data entry on Child Information-type Cases.

Child Information Section

Child Information Section
Child Information Section
Field Description
Organization Organization that develops the suspect product or sponsors the study.
Select the Organization from the drop-down list.
Parent Information Reference to the parent Case from the current Child Information Case.
The system automatically populates this field when you create a Child Information Case from another Case.
Child Initials
Enter the child's name or initials.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Child Name Prefix
Enter the child's name prefix or title.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Child First Name
Enter the child's first name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Child Middle Name
Enter the child's middle name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Child Last Name
Enter the child's last name.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Date of Birth The child's birth date.
Use the Calendar pop-up tool to select a date or enter the date manually.
Child Age
Enter the child's age. Enter a number in the first field. Then, select the age unit of measurement from the drop-down menu. When a unit other than years is selected, the age in years (normalized) value is calculated and displayed on the Parent Information Case when you save the record.
Gender
Select the child's gender.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Height The child's height.
In the first field, enter a number. In the second field, select the unit of measurement.
Weight Enter the child's weight.
In the first field, enter a numeric value. In the second field, select the unit of measurement.
Hospital MRN The child's medical record number with a hospital and the hospital's record number.
You can enter multiple sets of record numbers in this field.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
GP MRN The child's medical record number with a general practitioner and the general practitioner's record number.
You can enter multiple sets of record numbers in this field.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Test Results Section

Once you save a Child Information Case, the system automatically creates Case Test Result records for you to capture the following information:

  • 1, 5, and 10 minute APGAR scores
  • Birth Outcome
  • Head Circumference

If the Case references a MedDRA version, the Test Name field on these Test Results are auto-coded, with the exception of Birth Outcome.

See Case Test Result Section for more information on the Case Test Result Fields.

Child Test Results Section
Child Test Results Section

Products Section

Use the Products section on the Case to enter information about suspect and concomitant medications, including products suspected to have an interaction. For Cases under a Study, this section label appears as Products (Study).

case-product-section
Products Section

When an Inbox Item or AER is promoted to a Case, the system copies the product information to create the primary Case Product record using the appropriate product type:

  • Company Product (Drug, Biologic, Device, Vaccine, or Company Product): If a Product from the company library was selected on the source Inbox Item or AER, then the system creates the Case Product of that type.
  • Study Product: If the Inbox Item or AER specified a Study, then the system snapshots the Study Products to the Case.
    If your Admin has preconfigured Study Arms related to the Case, the Study Products are automatically downloaded from the study arm selected in the Adverse Event Report.
  • External Product: If the Inbox Item or AER does not link to a preconfigured Product, then the product details are added as an External Product.
  • Combination Product: If a Combination Product was selected on the Inbox Item or AER, its constituents are automatically downloaded and added as separate Case Products when the Case is promoted. Each constituent Product inherits the Combination Product Drug Role.

    Tip If the Inbox Item was promoted with a constituent product in error, you can edit the Combination Product field of the Product. The related constituent products are automatically downloaded and added as separate Case Products.

Note Each Case must have a primary Case Product. As such, you cannot delete a primary Case Product record. If a primary Case Product must be deleted, you can designate a different Case Product as primary using the Rank field, and then delete the non-primary Case Product.

About Company Products

The Company Product type of Company Product is used when a product has multiple Product Type registrations to meet agency reporting requirements. When Company Product is selected, the Transmission Product Type from the Product Registration is snapshotted to the Product Globally Registered As field. Available Transmission Product Types include the following:

  • Drug
  • Biologic
  • Device
  • Vaccine
  • Nutritional
  • Cosmetic
  • OTC Drug
  • OTC Device
  • Combination Product

Note Your Vault may not be configured to display the Globally Registered As field, which is intended for Admin use only.

Add a Case Product Record

When you add a product that is already configured in the Vault Safety Product library, Vault Safety populates the product details on the Case.

  1. On the Case page, expand Products, and then select Create.
  2. In the Create Case Product window, perform one of the following actions:
    • To add a study product, select Study Product.
    • To add a company product, select Biologic, Drug, Device, Vaccine, or Company Product, depending on the product type for which the Product is configured in your vault.
    • To add a product that is not configured in the Vault Safety Product Library, select External Product.
  3. Select Continue.
  4. Complete the Create Product page.
  5. Select Save.

Note If you get an error on saving, make sure you're creating the Case Product with the same type as the Product configured in Business Admin. If the product you're adding is linked to the study associated with the Case, you must add it as a Study Product.

Note When you create a Company Product record, the sections and fields included are based on the Product Types in the associated Product Registrations. For example, the Device Information section appears only when the Company Product is registered as a device in at least one jurisdiction. Configure page layouts according to your business requirements.

Case Product Details Section

The fields that appear in the Product Details section depend on the Product type and your Vault’s configuration.

Your Admin can configure your Vault for data entry for Remedial Actions and Malfunction at the Case Product Device level. Device-specific information is synced to the Case level. This is useful for Cases that involve multiple Combination Products or a Combination Product that has multiple device constituents. For more information, see Enable Remedial Actions and Malfunction for Combination Products to make these fields appear.

  • alt-text
    Study Product
  • alt-text
    Drug, Biologic, or Company Product
  • alt-text
    Vaccine Product
  • alt-text
    Device Product and Combination Product
  • alt-text
    External Product
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Study
Select the Study that the Study Product is associated with. The system automatically populates this field with the Study associated with the Case. This field appears for Study Products only.
To learn more, see Manage Studies.
Primary Indicates whether the product is the primary product on the case.
If the product is the key suspect product of interest, select Yes. You cannot make an External Product primary.
Rank

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

Products ranked as 1 correspond to the primary product role.

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

This field does not appear on page layouts by default and must be added by your Admin.
Drug Role Select the characterization of the drug role in the adverse event as provided by the primary reporter or sender.

A valid Individual Case Safety Report (ICSR) must include at least one Case Product with a drug role of either Suspect, Interacting, or Drug Not Administered. For Device-type Case Products to appear on generated FDA MedWatch 3500A reports, the Drug Role must be Interacting or Suspect.

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

Drug Role Option Description
Suspect Identifies a product suspected to have contributed to the adverse event.
Interacting Identifies a product suspected to have an interaction with another product.
Concomitant Identifies a product taken by the patient at the time the reaction was observed.
Drug Not Administered Identifies a product that was not administered, but must be reported. For example, in a clinical trial setting or due to a product administration error.
Similar Device Identifies a US-marketed product (such as a vaccine) that contains the same or similar device as the suspect product for which a malfunction was reported. This option is used in FDA VAERS submissions for scenario 10 (a malfunction combination product with a similar device).
Treatment Identifies products used to treat the adverse event. This drug role is for tracking purposes only and does not appear on generated regulatory reports.

Note For Combination Products, if the Drug Role is changed on a constituent Product, the change is applied to all constituents.
Product (Reported) Enter the name of the product, as reported by the source.

Note When adding unblinded or open label Study Products to a Case, if the Product (Reported) field is blank, the Study Product Name is mapped to field. The system does not override the field if it is populated.
Product A link to the Product, as configured in the Product Library.
Select the Product from the drop-down menu. The options are filtered by the Products in the Product Library under the Case Organization.
To learn more, see Manage Products.
Combination Product The combination product for which this product is a product constituent. This field appears for Combination Product Constituents only.

The system automatically populates this field when a Combination Product was selected as the product in the source Inbox Item or AER.

When adding or editing a Product record to include a Combination Product, Related constituent products are automatically downloaded and added 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.

To learn more, see Manage Combination Products.
Trade Name The brand name of the device.
For Device-type products, this field is used in report generation for FDA E2B(R2) (B.4.k.20.FDA.1).
Product Code
For devices only, enter the product code classification.
Vaccine Type The type of vaccine. This field is used in FDA VAERS reporting.
The following options are available by default:
  • Live Attenuated Viral
  • Inactivated
  • Subunit
  • Toxoid
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Product Registration A link to the Product Registration record, as configured in the Product Library.
If the product registration details are already configured in the Product library, select the Product Registration record.
To learn more, see Add Product Registration Details.
Combination Product Registration A link to the Combination Product Registration record, as configured in the Product Library.
If the product registration details are already configured in the Product library, select the Product Registration record.
To learn more, see Combination Product Registrations.
Country Obtained
Select the country where the product was obtained.
WHODrug Product code from the WHODrug dictionary. This field appears for External Products only.
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.
To learn more, see Code WHODrug Products.
MPID Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Version The WHODrug version for the MPID. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Action Taken
Select what action was taken with the product as a result of the adverse event. Use the binoculars icon to search for Action Taken or enter the information manually.
Remedial Action Whether remedial action was taken to address the adverse event.

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

  • Inspection
  • Modification/Adjustment
  • Notification
  • Other
  • Replace
  • Recall
  • Relabelling
  • Repair
  • Patient Monitoring

This field populates the applicable H7. If Remedial Action Initiated, Check Type checkboxes in the FDA 3500A form.
Remedial Action Other Text description of the remedial action when there is no matching option in the picklist.

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

This field populates the H7. If Remedial Action Initiated, Check Type > Other field in the FDA 3500A form.
Malfunction Whether the device failed to meet its performance specifications or otherwise perform as intended.

Select Yes or No from the picklist.

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

Based on the primary Case Device Product, this field populates the H1. Malfunction checkbox in the FDA 3500A form.
Gestation Exposure The patient's Age at Onset must be less than 17 months (1.5 years) for this field to appear.
Enter the gestational age at the time of the earliest exposure. Enter a numeric value in the first field and select a unit of time in the second field.
Additional Information Additional information relevant to the product and its usage.

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

If you cannot describe the additional information with any of these options, type the text in the Other Additional Information field.
Other Additional Information
If none of the options in the Additional Information list apply, use this field to enter any additional product information.
Expiration Date The product expiry date.

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

The original Expiration Date field does not accept partial dates. However, the Expiration Date control, introduced in the 22R1 release, accepts partial dates with a minimum precision of the year.
Cumulative Dose
The total cumulative dose administered until the first sign of an adverse event.
Auto-Calculation

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

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

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

To learn more, see How Cumulative Dose is Calculated.
External Product Type
Select the product type for the external product to ensure product fields specific to product types are displayed. For example, certain fields only appear when you select Vaccine as the External Product Type. This field appears for External-type Case Products only.
This field does not appear on page layouts by default and must be added by your Admin.
Globally Registered As

Displays the Transmission Product Type from the Product Registration. The options include the following:

  • Drug
  • Biologic
  • Device
  • Vaccine
  • Nutritional
  • Cosmetic
  • OTC Drug
  • OTC Device
  • Combination Product

This field does not appear on page layouts by default and must be added by your Admin.
Blinded Name
The system populates this field automatically using the Blinded Name (Study Product Placeholder) from the Inbox Item Study Product field.
This field does not appear on page layouts by default and must be added by your Admin.

Dosages Section

Use the Dosages section to add, edit, or delete dosage and route of administration regimens for a Case Product. By default, this section does not display for Device-type Case Products or Study Products associated with a double-blinded Study.

When there are no Dosage records, the Case Product Dosage section control appears blank. To create a Dosage, select Edit on the Case Product page.

To create additional dosages for a Case Product, select the Add Dosages button. After saving the page, the system displays dosages in order of the earliest to latest First Admin Date.

Note You must save the Case Product page after adding 10 dosage entries. When there are 11 or more dosages, use the left and right arrows to move through the pages.

  • Case Product Dosage (Non-Vaccine)
    Case Product Dosage (Non-Vaccine)
  • Case Product Dosage (Vaccine)
    Case Product Dosage (Vaccine)
Field Description
Dose The amount of product administered at one time.
Enter the (numeric) dose value in the first field. Select the unit of measure for the dose from the picklist, or create a custom entry.
Frequency Enter how often the dose was administered. Once you save the page, the system will calculate and display an E2B-compliant description of the values. For example, 4 times per day (.25 days).
  • To enter a specific time interval, select either the first or second option depending on the preferred format.
  • If the dosage regimen is not specific to a time interval, or the exact frequency is unknown, select the third option and specify whether the regimen was "Cyclical" or "As Necessary".

    If only the total product dosage is provided, select "Total" in the third option. For example, if a patient took 100mg of a drug in total, you should enter 100mg in the Dose field and select "Total" in the Frequency field.
First Admin Date
Enter the date and time (if available) when the product was first administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Last Admin Date
Enter the date and time (if available) when the product was last administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Duration Combined number and unit field to capture the overall duration of time that the product was administered to the patient.
Auto-Calculation

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

  • First Admin Date
  • Last Admin Date

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

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.
Batch/Lot Number
Enter the batch or lot number for the medicinal product.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Expiration Date The product expiry date for the batch/lot number.

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

Note You can enter a full date or a partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Dose Form Description of the pharmaceutical dose form.

Select an option from the picklist, or create a custom entry.

Vault Safety supports a selection of dose form terms, including terms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) and the Medicines and Healthcare products Regulatory Agency (MHRA).

Encoded dose forms in E2B reports received and imported into Vault Safety will be mapped using these dictionary entries, including E2B(R2) codes received from the MHRA.
Patient RoA Route of administration code for the patient.
Select an option from the picklist, or create a custom entry.
Parent RoA Route of administration code for the parent for a parent-child or fetus report.
Select an option from the picklist, or create a custom entry.
Administration Facility The facility where the vaccine was administered. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.
If the product is a vaccine, select the facility that administered the dosage. The options available in this list correspond to the Facility-type Case Contacts added to the Case.
Anatomical Site The vaccine anatomical approach site. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.
Select the anatomical site to which the dosage was administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Dose Number in Series
Enter the dose number in the series. This field is available only when the Case Product type is Vaccine or Company Product. This field is used in FDA VAERS reporting.
Dose Text
Enter a description of the dosage when there is information that cannot be captured in the other Dosage fields.

Indications Section

Use the Indications section to specify the reported and MedDRA coded usage for the product in treating a medical condition.

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

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Indications Section
Field Description
Indication (Reported) The indication for product use.
Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Device Information Section

Use the Device Information section to enter details about Device-type Case Products. By default, this section only displays for External Products and Device Products. When the Case includes a Company Product, this section displays if the Product Registration Transmission Product Type is set to Device.

device information section
Device Information Section
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.
Unique Identifier
Enter the unique identification code assigned to the medical device by the manufacturer.
Operator of Device The operator using the medical device.
Select the type of operator from the picklist. By default, the options in this picklist are:
  • Health Professional
  • Lay Person
  • Other
Operator of Device (Other) You must select Other in the Operator of Device field for this field to appear.
Enter a text description of the medical device operator if the Operator of Device picklist does not contain a suitable option.
Single Use
Select Yes or No to indicate whether the medical device is labeled for single use.
Reprocessed/Reused
Select Yes or No to indicate whether the single-use medical device was reprocessed and used for a subsequent application. This field populates box 7b. in the FDA 3500A form.
Reprocessor
Enter the name and contact information of the contact who reprocessed the medical device. This field populates box 7b. in the FDA 3500A form.
Date Implanted Enter the date when the medical device was implanted in the patient.

Note You can enter a full date or a partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Date Explanted Enter the date when the medical device was removed from the patient.

Note You can enter a full date or a 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.

Note You can enter a full date or a partial date in this field. A partial date is one that specifies only the year or both the year and the month.
Device Available
Select Yes or No to indicate whether the device is available for further evaluation.
Device Evaluated
Select Yes, No, or Not Returned to Manufacturer to indicate whether the device has been evaluated by the manufacturer. This field populates Section H Box 3. Device Evaluated by Manufacturer on the FDA 3500A form.
Manufacture Date
Enter the date when the device was manufactured.
Device Usage Type The product usage type for the device-type product.
Use the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.
Device Age The age of the device.
In the first field, enter a numeric value. In the second field, select a unit of time from the drop-down menu.
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.
This field populates Section H Box 9. If action reported to FDA under 21 USC 360i(f), list correction/removal reporting number on the FDA 3500A form.
Additional Device Manufacturer Narrative Enter any additional information, evaluation, or clarification of information previously entered.
This field populates Section H Box 10. Additional Manufacturer Narrative on the FDA 3500A form.

Case Product Device Code

The Case Product Device Code section captures the harmonized FDA/IMDRF codes for device-specific adverse events.

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Case Product Device Code Section
Field Description
Case Product The device for which you want to assign a problem code.
Select the binoculars icon to search for the device or start typing for instant search.
Device Code Type Displays the seven IMDRF annex names for the categories of device codes.
Select an option from the picklist.
Device Code After the Device Code Type field is populated, search for and select the device code from the picklist. The available options are dependent on the Device Code Type selected and the active IMDRF dictionary version.

Note If populated, and after saving the Case, the Device Code field includes a hyperlink 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

Device Problem and Evaluation Codes Section

The Device Problem and Evaluation Codes section captures FDA device codes for a Device-type combination product constituent. By default, this section only displays for External Products and Device Products.

Note As of the 22R2.3 release (September 29, 2022), you can complete coding with the IMDRF Coding Dictionary. If your Vault is configured for this, the Case Product Device Code section has replaced the Device Problem and Evaluation Codes Section. See Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions for more details on this feature.

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Device Problem and Evaluation Codes Section
Field Description
Device Problem The device problem code. The Device Problem codelist is compliant with the FDA DPC code type.

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

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.
Evaluation Method The device evaluation method code. The Evaluation Method codelist is compliant with the FDA EMC code type.

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

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.
Evaluation Result The manufacturer evaluation result code. The Evaluation Result codelist is compliant with the FDA ERC code type.

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

Select the binoculars icon to search the language corresponding with the medical device usage or start typing for instant search.
Evaluation Conclusion The manufacturer evaluation conclusion code. The Evaluation Conclusion codelist is compliant with the FDA ECC code type.

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

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

Blinding Details Section

The Blinding Details section describes the blinding settings active on a Case Product. This section is informational and read-only. By default, this section only displays if the associated Study associated with the Case is double-blinded. In addition, your Admin must have enabled Product Masking Selection for Study Products.

Manage Case Blinding provides information about unblinding Cases.

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Blinding Details Section
Field Description
Study Blinded Indicates whether blinding is enabled on the Study associated with the Case Product.

The values that appear in this field depend on your Admin’s configuration. The available values are:

  • Open Label or blank
  • Blinded or Yes
  • Unblinded or No

The system automatically populates this field.
Case Blinded Indicates whether blinding is enabled on the Case.

The system automatically populates this field.

Note During unblinding, the system automatically sets this field to Unblinded when at least one Study Case Product is set to Unblinded and there are no Study Case Products set to Blinded.
Blind Protection Indicates whether Blind Protection is active for the Study Product. While a Case is blinded, the value in this field is blank. Blind protection becomes active after unblinding the Case.
The system automatically populates this field.
To learn more, see Manage Case Blinding.
Masking Indicates whether the Study Product is currently blinded, unblinded, or open label.
The system automatically populates this field.

Registration Section

Use the Registration section to add license and registration details for a Case Product. By default, this section does not appear for blinded Study Products.

If the registration details are already configured in the Product library and you select that Product Registration in the Case Product Details section, the system automatically populates data in the Registration section.

The following sections are only available for PMDA (Japan) Domestic Case processing:

  • Case Product Registration
  • PMDA Reporting Information
  • Case Comment
  • Study Product Registration Section
    Study Product Registration Section
  • Drug, Biologic, or Vaccine Product Registration Section
    Drug, Biologic, or Vaccine Product Registration Section
  • Device Product Registration Section
    Device Product Registration Section
  • External Product Registration Section
    External Product Registration Section
  • PMDA Reporting Information Section
    PMDA Reporting Information
Field Description
Product The Product reference to which this Product Registration applies.
The system automatically populates this field. By default, this field only appears for open or single-blinded Study Products.
Product Type The Case Product record type.
The system automatically populates this field, and it is read-only.
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 in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).
Registration Holder/Applicant
Enter the name of the product license holder or applicant for the product license.
Compounding Type
If the product is a compounded product, specify the type. Start typing for instant search or select the binoculars to browse all available options.
MPID
Enter the Medicinal Product Identifier (MPID) for the product. Note that you can specify only one type of product identifier. Do not specify a MPID if you have entered a PhPID.
MPID Version
Enter the version date or number for the Medicinal Product Identifier (MPID).
Product Registration
If an admin has configured a Product Registration, select the appropriate Product Registration, and then save the page. Fields preconfigured on the Product Registration are automatically populated on the Case Product Registration upon saving. By default, this field only appears for open or single-blinded Study Products.
Product (Coded) The product name from the product registration.
If the Product Registration Name is available, Vault Safety automatically populates this field using that name. Otherwise, this field is populated with the Product Name. If the Product is part of a blinded Study, the value in this field is blinded.
Registration Country
Select the country where the product is registered and authorized. This field is required when there is a value in the Registration Number field.
Combination Type
If the product is a combination product, select the combination type. This field is used in FDA VAERS reporting.
PhPID
Enter the Pharmaceutical Product Identifier (PhPID). Note that you can specify only one type of product identifier. Do not specify a PhPID if you have entered a MPID.
PhPID Version
Enter the version date or number for the Pharmaceutical Product Identifier (PhPID)
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.
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.
Intended Use Name
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.
Name
Enter the Name of the Case Product Registration.
Immediate Report Type
This field determines whether the PMDA E2B (R3) file will be submitted as an immediate report. If the E2B file will be submitted as an immediate report, select an option for the immediate report from the dropdown menu. Select System (E2B) to submit automatically through Vault or select Manual (Fax) to submit the report manually.
Completeness
Select whether the data collection at the time of report submission is complete or incomplete from the dropdown menu.
Report Overview
Enter any additional information on the report. This field is only used for PMDA Research and Safety Measure reports.

PMDA Case Product Registration Fields

Case Product Registration Section
Case Product Registration Section
Field Description
Name
Enter the Name of the Case Product Registration.
Registration Country
Select the Country in which the Case Product is registered.
Product Registration
Select the Product Registration from the dropdown menu. Product registrations are created when you configure the Product.
Rank
To order Case Products by rank, enter the rank number. Products ranked as 1 correspond to the primary product role. If you change a product to rank 1, the system updates the rank of the previous primary product to 2. Ranked records appear in descending order on the Case and in generated ICSR documents.This field does not appear on page layouts by default and must be added by an administrator to appear.

PMDA Local Reporting Details Section

Use the Local Reporting Details section to add PMDA (Japan) region-specific reporting details.

Local Reporting Details
Local Reporting Details
Field Agency Description
Primary Case Product
  • PMDA
Select or search for the primary Case Product.
Primary Case Product Registration
  • PMDA
Select or search for the primary Case Product Registration.
PMDA Reporting Category
  • PMDA
 The reporting category that adverse event belongs to under the PMDA guidelines. This field is available when using Domestic Case Processing and Case Follow-Up (domestic or foreign). The PMDA Reporting Category determines:
  • If the Case is domestic or foreign.
  • If the Case report type is Infection, Adverse Event, Research, or Safety Measure Report.
Select the reporting category from the dropdown menu. The following options are available:
Category Description
AA Post-Marketing Domestic Infection
AB Post-Marketing Domestic AE
AC Post-Marketing Foreign Infection
AD Post-Marketing Foreign AE
AE Post-Marketing Research Infection
AF Post-Marketing Research AE
AG Post-Marketing Safety-Measures
DA Clinical Trial Domestic Infection
DB Clinical Trial Domestic AE
DC Clinical Trial Foreign Infection
DD Clinical Trial Foreign AE
DE Clinical Trial Research Infection
DF Clinical Trial Research AE
DG Clinical Trial Safety-Measures
Completeness
  • PMDA
Select the option that best describes the completeness of the data collection at the time of the PMDA Report.
Immediate Report Type
  • PMDA
Select System (E2B) to classify this report as an Immediate Report in PMDA reporting. When System (E2B) is selected, this field corresponds to code 1 in the PMDA J2.3 E2B data element.
Destination Case ID
  • PMDA
The value entered in the Destination Case ID field on the associated Transmission (Submission or Distribution) record.
Report UID
  • PMDA

The system automatically populates this field.

This identifier is generated using the following logic:

case_number__v.name__v + suffix

The suffix is a two-letter sequence that increments by one letter from the last suffix of the existing Local Reporting Details record. The sequence starts with ‘AA’ and increments by one letter for each subsequent record (for example, AA, AB, AC, AD, and so on). Any unused suffixes in the sequence are used first.

Note The Report UID includes a [suffix] even when a Case only has a single submission.

Substances Section

Use the Substance section to add Substances under a Case Product. Substance records specify the active substance and strength in the product.

By default, this section only appears for External Products and open or single-blinded Study Products.

Add a Substance Record

  1. On the Product record page, expand Substances.
  2. Select Create.
  3. Complete the Create Case Product Substance page.
  4. Select Save.

Case Product Substance Fields

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Substances Section
Field Description
Case Reference to the grandparent Case.
The system automatically populates this field.
Case Product Reference to the parent Case Product.
The system automatically populates this field.
Substance Name
Enter the substance name, as reported.
Strength The substance strength. If the strength is a range, enter the lowest number in the range.
In the first field, enter the number. In the second field, select the unit of measurement.
TermID
Enter the substance Term ID.
TermID Version
Enter the substance Term ID Version or Version Date.

Adverse Events Section

Use the Adverse Events section to add Case Adverse Events with details of each adverse event.

case-adverse-event-section
Case Adverse Events Section

Note Each Case must have a primary Case Adverse Event. As such, you cannot delete a primary Case Adverse Event record. If a primary Case Adverse Event must be deleted, you can designate a different Case Adverse Event as primary using the Rank field, and then delete the non-primary Case Adverse Event.

Add a Case Adverse Event Record

  1. On the Case page, expand the Adverse Events section.
  2. Select Create.
  3. Complete the Create Adverse Event page.
  4. Select Save.

Case Adverse Event Fields

The Case Adverse Event page layout provides fields in the Details and Hospitalization/Treatment sections.

Case Adverse Event Details Section

Adverse Events Details Section
Adverse Events Details Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Primary Indicates the primary adverse event for this report.
Select Yes if the adverse event is the reason for reporting the case or is most likely linked to the suspect product.
Rank

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

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

If you change an adverse event to rank 1, the system updates the rank of the previous primary adverse event to 2. Ranked records appear in ascending order on the Case and in generated ICSR documents.
Seriousness The level of impact the adverse event had on the patient. You can enter multiple values in this field.
Select one or more seriousness criteria to describe the level of impact the adverse event had on the patient. If the event is not serious, do not select a value in this field.
CTCAE Grade The Common Terminology Criteria for Adverse Events (CTCAE) grade for adverse events affecting cancer patients.
For adverse events affecting cancer patients, select the CTCAE grade from the drop-down menu.
Event (Reported) Description of the medical event, as reported by the primary source.

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

The language dropdown menu shows the MedDRA dictionary language being used. English is selected by default.

To learn more, see Code MedDRA Terms.
Event (Reported) - Language The language that the primary source reported the event description in, if other than English.
Use the binoculars icon to search for the language corresponding with the adverse event or enter the language manually.
Event Country
Select the country where the adverse event occurred. Use the binoculars icon to search for the country or start typing for instant search.
Onset The date on which the adverse event or reaction started.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Cessation The date when the adverse event ended.
Use the Calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Duration The overall duration of time that the patient experienced the adverse event.
Auto-Calculation

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

  • Onset
  • Cessation

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

You can also disable auto-calculation for this field to retain the manually entered value. See Manage Auto-Calculation Override for more detail.
Outcome Select the outcome of the adverse event:
  • fatal: Select this option when the patient's death is suspected to be related to the adverse event.
  • not recovered/not resolved/ongoing: Select this option when the patient had not recovered from the adverse event or for an irreversible congenital anomaly.
  • recovered/resolved: Select this option if the patient has fully recuperated from the adverse event.
  • recovered/resolved with sequelae: Select this option for an irreversible medical condition.
  • recovering/resolving: Select this option if the patient is recuperating from the adverse event.
  • unknown: Select this option when the outcome is unknown.
HCP Confirmed Indicates whether a healthcare professional confirmed the adverse event.
The system automatically populates this field for the primary adverse event, based on the Reporter Qualification specified on the initial Inbox Item or AER. Otherwise, you can enter the value manually.
Symptom/Diagnosis Indicates whether the adverse event is a symptom or a diagnosis.
To designate the adverse event as a symptom or a diagnosis, select an option from the list.
Diagnosis To associate an adverse event symptom to a diagnosis, select the Case Diagnosis.
To appear in this list, a medical reviewer must have already entered the Case Diagnosis. The Case Diagnoses section provides instructions.
Watchlist Tags
The system automatically populates this field when a Case Adverse Event matches one or more watchlists configured for the associated Case Product or Study.
To learn more, see How Case Watchlist Tags and DMEs are Assigned.
DME Indicates if the adverse event MedDRA PT matches a Designated Medical Event (DME).
The system automatically populates this field when the adverse event MedDRA PT matches a Designated Medical Event (DME). The suspect product must be registered in the European Union to qualify as a DME.
To learn more, see How Case Watchlist Tags and DMEs are Assigned.

Case Adverse Event Hospitalization/Treatment Section

Case Adverse Event Hospitalization Section
Case Adverse Event Hospitalization/Treatment Section
Field Description
Hospitalization
Select the patient outcome with respect to hospitalization. This is required for FDA VAERS reporting when the Case Adverse Event Seriousness is set to “Caused / Prolonged Hospitalization”.
  • Hospitalization (FDA.E.i.3.2c.1)
  • Prolongation of Hospitalization (FDA.E.i.3.2c.2)
Evaluated/Treated At
Select the type of facility the patient was evaluated or treated at:
  • Doctor/healthcare professional Office (FDA.E.i.3.3a)
  • Emergency Department or urgent care (FDA.E.i.3.3b)
  • Blank (FDA.E.i.3.2g)

This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Hospital Admission Date The date the patient was admitted into the hospital.
Use the calendar pop-up tool or enter the date manually.
Hospital Discharge Date The patient was discharged from the hospital.
Use the calendar pop-up tool or enter the date manually.
Days Hospitalized
Enter the number of days the patient was hospitalized. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Hospital Name
Enter the name of the hospital. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Hospital City
Enter the city where the hospital is located. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Hospital State
Select the state where the hospital is located. This field is used in FDA VAERS reporting.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Diagnoses Section

Use the Diagnoses section to combine signs and symptoms that were reported into a single Case Diagnosis, if required.

Note that by default the Diagnoses section does not appear until the Case is in the Medical Review state.

Add a Case Diagnosis Record

  1. On the Case page, expand the Diagnoses section.
    If the section is not displayed, verify that the Case is in the Medical Review state and that you are assigned the Medical Reviewer user role.
  2. Select Create.
    The Create Case Diagnosis page appears.
  3. Enter the diagnosis, and then select Save.

Result

The diagnosis is added to the Case under Diagnoses.

Case Diagnosis Fields

Case Diagnosis Fields
Diagnoses Details Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Name (MedDRA) The MedDRA term for the case diagnosis.
Enter the term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Name (Reported) Captures a text description of the diagnosis or reclassification of the adverse event.
This field is not currently supported for E2B import or export or any type of report generation.
This field does not appear on page layouts by default and must be added by your Admin.

Assessments Section

The Assessments section displays the assessed relationship between Adverse Events and Suspect or Interacting Products. For any Adverse Event and Product pair, there can be only one (1) Case Assessment. For each Case Assessment, the system generates two (2) Case Assessment Results.

By default, Vault Safety generates Case Assessments for the following pairs:

  • All serious Adverse Events paired with Case Products that have a Drug Role of Suspect or Interacting
  • Primary non-serious Adverse Events paired with primary Case Products that have a Drug Role of Suspect or Interacting

For more information on the ways to generate Assessments, see Generate Assessments.

Add a Case Assessment Record

While the system automatically generates Case Assessments, you may need to add an assessment manually, for example, if you accidentally delete a system-generated assessment.

Note If an E2B-imported Case contains an assessment for an adverse event or suspect product with an unknown link, the system labels the assessment with UNK.

  1. On the Case, expand the Case Assessments section.
  2. Under Case Assessments, select Create.
    The Create Case Assessment page appears.
  3. In the Case Product field, select the suspect product.
  4. In the Case Adverse Event field, select the relevant adverse event.
  5. Enter the assessment details and results.

After You Finish

Enter the Case Assessment Result.

Case Assessment Details Fields

case-assessment
Case Assessment Section

Depending on your Admin’s configuration, some or all of the following fields may appear in your Vault.

Field Description
Case Reference link to the Case.
The system automatically populates this field.
Product Reference link to the Case Product.
The system automatically populates this field with the Case Product this assessment is evaluating.
Event (LLT) Reference link to the Case Adverse Event.
The system automatically populates this field with the Case Adverse Event this assessment is evaluating.
Expected Whether the associated Case Adverse Event is listed on Datasheets associated with the suspect Case Product or associated Study or Study Products.
If your Admin has configured Datasheets, the system populates this field based on the expected reactions listed on the Datasheets. You can select a different option to override the system-calculated value or to enter the value manually. The system uses this value from the primary Case Assessment to populate the Case Expectedness field.
To learn more, see Manage Datasheets and Auto-Expectedness.
Expected (status) How the Expected field was populated, whether system-calculated or with a manual override. By default, users in the Intake and Data Entry roles cannot edit this field.
The system automatically populates this field.
Listed Whether the associated Case Adverse Event is listed on the Datasheet for the Study or Product.
If your Admin has configured Datasheets, the system populates this field based on the expected reactions listed on the Datasheets. You can select a different option to override the system-calculated value or to enter the value manually. The system uses this value from the primary Case Assessment to populate the Case Listedness field.
To learn more, see Manage Datasheets and Auto-Expectedness.
Listed (status) How the Listed field was populated, whether system-calculated or with a manual override. By default, users in the Intake and Data Entry roles cannot edit this field.
The system automatically populates this field.
Reaction Recurrence

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

Note that the option “no – n/a (no rechallenge was done, recurrence is not applicable)” is equivalent to a dechallenge. You can capture the dechallenge details, such as positive or negative, in the case narrative.
First Dose Latency The time interval between the first administered dose of the product and when the adverse event started.
Auto-Calculation

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

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

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

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

To learn more, see How Dose Latency is Calculated.
Last Dose Latency The time interval between the last administered dose of the product and when the adverse event started.
Auto-Calculation

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

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

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

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

To learn more, see How Dose Latency is Calculated.
Rank Ranked assessments are listed in ascending order on the Case.
To order the list of assessments by rank, enter the rank number. The rank of 1 is reserved for the assessment on the primary adverse event and primary product.
Assessment Tag
The system automatically tags Case Assessments as SUSAR or SAE when the appropriate criteria is met:
  • SUSAR: When a Study Case Assessment for a serious, unexpected adverse event paired with a suspect or interacting company product is assessed as related:
    1. The Case Product associated with the Assessment must be
      suspect or interacting
    2. The Case Adverse Event associated with the Assessment must be
      serious
    3. The Expectedness field on the Assessment is set to No or is blank.
    4. The Assessment has at least one Assessment Result with the Causality Established field set to Yes.
  • SAE: When a Case Assessment contains a serious adverse event paired with a suspect or interacting company product:
    1. The Case Product associated with the Assessment must be
      suspect or interacting
    2. The Case Product associated with the Assessment must be selected from the Product Library (i.e. Case Product > Product is selected) or a Study Product.
    3. The Case Adverse Event associated with the Assessment must be
      serious

If neither of the above criteria are met, then the Assessment Tags field is left blank.
Watchlist Tags
If the adverse event and product combination match an entry on a watchlist, select the watchlist.
To learn more, see Configure Adverse Event Watchlists.

Expectedness Section

Vault Safety generates Expectedness records under Case Assessments. Expectedness records identify whether Case Adverse Events (MedDRA terms) are listed on a Product (Core or Local), Study, or Study Product Datasheet.

An Expectedness record is generated for each of the associated Datasheets. Expectedness is evaluated upon case creation and re-evaluated any time the associated Case Adverse Event or Case Product is updated, unless Expectedness has been overridden or manually created.

If the Generate Assessments feature is enabled, Expectedness is also evaluated when Assessments are auto-generated or the Generate Assessments user action is activated. Where Expectedness records don’t exist, the system generates them.

Note On Domestic Cases for Japan, Expectedness records are not generated for Case Products with registrations that are reportable to the PMDA. Instead, Expectedness evaluations appear on Localized Case Assessment records. At the Case-level, Expectedness is set using the most reportable evaluation across all non-PMDA Expectedness records and Localized Case Assessments from the Japan Localized Case. See Most Reportable Case Product and Case Assessment for more information on how this is evaluated.

Depending on your Admin’s configuration, some or all of the following fields may appear in your Vault.

Field Description
Name The name of the Expectedness record.
The system automatically populates this field for system-generated Expectedness.
Datasheet A link to the Datasheet configured in Business Admin.
To view the Datasheet record, select the link.
To learn more, see Manage Datasheets and Auto-Expectedness.
Datasheet Document The associated datasheet document from the Vault Library.
To view the datasheet Vault document, select the link.
Country For Local Datasheets, the country to which the datasheet applies. When evaluating reporting rules, the system uses Local Datasheets within the jurisdiction of the target agency to evaluate the Expectedness rule parameter.
The system automatically populates this field for system-generated Expectedness.
To learn more, see Reporting Rule Parameter Reference.
Expected Indicates whether the Case Adverse Event MedDRA is listed on the referenced Datasheet.
The system automatically populates this field for system-generated Expectedness.
To learn more, see Manage Datasheets and Auto-Expectedness.
Expected (status) How the Expected field was populated, whether system-calculated or with a manual override.
The system automatically populates this field for system-generated Expectedness.

Assessment Results Section

Use the Assessment Results section to enter the assessed relationship between the adverse event and product pair from individual sources.

System-Generated Case Assessment Results

When a Case Assessment is created (either system-generated or user-created), the system generates two child Case Assessment Results as placeholders: one for the company and one for the primary reporter.

The system assigns the Source Type for auto-generated Case Assessment Results using the logic described in the following sections. The Source Type field refers to the Case Assessment Source Controlled Vocabulary.

Clinical Trial Cases

The system generates Case Assessment Results with the following Source Types for a Clinical Trial Case A Case is categorized as a clinical trial case when the Case Report Type is “Study” and the Study Type is “Clinical Trial” or unspecified (blank). :

Case Assessment Result Placeholder Source Type E2B Code1
Company Sponsor 2
Reporter Investigator 1
  1. E2B Code refers to the value in the e2b_code__v field on the Controlled Vocabulary corresponding to the Source Type field.

Postmarket Cases

The system generates Case Assessment Results with the following Source Types for a Spontaneous Case A Case is categorized as a spontaneous case when it has a non-Study Report Type. or Postmarket Study Case A Case is categorized as a postmarket study case when it has a Study Report Type and a Study Type of “Individual Patient Use” or “Other Study”. :

Note For postmarket cases, if the primary Reporter-type Case Contact does not specify the Qualification field, the system-generated Case Assessment Result for the reporter is not assigned a Source Type.

Case Assessment Result Placeholder Qualified HCP?1 Source Type E2B Code2
Company n/a Market Authorization Holder (MAH) 4
Reporter No Non Health Care Professional 6
Reporter Yes Health Care Professional 5
  1. Whether the Qualification selected on the primary Reporter-type Case Contact corresponds to a Qualification Controlled Vocabulary where Qualified HCP=Yes
  2. E2B Code refers to the value in the e2b_code__v field on the Controlled Vocabulary corresponding to the Source Type field.

Enter Case Assessment Results

  1. On the Case, expand Case Assessment Results.
  2. Open the Case Assessment Result that you want to edit, or select Create to add a new Assessment Result.
  3. Complete the fields on the Case Assessment Result page.
  4. Select Save.

Tip You can enter additional comments about the assessment in the Company Comments field in the Case Narrative section.

case-assessment
Case Assessment Results Section

Case Assessment Result Fields

Case Assessment Result Details Fields
Case Assessment Result Details Fields

Depending on your Admin’s configuration, some or all of the following fields may appear in your Vault.

Field Description
Case Reference link to the Case.
The system automatically populates this field.
Case Assessment Reference link to the Case Assessment.
The system automatically populates this field.
Source Type Description of the source of the assessment, such as Sponsor, Investigator, or Health Care Professional.
For auto-generated Case Assessment Results, the system automatically populates the Source Type as follows:
  • Company's Assessment: The Source Type is set to Sponsor or MAH.
  • Reporter's Assessment: The Source Type is set to one of the following, based on the Report Type and the Reporter Qualification specified on the primary Reporter-type Case Contact:
    1. Investigator
    2. Health Care Professional
    3. Non-Health Care Professional
To learn more, see About Generating Assessments.
Source (text)
If you cannot capture the source using an option from the Source Type list, use this field to enter a free text description of the source.
Method of Assessment
Select the option that best describes the method of assessing the case.
Method (text)
If you cannot capture the assessment method using an option from the Method of Assessment list, use this field to enter a free text description of the method.
Assessment Result
Describes the result of the Case Assessment. The system may populate this field or you can select an option.
Assessment Result (Override)
(Optional) An administrator must add this field to the Case page layout.
If you select a value for this field, the system uses this value instead of the Assessment Result value when generating an E2B document or a CIOMS I Transmission or preview. Contact Veeva Support to request this feature be made available in your vault.

Note If you specify an Assessment Result (Override) value, there are two limitations

  • The system will always generate the masked version of aggregate reports.
  • When the system 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 the system maps to Result of Assessment for PMDA E2B(R3).
These limitations will be addressed in a future release.

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

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

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

The system automatically populates this field.
To learn more, see How Case Relatedness is Calculated.

Causes of Death Section

Use the Causes of Death section to enter the details about the reported and autopsy-determined causes of death.

The Causes of Death section appears if at least one of the following conditions are met:

  • The Date of Death field has a value
  • A Case Adverse Event Seriousness field contains "Results in Death"

Add a Cause of Death Record

  1. On the Case, expand Causes of Death.
  2. Select Create.
  3. In the Create Case Cause of Death Type window, select one of the following options:
    • Reported Cause of Death
    • Autopsy-Determined Cause of Death
  4. Select Continue.
  5. Specify the Case Cause of Death fields.
  6. Select Save.

Result

When you save the Cause of Death record, the Causes of Death section is updated with the cause of death and a link to the record.

Cause of Death Fields

Causes of Death Section
Causes of Death Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Cause (Reported) The reported term and MedDRA term for the cause of death.
Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.

Medical History & Concurrent Conditions Section

Use the Medical History & Concurrent Conditions section to add a Medical History record for each event reported in the patient’s medical history.

Add a Medical History Record

  1. On the Case page, under Medical History, select Create.
  2. On the Create Case Medical History page, enter the medical history event details.
  3. Select Save.

Result

When you save the record, the Case Medical History & Concurrent Conditions section is updated with the record and link.

Medical History & Concurrent Conditions Fields

Case Medical History Section
Case Medical History Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Condition/Procedure
Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Start Date Use the calendar pop-up tool to select a date or enter the date manually.
The date when the medical condition started.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Continuing
Select Yes or No to indicate whether the medical condition is currently ongoing.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
End Date The date when the medical condition stopped.
Use the calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Family History
Select Yes or No to indicate whether another family member experienced the same medical condition.
Illness at Vaccination?
Select Yes or No to indicate whether the illness, condition, or symptom was present at or about the time of vaccination.
Comments
Enter any additional relevant information about the medical condition.

Drug History Section

Create a Drug History record for each product reported in the patient’s drug history.

Add a Drug History Record

  1. On the Case page, expand Drug History.
  2. Select Create.
  3. On the Create Case Drug History page, enter the drug history details.
  4. Select Save.

Result

When you save the Drug History record, the case Drug History section is updated with the record and link.

Drug History Fields
Drug History Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Drug Name (Reported)
Enter the name of the product, as reported by the source.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
WHODrug Product code from the WHODrug dictionary.
After entering the reported drug name, select Search WHODrug to automatically populate the search query. Browse and select the appropriate product code using the WHODrug search window.
To learn more, see Code WHODrug Products.
MPID Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Version The WHODrug version for the MPID. This field appears after coding the WHODrug product code.
This field is automatically populated based on the selection from the WHODrug dictionary.
Start Date Use the calendar pop-up tool to select a date or enter the date manually.
The date and time when the product was first administered.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
End Date The date and time when the product was last administered.
Use the calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Indication (LLT) The MedDRA LLT for the drug history product use indication.
Enter the term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Indication (Reported) Captures a text description of the drug history product use indication.
This field is not currently supported for E2B import or export or any type of report generation.
This field does not appear on page layouts by default and must be added by your Admin.
Reaction (LLT) The MedDRA LLT for the reaction to the drug history product.
Enter the term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Reaction (Reported) Captures a text description of the reaction to the drug history product.
This field is not currently supported for E2B import or export or any type of report generation.
This field does not appear on page layouts by default and must be added by your Admin.
Age at Vaccination The age of the patient at the time of vaccination. This field is used in FDA VAERS reporting.
The system recalculates and updates this field any time a field used to calculate this value is updated. If you manually enter a value after the auto-calculation, the system retains the manually entered value. If you manually enter a value and then edit a field used in the auto-calculation, the system will re-calculate and override the manually entered value, assuming there is sufficient data for calculation.

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

Auto-Calculation

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

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

Note Both date fields must be precise to at least the day to be used for auto-calculation.
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.
Trademark Name Part
Enter the trademark or company, if present in the Medicinal 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.
Form Name Part
Enter the pharmaceutical form, if present in the Medicinal Product Name. This field is used in EMA reporting.
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.
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.

Add a Drug History Substance Record

Drug History Substance records capture data for EMA E2B section D.8.r.EU Substance / Specified Substance Identifier and Strength.

Your Admin may need to configure page layouts to enable Case Drug History Substance data entry.

  1. On the Case Drug History page, expand Drug History Substances.
  2. Select Create.
  3. On the Create Case Drug Substance History page, enter the drug history substance details.
  4. Select Save.

Result

When you save the Drug History record, the case Drug History Substances section is updated with the record and link.

Drug History Substance Fields
Drug History Substance Section
Field Description
Case Reference link to the grandparent Case.
The system automatically populates this field.
Case Drug History Reference link to the parent Case Drug History.
The system automatically populates this field.
Strength (Number)
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 Term ID.
TermID Version
Enter the substance Term ID Version or Version Date.

Test Results Section

Create a Case Test Result record for each test result.

Add a Case Test Result Record

  1. On the Case page, expand Lab Test Results.
  2. Select Create.
  3. Complete the Create Case Test Result page.
  4. Select Save.

Result

The Case Test Result is added to the Case.

lab-test-results-section
Lab Test Results Section

Case Test Result Fields

case test result
Test Results Section
Field Description
Case Reference link to the Case.
The system populates this field.
Test Name (Reported) The reported term and MedDRA term for the test performed.
Enter the reported name of the test or procedure in the text field, and then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.
To learn more, see Code MedDRA Terms.
Test Date Date and time (if available) when the test or procedure was performed.
Use the calendar pop-up tool to select a date or enter the date manually.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Test Result
Optionally, enter a Qualifier, such as “Less than” (<). In the Number field, enter the value for the test result. In the Unit field, select the test result unit of measurement from the picklist, or use a custom entry.

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

This field is automatically populated if a custom unit of measurement is entered in the Test Result (Unit) field.
Result (Code) Code to describe the test result.
Select one of the following options from the picklist:
  • Positive
  • Negative
  • Borderline
  • Inconclusive
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 Yes or No to indicate whether the sender has more information about the test result.

Narrative Section

Use the Narrative section on the Case to compose the case narrative and capture additional comments from both the reporter and sender.

When a Case is created, Vault Safety automatically generates a narrative document using the appropriate narrative template.
Narrative Section
Field Description
Case Narrative
The system automatically populates this field with a link to the narrative document, which is generated when you create the Case. To open the narrative document, select the link.
To learn more, see Compose a Case Narrative.
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, this field is prepended with [Blind Protection].
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.
Reporter's Comments
Enter the reporter's comments on the causality assessment, diagnosis, or other relevant topics.

Study Section

When the Case Report Type is set to Study, the Study section appears on the page layout for entering information about the Study the patient is enrolled in.

If a Study was selected on the initial AER or Inbox Item, the study fields are automatically populated with any available Study data configured in Business Admin.

Note You cannot change a Study Arm on a Case once it has been promoted from an AER or Inbox Item.

  • Study Section (Preconfigured Study)
    Study Section (Preconfigured Study)
  • Study Section (Manual Entry)
    Study Section (Manual Entry)
Field Description
Study
Select the Study associated with the report. Once a Study is selected, the study name fields are hidden and the available field values and Registrations from the Study are automatically added to the Case upon saving. Otherwise, you can enter the study information manually.
To learn more, see Manage Studies.
Study Blinded
The system populates this field according to the Blinded setting on the selected Study. This field is read-only.
Study Type The type of study for which the product was administered. Depending on your vault's configuration, this field may only appear when the Report Type is Study.

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

The following options are available by default:

  • Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
  • Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
  • Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.
Study Number (Reported)
Enter the study number for the Study that the Case is associated with.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Study Name
If entering the study information manually, enter the name of the study.
Study Name (Continued)
If entering the study information manually and the study name exceeds the character limit in the Study Name field, you can enter additional characters in this field.
Study Name (reason omitted)
If entering the study information manually and the study name is masked or unavailable, select the reason why the study name is unavailable.
Unblinded By This field appears once the Case is unblinded.
Select the option that best describes who unblinded the Case. By default you can either select Sponsor or Investigator.
Unblinded Reason This field appears once the Case is unblinded.
Enter the reason the Case was unblinded.
Unblinded Date This field appears once the Case is unblinded.
Enter the date when the Case was unblinded.

Study Registrations Section

When the Case Report Type is set to Study, the Study Registrations section appears on the page layout for entering registration information about the Study the patient is enrolled in.

When you select a Study in the Study section and save the page, the system automatically adds each registration configured under the associated Study in Business Admin.

Add a Study Registration Record

  1. On a Case, expand Case Study Registrations.
  2. Select Create.
  3. Complete the Create Case Study Registration page.
  4. Select Save.

Study Registration Fields
Study Registrations Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Registration Number
Manually enter the study registration number as assigned by the reporting country or region. For trials registered in the EU, use this field to enter the EudraCT number.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Registration Country The country where the study is registered.
Select the country from the list or start typing for instant search.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Linked Cases Section

Use the Linked Cases section to link to each related Vault Safety Case.

Add a Case Relationship Record

  1. On the Case page, expand Linked Cases.
  2. Select Create..
  3. Complete the Create Case Relationship page.
  4. Select Save.

Case Relationship Fields

Linked Cases Section
Linked Cases Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Related Case
Select the related Case.
Related Case Identifier
Enter the identification number for the report which is linked to this report.
Retransmit This field controls whether the linked report is included in outbound E2B transmissions for this Case.
To populate the related Case UID in E2B transmissions, select Yes.

Reference Numbers Section

Use the Reference Numbers section to enter Case Identifiers, which contain identification codes for the report from systems outside of Vault Safety.

Add a Case Identifier Record

  1. On the Case page, expand Reference Numbers.
  2. Select Create.
  3. Complete the Create Case Identifier window.
  4. Select Save.

Case Identifier Fields
Reference Numbers Section
Field Description
Case Reference link to the Case.
The system automatically populates this field.
Case Identifier

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

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

  • Capture a case identifier from a legacy system
  • Capture the ID for a report transmitted from another manufacturer who is not the license holder for the suspect product
Source
Enter the name of the organization that associates the report with this identifier.
Type
Select one of the following options:
  • To include the Case Identifier and Source fields on the E2B Transmission document upon E2B export, leave this field blank or select E2B Re-Transmittable.
  • Otherwise, select Non-Transmittable.
Your Admin can configure additional Case Identifier Types.

Documents Section

Use the Documents section to add and manage documents linked to the Case, including the source report, narrative, attachments, literature, and other relevant documents.

Documents Section
Documents Section

For more information on how to add a document to a record, such as a Case, see Add a Document to an Object Record.

E2B Transmission Document Setup

To be included in E2B transmissions, Case documents must be classified with the Case › Source › Attachment or Case › Source › Literature document type. In addition, the document Retransmit field must be set to Yes.

When sending FDA E2B(R2) Transmissions through an AS2 Gateway for Cases with over-the-counter (OTC) drugs, you can also attach OTC carton images. Files must be classified with the Case > Source > Attachment document type and the Attachment Type field must be set to FDA Carton Attachment.

Add a Case Attachment or Literature Document

  1. Go to the Case you want to add a document to.
  2. Expand Documents.
  3. Select Add.
  4. Use one of the following methods to add the document:
    • If the document already exists in the vault library:
      1. Select the document.
      2. Select Close.
    • If you're uploading a new document:
      1. Select Create.
      2. Add the document manually.
  5. Set the document type to either of the following options, as apppropriate:
    • Case › Source › Attachment (C.1.6/A.1.8.1-2)
    • Case › Source › Literature (C.4.r/A.2.2)
  6. Open the document, and complete the document fields.

Case Attachment and Literature Document Fields

In the Document panel, complete the Case attachment and literature document fields in the General and Case sections.

General Fields

Field Description
Name
When you save the document, the system generates a document name using Vault Safety's naming conventions for the associated document type.
Title (Optional) Enter a descriptive name for the document.
Type The document type selected during upload, which should be Case.
Subtype The document subtype selected during upload, which should be Source.
Classification The classification selected during upload, which should be Attachment or Literature.
Version The document version number.
The system populates this field.
Organization (Required) Select the Organization associated with the Case.
Document Link 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 Version Link 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 The Lifecycle Stage the document is in.
The system populates this field.
Lifecycle State Stage ID The Lifecycle State Stage ID the document is in.
The system populates this field.
Case Access Group The Case Access Group inherited from the associated Case. The system populates this field.
This field does not appear on page layouts by default. Depending on your organization’s security configuration, it may be added by your Admin.
Tags The system populates this field with any applicable document tags.

Case Fields

The following document fields appear in either or both of the Attachment and Literature document types.

Field Description
Case Reference link to the Case.
The system populates this field when you add the document to a Case.
Inbox Item Reference link to the source Inbox Item.
The system populates this field when you create an Inbox Item from a document.
Inbound Transmission Reference link to an Inbound Transmission.
The system populates this field if this document was received from an Inbound Transmission.
Retransmit To include the document in E2B transmissions, select Yes.
For EMA E2B submissions, attachment file size cannot exceed 15 MB. All Vault Safety E2B Transmissions have a maximum total size limit of 100 MB.
To learn more, see E2B Document Attachments and Literature References.
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 exceeded the character limit in the Description field, continue the description.
Literature Classification For literature, select the classification. By default, the following options are available:
  • Clinical trial/research
  • Non-clinical trial/research
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 the reason why this information is omitted.
Blind Protection Indicates whether blind protection is enabled for the document.

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

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

Admins can edit Dynamic Access Control (DAC) sharing rules on the document lifecycle to change which user groups have access to blind-protected documents. Vault Help provides more information on modifying DAC.
Product To link this document to a Product, select the associated Product record. The options are filtered by the Organization on the document.
Study To link this document to a Product, select the associated Study record. The options are filtered by the Organization on the document.
Attachment Type For attachments, identifies if the document is an over-the-counter (OTC) carton image.
When sending FDA E2B(R2) Transmissions for a Case with OTC Drugs through an AS2 Gateway, select FDA Carton Attachment.

Remove a Document from a Case

  1. On the Case, expand Documents.
  2. Select the link to open the document you want to remove.
  3. Remove the document using either of the following methods:
    • To keep the document in the library but remove it from the Case:
      1. On the document, select Edit Fields.
      2. In the Case field, remove the linked Case by selecting the "X" icon.
      3. Select Save.
    • To delete the document from the library:
      On the document, from the All Actions (All Actions) menu, select Delete.
      This action deletes the document from your library. Once complete, you are redirected to the Library tab.
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