# Process Pregnancy Cases, Child Information & Parent Information Veeva Safety supports tracking pregnancy information, birth outcomes, and parent history of children who have experienced an adverse event: * **Pregnancy Case**: A standard _Case_ becomes a pregnancy _Case_ when the _Pregnancy Case_ checkbox is selected on either the _Inbox Item_ or _Case_. Specific sections on _Cases_ capture information about pregnancy and birth outcomes. When you first open a pregnancy _Case_, there may be no adverse event to report. In this scenario, the pregnancy _Case_ [tracks the pregnant person's exposure to the product][8], and reporting may be suppressed. If the pregnant person experiences an adverse event, add the data to the existing pregnancy _Case_ and include the _Case_ in reports. * **Child Information**: A _Child Information_ record tracks birth outcomes when there is no adverse event in the child. Vault creates the _Child Information_ within and automatically links it to the applicable pregnancy _Case_. On the pregnancy _Case_, link the _Child Information_ through the _Linked Cases_ section. On _Child Information_ records, enter information about the child, such as gender and weight, along with test results. _Child Information_ fields do not export to safety reports. If a child experiences an adverse event, that must be entered in a separate standard _Case_ and then linked to _Parent Information_. * **Parent Information**: When a child experiences an adverse event, the information about the child is entered in a standard _Case_, which is then linked to _Parent Information_. On _Parent Information_ records, enter information about the parent's medical and drug history, along with concurrent conditions. The following sections highlight pregnancy, child, and parent information processing features and fields included in Safety. For information on standard _Case_ sections, see Case Field Reference. You can also review the provided [example pregnancy and birth outcome scenarios][1] that highlight capturing pregnancy outcomes for children and pregnant parents in an E2B-compliant way. ### Prerequisites To use this feature, your Admin must enable: * Pregnancy Case Intake * Pregnancy and Parent-Child Case Data Collection ## Pregnancy Case Intake This section applies to entering pregnancy information on _Inbox Items_ and marking _Inbox Items_ as pregnancy _Cases_. You can track pregnancy exposure and report adverse events experienced by the mother during case intake. When you promote an _Inbox Item_ to a _Case_, the pregnancy information is copied to the _Case_. ### Marking a Manually Created Inbox Item as a Pregnancy Case To mark an _Inbox Item_ as a pregnancy _Case_: 1. Navigate to the _Inbox Item_. 2. In the _Patients_ section, select the **Pregnancy Case** checkbox. 3. Select **Save**. ### Tracking Pregnancy Exposure to Products {#track-exposure} Add pregnancy _Cases_ to track pregnancy exposure to company products. When there is no adverse event to report, open an _Inbox Item_ or _Case_ for the pregnant patient, using the following settings: * In the applicable field, select **No adverse event (10067482)** to code the MedDRA term: * **Inbox Item**: The **Event** field of the _Events_ section. * **Case**: The **Event (Reported)** field of the _Adverse Events_ section. * In the _Patient_ section, select the **Pregnancy** checkbox. * Leave the _Seriousness_ field blank. * To suppress submissions and exclude the _Case_ from aggregate reports, select **Suppress Submissions**. If the pregnant person experiences an adverse event, you can update the _Case_ with the adverse event and seriousness information.
### Promoting Inbox Items with Pregnancy Information {#promote} When you promote an _Inbox Item_ with pregnancy information to one or more _Cases_, Vault copies the pregnancy field values to the _Case_. Vault also creates a _Child Information_ record that includes a _Test Results_ section. Because _Inbox Items_ do not contain all _Case_ fields and field values, certain pregnancy data may not appear on the _Inbox Item to Case Compare_ page but does merge to the pomoted _Case_. In the _Linked Cases_ section of the main _Case_, Vault links each _Child Information_ record. For each linked _Child Information_ record, Vault sets the _Retransmit_ field to _Yes_. This means that the linked cases are E2B-compliant. For _Inbox Items_ imported using the Vault API, the number of _Child Information_ records Vault creates depends on the number of fetuses reported on the pregnancy _Case_. For example, if the value in the _Number of Fetuses_ field is `2`, Vault creates two _Child Information_ records. If the _Number of Fetuses_ field is blank, Vault creates one record. ## Entering Case Information The following sections are available for entering pregnancy, child, and parent information. ### Pregnancy Information Section {#pregnancy-information-section} On pregnancy _Cases_, enter information about the pregnancy and outcome in the _Pregnancy Information_ section. On _Parent Information_ records that include pregnancy, enter this information in the _Pregnancy Information_ and _Pregnancy Outcomes_ sections. The available _Pregnancy Information_ fields include:
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 Age at Onset 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.
Gestation Age at Outcome For a fetus report, select the gestation period at the outcome of the adverse event. Select the number of complete weeks and days of gestation. For example, selecting ten weeks and six days is a total of 76 days of gestation.
Breastfeeding Select whether breastfeeding occurred at any time before, during, or after the exposure.
Timing of Exposure in Pregnancy Select the applicable timings of exposure in the pregnancy.
Fetal/Infant Status Select the status of the fetus or infant.
Fetal Defect Select the option that best describes whether a fetal defect was reported.
Fetal Outcome Select the option that best describes the fetal outcome.
Congenital Anomaly Select the option that best describes whether a congenital anomaly was reported.
Sponsor Pregnancy Awareness When the sponsor or company was made aware of the pregnancy. Select from the following options:
  • Prospective: The sponsor or company was aware of the pregnancy before the birth.
  • Retrospective: The sponsor or company became aware of the pregnancy after the birth.
Para/Parity Enter the number of completed pregnancies beyond 20 weeks gestation, whether viable or nonviable. Count a multiple gestation pregnancy as a single birth.
Gravida/Gravidity Enter the number of pregnancies the parent has had. Count a multiple gestation pregnancy 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.
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.
Cesarean Type If the Delivery Method is Cesarean section, select the type of cesarean section.
### Child Information Section {#child-information-section} Create a _Child Information_ record to capture details about an infant born from a tracked pregnancy _Case_, when there was no adverse event in the infant. Expand the _Child Information_ section of a _Case_ and select **Create** to enter and save information about the child. Vault automatically links the parent _Case_ and _Child Information_ to each other. For the _Child Information_ section to appear on a _Case_, you must select the **Pregnancy** checkbox in the _Patient_ section of the _Case_. The available _Child Information_ fields include:
Field Description
Organization Select the organization that develops the suspect product or sponsors the study.
Parent Information Vault populates a reference link to the parent 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 Enter 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 when you save the record.
Sex Select the child's sex. Depending on your Admin's configuration, this field may be labeled Gender.
Height Enter 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 Enter 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.
GP MRN Enter 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.
#### Case Test Results Section Once you save a _Child Information_ record, Vault creates _Case Test Result_ records for you to capture the following information: * 1-, 5-, and 10-minute APGAR scores * Birth outcomes * Head circumference If the _Case_ references a MedDRA version, Vault auto-codes the _Test Name_ field on these _Test Results_, with the exception of _Birth Outcome_. Child Test Results Section For more information on _Case Test Results_, see Case Field Reference. ## Entering Birth Outcomes If an adverse event occurs in the fetus or child, it must be captured and reported using a standard _Case_. See [example scenarios][1] below for more information. Capture the adverse event in the child in a standard _Case_ and link the pregnancy _Case_ through the _Linked Cases_ section. For E2B transmissions, you must link the child _Case_ with a _Parent Information_ record. To do so, you must create a _Parent Information_ record. ### Add Parent Information {#add-parent-case} For a parent-child case, use the _Parent Information_ field in the _Patient_ section of the standard _Case_ to capture E2B-compliant parent information using a _Parent Information_ type of _Case_. 1. On the _Case_ with the adverse event in the child, expand the **Patient** section. 2. In the **Parent Information** field, select the **Advanced Search** (Binoculars Icon) 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 information about the parent in the [available fields][3], and then select **Save**. \ Vault saves the parent information and adds a reference in the _Parent Information_ field of the related standard _Case_. 1. To enter the parent's medical history and drug history details on the _Parent Information_ record: 1. On the standard _Case_ page, expand **Patient**. 2. Select the link in the **Parent Information** field to navigate to the _Parent Information_ record. 3. To enter medical history details, expand the **Medical History & Concurrent Conditions** section, select **Create**, and enter details in the [available fields][4]. 4. To enter drug history details, expand the **Parent Drug History** section, select **Create** and enter details in the [available fields][2]. 5. Select **Save**. **Result** Vault transmits _Parent Information_ in section D.10 for E2B(R3) or B.1.10 for E2B(R2). You can return to the _Child Information_ record from the _Children Cases/Information_ section on the _Parent Information_ record. #### Parent Information Fields {#parent-section-fields} Use the _Parent_ section to enter basic parent information, including a name or identifier, age, sex, height, and weight. The available _Parent Information_ fields include:
Field Description
Organization The organization that develops the suspect product or sponsors the study. Vault populates this field with the Organization from the child Case.
Patient Initials / ID 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.
Patient Name Prefix Enter the parent's name prefix or title. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient First Name Enter the parent's first name. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Middle Name Enter the parent's middle name. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Last Name Enter the parent'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 Enter the parent's birth date. Use the Calendar pop-up tool to select a date or enter the date manually. For Vault to export this value to E2B Transmissions, the full date is required with year, month, and day.
Age at Onset Enter the 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 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.

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

You can also disable auto-calculation for this field to retain the manually entered value. For more information, see Manage Auto-Calculation Override.

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

  1. The Date of Birth field on the Parent Information record
  2. The First Admin Date field on the primary Vaccine-type Case Product Dosage

    If there are multiple Dosages under the primary Vaccine-type Case Product, Vault uses the earliest First Admin Date to calculate the age.
Sex Select the parent's sex. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable. Depending on your Admin's configuration, this field may be labeled Gender.
Last Menstrual Period Enter the date when the parent, last experienced a menstrual period. This field is available only if the Sex field is set to Female.
Pregnancy Use this checkbox to identify a case as a pregnancy Case for tracking and capturing pregnancy information. When you select the Pregnancy checkbox, after saving the Parent Information you can enter pregnancy information and outcomes in the available fields.
Pregnant at Exposure Indicates whether the parent was pregnant at the time of vaccination or drug exposure. This field is available only if the Sex field is set to Female. This field is used in FDA VAERS reporting. If the patient was pregnant at the time of exposure, select Yes. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Height Enter 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.
Race Select the parent's race from the picklist. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Ethnicity Select the parent's ethnicity from the picklist. If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Medical History 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 record. Vault 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 record. Vault 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][5] for information on the pregnancy fields available for data entry. #### Pregnancy Outcome See [Pregnancy Information Section][5] for information on the pregnancy fields available for data entry. #### Medical History & Concurrent Conditions Section {#parent-medical-history} Use the _Medical History & Concurrent Conditions_ section on a _Parent Information_ record to enter relevant medical history of the parent.
Field Description
Case Vault populates a reference link to the Parent Information.
Condition/Procedure

Enter the reported term in the text field to code the MedDRA term.
Start Date The date when the medical condition 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.
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 {#parent-drug-history} Use the _Parent Drug History_ section on a _Parent Information_ record to enter the parent's drug history.
Field Description
Case Vault populates a reference link to the Case.
Drug Name (Reported) Enter the name of the product, as reported by the source.
WHODrug The 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.
MPID The Medicinal Product Identifier (MPID) for the product. This field appears after coding the WHODrug product code. Vault populates this field based on the selection from the WHODrug dictionary.
Version The WHODrug version for the MPID. This field appears after coding the WHODrug product code. Vault populates this field based on the selection from the WHODrug dictionary.
Start Date The date and time when the product was first administered. Use the calendar pop-up tool to select a date or enter the date manually.
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.
Indication (LLT) The MedDRA LLT for the product use indication. Enter the term in the text field to code the MedDRA term.
Reaction (LLT) The MedDRA LLT for the reaction to the product. Enter the term in the text field to code the MedDRA term.
Age at Vaccination

The parent's age at the time of vaccination.

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

You can also disable auto-calculation for this field to retain the manually entered value. For more information, see Manage Auto-Calculation Override.

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

  1. The Parent Information 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 Admin must add it to the layout.
## E2B Transmission of Parent-Child Cases For E2B compliant transmission of parent information for parent-child cases, in section D.10 for E2B(R3) or B.1.10 for E2B(R2), you must link the parent and child information using the **Parent Information** field. See E2B Generation Data Mapping for more information. ## Example Pregnancy and Birth Outcome Scenarios {#example-scenarios} The following example scenarios outline how to capture pregnancy outcomes for the mother and child in an E2B-compliant way: * Example 1: No Adverse Event in Mother or Child * Example 2: Adverse Event in Mother, No Adverse Event in Child * Example 3: Adverse Event in Child, No Adverse Event in Mother * Example 4: Adverse Event in Both Mother and Child
### Example 1: No Adverse Event in Mother or Child 1. Update the _Case_ for the tracked pregnancy to add information about the pregnancy outcome. 2. From the _Case_ for the tracked pregnancy, [add _Child Information_][6]. Vault references the tracked pregnancy _Case_ in the _Parent Information_ field on the _Child Information_ record. 3. Add a reference to the _Child Information_ from the _Linked Cases_ section on the _Case_ tracking the pregnancy. Example 1: No Adverse Event in Mother or Child ### Example 2: Adverse Event in Mother, No Adverse Event in Child 1. Update the _Case_ for the tracked pregnancy to add information about the pregnancy outcome and the mother's adverse event. 2. From the _Case_ for the tracked pregnancy, [add _Child Information_][6]. Vault references the tracked pregnancy _Case_ in the _Parent Information_ field on the _Child Information_ record. 3. Add a reference to the _Child Information_ from the _Linked Cases_ section on the _Case_ tracking the pregnancy. Example 2: Adverse Event in Mother, No Adverse Event in Child ### Example 3: Adverse Event in Child, No Adverse Event in Mother 1. Update the _Case_ for the tracked pregnancy to add information about the pregnancy outcome. 2. Open a standard _Case_ to capture the adverse event in the child. 3. From the **Parent Information** field on the _Case_ for the child, [add _Parent Information_][7]. 4. Link the _Case_ for the tracked pregnancy to the child _Case_ using a Linked Case relationship.
Example 3: Adverse Event in Child, No Adverse Event in Mother
### Example 4: Adverse Event in Both Mother and Child 1. Update the _Case_ for the tracked pregnancy to add information about the pregnancy outcome and the mother's adverse event. 2. Open a standard _Case_ (not _Child Information_) to capture the adverse event in the child. 3. From the **Parent Information** field on the _Case_ for the child, [add _Parent Information_][7]. 4. Link the _Case_ for the tracked pregnancy to the child _Case_ using a Linked Case relationship.
Example 4: Adverse Event in Both Mother and Child
[1]: #example-scenarios [2]: #parent-drug-history [3]: #parent-section-fields [4]: #parent-medical-history [5]: #pregnancy-information-section [6]: #child-information-section [7]: #add-parent-case [8]: #track-exposure