# Enable Pregnancy and Parent-Child Case Data Collection

Learn how to upgrade your Vault configuration to enable pregnancy and parent-child case data collection.

## About the Feature

Veeva Safety added support to collect information about pregnancy cases and outcomes in 21R1. This page provides instructions to upgrade your Vault configuration to enable this data capture.

For information on using pregnancy _Cases_ for data entry once this feature has been enabled, see <a href="/en/lr/01149/">Process Pregnancy Cases, Child Information & Parent Information</a>.

 <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>:  Vaults originally deployed from the 21R1 Safety template include all of the configuration required for this feature already, with the exception of the following:</p>

<ul>
  <li><a href="#child-info">Permissions to the Child Information Object Type</a></li>
  <li><a href="#post-21r1-case-and-imported-case-object-configuration-changes">Post-21R1: Case and Imported Case Object Configuration Changes</a></li>
  <li><a href="#post-21r1-parent-information-case-configuration-changes">Post-21R1: Parent Information Case Configuration Changes</a></li>
</ul>
    </div>
  </div>
</div>



## Update Case Page Layout

1. Go to **Configuration > Objects**.
2. Open the **Case** (`case_version__v`) object.
3. Go to the **Layouts** tab.
4. Open the **Case Page Layout**.
5. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Pregnancy Case_ field to the _Details_ section.
6. Insert a **Pregnancy Information** section with the following pregnancy fields, which includes moving the _Pregnancy Conception Date_ and _Pregnancy Due Date_ fields out of the _Patient_ section to the _Pregnancy Information_ section:
    * _Pregnancy Conception Date_
    * _Pregnancy Due Date_
    * _Sponsor Pregnancy Awareness_
    * _Para/Parity_
    * _Gravida/Gravidity_
    * _Number of Fetuses_
    * _Pregnancy Outcome_
    * _Date of Pregnancy Outcome_
    * _Delivery Method_
7. Add the following layout rule to hide pregnancy information:
    * **Label**: Enter a Label, such as "Not Pregnancy Case/Pregnant at Exposure"
    * **Status**: Active
    * **IF this Layout Rule Expression is TRUE**: `pregnancy_case__v != true && pregnant_at_vaccination__v != true`
    * **Apply the following display effects**:
      * **Effect:** Hide
      * **Type:** Sections
      * **Values:** Pregnancy Information

## Add Pregnancy-Related Fields to Imported Case

If your Vault receives Imported Cases from an external system that collects pregnancy information, add pregnancy-related to the Imported Case (`imported_case__v`) object type.

### Add Fields to Object Type

1. Go to **Configuration > Objects**.
2. Open the **Case** (`case_version__v`) object.
3. Open the **Object Types** tab.
4. Open the **Actions** menu, and select **Edit Object Type Fields**.
5. Under the **Imported Case** (`imported_case__v`) object type, ensure the following fields are selected:
    * Pregnancy Case
    * Gestation
    * Last Menstrual Date
    * Pregnancy Conception Date
    * Pregnancy Due Date
    * Number of Fetuses
    * Gravida/Gravidity
    * Para/Parity
    * Pregnancy Outcome
    * Delivery Method
    * Date of Pregnancy Outcome
    * Sponsor Pregnancy Awareness
6. Select **Save**.

### Update Imported Case Page Layout

1. Go to **Configuration > Objects**.
2. Open the **Case** (`case_version__v`) object.
3. Go to the **Layouts** tab.
4. Open the **Imported Case Page Layout**.
5. Add the **Pregnancy Case** field to the **Details** section.
6. Insert a **Pregnancy Information** section with the following pregnancy fields, which includes moving the  _Pregnancy Conception Date_ and _Pregnancy Due Date_ fields out of the _Patient_ section to the _Pregnancy Information_ section:
    * _Pregnancy Conception Date_
    * _Pregnancy Due Date_
    * _Sponsor Pregnancy Awareness_
    * _Para/Parity_
    * _Gravida/Gravidity_
    * _Number of Fetuses_
    * _Pregnancy Outcome_
    * _Date of Pregnancy Outcome_
    * _Delivery Method_
7. Add the following layout rule to hide pregnancy information:
    * **Label**: Enter a Label, such as "Not Pregnancy Case/Pregnant at Exposure"
    * **Status**: Active
    * **IF this Layout Rule Expression is TRUE**: `pregnancy_case__v != true && pregnant_at_vaccination__v != true`
    * **Apply the following display effects**:
      * **Effect:** Hide
      * **Type:** Sections
      * **Values:** Pregnancy Information

## Post-21R1: Case and Imported Case Object Configuration Changes

The following configuration changes must be made in all Vaults deployed in 21R1 and earlier.

1. In **Configuration > Objects > Case > Fields**, update the label for the Pregnancy Case (`pregnancy_case__v`) field to "Pregnancy".
2. Go to the **Layouts** tab and complete steps 3-6 on the following layouts:
    * Case Page Layout
    * Imported Case Page Layout
3. (Recommended) Rearrange the following fields on the layout:
    * Move **Last Menstrual Period** below Sex
    * Move **Pregnancy** below Last Menstrual Period
    * Move **Pregnant at Exposure** below Pregnancy
    * Move **Gestation** below Pregnancy Due Date
4. Insert a Related Object section for Child Information Cases:
    * In the **Related Object** field, select the second Case in the list
    * In the **Section Label** field, enter `Child Information`
    * In the **Section Name** field, enter `child_information`
    * In the **Criteria VQL** field, enter: `object_type__vr.api_name__v = 'child_information__v'`
    * Select **Apply on Create**<br>
    6. Include the following columns in the Child Information section:
       * Patient Initials
       * Date of Birth
       * Lifecycle State
5. Change the Menstrual layout rule:
    * Go to the **Layout Rules** tab.
    * Open the **Menstrual** layout rule for editing.
    * Update the **Apply the following display effects** section as follows:
        * For **Controls**, add the following values: Last Menstrual Period, Pregnant at Exposure, Gestation
        * For **Fields**, add the following value: Pregnancy Case
    * Save the layout rule.<br>
6. Change the Not Pregnancy Case/Pregnant at Exposure layout rule:
    * Go to the **Layout Rules** tab.
    * Open the **Not Pregnancy Case/Pregnant at Exposure** layout rule for editing.
    * Update the **Apply the following display effects** section as follows:
        * For **Sections**, add the following values: Pregnancy Information, Child Information
    * Save the layout rule.<br>

## Configure Child Information Case Object Type

Add fields to the object type, and then create a layout for Child Information Cases.

### Add Fields to Object Type

1. Go to **Configuration > Objects**.
2. Open the **Case** (`case_version__v`) object.
3. Open the **Object Types > Fields** tab.
4. Open the **Actions** menu, and select **Edit Object Type Fields**.
5. Under the **Child Information** (`child_information__v`) object type, ensure the following fields are selected:
    * Height
    * Weight
6. Select **Save**.

### Create Child Information Case Layout

1. In **Configuration > Objects > Case**, open the **Layouts** tab.
2. Create a layout for the **Child Information** Object Type.
3. Update the **Details** section to add the following fields:
   * Organization
   * Parent Information
   * Patient Initials / ID
   * Patient Name Prefix
   * Patient First Name
   * Patient Middle Name
   * Patient Last Name
   * Date of Birth
   * Age at Onset
   * Sex
   * Height
   * Weight
   * Hospital MRN
   * GP MRN
4. (Optional) Make the **Organization** field required. The Organization is required to create Child Information and Child Information Test Results with appropriate Sharing Settings. <a href="/en/lr/32857/#how-to-set-up-required-object-type-fields">Setting Up Object Types: How to Set Up Required Object Type Fields</a> provides instructions for setting up required object type fields.
5. For the following fields, update the label as indicated. You can also update the field help text if desired:
    * **Patient Initials / ID:** Child Initials
    * **Patient Prefix:** Child Name Prefix
    * **Patient First Name:** Child First Name
    * **Patient Middle Name:** Child Middle Name
    * **Patient Last Name:** Child Last Name
    * **Age at Onset:** Child Age
6. Insert a **Case Test Results** related object section.

**Result**

The following table shows the _Child Information Case Layout_ after configuration:

<table>
  <col style="width:60%">
  <col style="width:40%">
  <thead>
    <tr>
      <th>Section</th>
      <th>Fields/Columns</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>Child Information</em></td>
      <td>
        <ul>
          <li><em>Organization</em></li>
          <li><em>Parent Information</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child Initials</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child Name Prefix</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child First Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child Middle Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child Last Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Date of Birth</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Child Age</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Gender</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Height</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Weight</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Hospital MRN</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>GP MRN</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Test Results</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Test Name (Reported)</em></li>
          <li><em>Test Name (LLT)</em></li>
          <li><em>Result</em></li>
          <li><em>Result (Code)</em></li>
          <li><em>Result (Text)</em></li>
          <li><em>Test Name (PT)</em></li>
          <li><em>Date</em></li>
          <li><em>Result (Unit)</em></li>
          <li><em>Result (Qualifier)</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Workflow Timeline</em></td>
      <td>
      </td>
    </tr>
    <tr>
      <td><em>Signatures</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Signature Name</em></li>
          <li><em>Signature Meaning</em></li>
          <li><em>Signature Status</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>System Information</em></td>
      <td>
        <ul>
          <li><em>Lifecycle State</em></li>
          <li><em>Created By</em></li>
          <li><em>Last Modified By</em></li>
          <li><em>Case Type</em></li>
          <li><em>Created Date</em></li>
          <li><em>Last Modified Date</em></li>
        </ul>
      </td>
    </tr>
  </tbody>
</table>

## Configure Parent Information Case Object Type

Add study-related fields to the Parent Information (`parental_case__v`) object type. Then, update the Parent Information layout to support entering the related Study on pregnancy cases.

### Add Fields to the Parent Information Object Type

1. Go to **Configuration > Objects**.
2. Open the **Case** (`case_version__v`) object.
3. Open the **Object Types** tab.
4. Open the **Actions** menu, and select **Edit Object Type Fields**.
5. Under the **Parent Information** (`parental_case__v`) object type, select the following fields:
    * _Study Name_
    * _Study Name (Continued)_
    * _Study Name (reason omitted)_
    * _Study Number_
    * _Study Number (reason omitted)_
    * _Study Site_
6. Select **Save**.

### Update the Parental Case Layout

Update the **Parental Case Detail Page Layout** (`parental_case_detail_page_layout__c`) to add fields and add a layout rule.

#### Add Fields to the Layout

1. In **Configuration > Objects > Case**, open the **Layouts** tab.
2. Open the **Parental Case Detail Page Layout** (`parental_case_detail_page_layout__c`).
3. Add the **Pregnancy** field to the **Parent** section.
4. (Optional) Add **Pregnancy Information** and **Pregnancy Outcome** detail sections to organize the pregnancy-related fields.
5. Add the following pregnancy-related fields to the layout:
    * Add the following fields to the **Pregnancy Information** section, if added:
        * Last Menstrual Period
        * Pregnancy Conception Date
        * Pregnancy Due Date
        * Gestation
        * Para/Parity
        * Gravida/Gravidity
        * Number of Fetuses
        * Sponsor pregnancy awareness
    * Add the following fields to the **Pregnancy Outcome** section, if added:
        * Date of Pregnancy Outcome
        * Pregnancy Outcome
        * Delivery Method
6. Ensure the **MedDRA Version** field is on the layout. This field is required to auto-code the Child Test Results.
7. Add the following study-related field controls to the layout. We recommend adding these controls to the **Parent** section:
    * Study
    * Study Site
8. (Optional) Consider moving the **Gestation** field from the **Parent** detail section to the **Pregnancy Information** section. If you move this field to the **Pregnancy Information** section, it may be hidden according to the layout rule described in the following section.
9. For the following fields, update the label as indicated. You can also update the field help text if desired:
    * **Patient Initials / ID:** Parent Initials
    * **Patient Prefix:** Parent Name Prefix
    * **Patient First Name:** Parent First Name
    * **Patient Middle Name:** Parent Middle Name
    * **Patient Last Name:** Parent Last Name
    * **Age at Onset:** Age of Parent
10. (Optional) Rename the **Children Cases** related object section to **Children Cases/Information**.
11. Save the page.

**Result**

The following table shows the _Parental Case Detail Page Layout_ after configuration:

<table>
  <col style="width:60%">
  <col style="width:40%">
  <thead>
    <tr>
      <th>Section</th>
      <th>Fields/Columns</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>Parent</em></td>
      <td>
        <ul>
          <li><em>Organization</em></li>
          <li><em>Pregnancy Case</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Parent Initials</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Parent Name Prefix</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Parent First Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Parent Middle Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Parent Last Name</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Date of Birth</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Age of Parent</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Gender</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Height</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Weight</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Last Menstrual Period</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Pregnant at Exposure</em></li>
          <li><em>Medical History Text</em></li>
          <li><em>Study</em></li>
          <li><em>Study Site</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Pregancy Information</em></td>
      <td>
        <ul>
          <li><em>Pregancy Conception Date</em></li>
          <li><em>Pregancy Due Date</em></li>
          <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Gestation</em></li>
          <li><em>Sponsor Pregancy Awareness</em></li>
          <li><em>Para/Parity</em></li>
          <li><em>Gravida/Gravidity</em></li>
          <li><em>Number of Fetuses</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Pregancy Outcome</em></td>
      <td>
        <ul>
          <li><em>Pregancy Outcome</em></li>
          <li><em>Date of Pregancy Outcome</em></li>
          <li><em>Delivery Method</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Medical History & Concurrent Conditions</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Condition / Procedure (Reported)</em></li>
          <li><em>Condition / Procedure (PT)</em></li>
          <li><em>Continuing</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Parent Drug History</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Drug (Reported)</em></li>
          <li><em>Drug (Coded)</em></li>
          <li><em>Indication (PT)</em></li>
          <li><em>Reaction (PT)</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Children Cases / Information</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Worldwide UID</em></li>
          <li><em>UID</em></li>
          <li><em>Receipt Date</em></li>
          <li><em>New Info Date</em></li>
          <li><em>Due Date</em></li>
          <li><em>Report Type</em></li>
          <li><em>Primary Event Seriousness</em></li>
          <li><em>Expedited</em></li>
          <li><em>Product</em></li>
          <li><em>Primary Event (MedDRA)</em></li>
          <li><em>Event Country</em></li>
          <li><em>Reporter Country</em></li>
          <li><em>Last Modified Date</em></li>
          <li><em>Last Modified By</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Workflow Timeline</em></td>
      <td>
      </td>
    </tr>
    <tr>
      <td><em>Signatures</em></td>
      <td>
        <ul>
          <li><em>Name</em></li>
          <li><em>Signature Name</em></li>
          <li><em>Signature Meaning</em></li>
          <li><em>Signature Status</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>System Information</em></td>
      <td>
        <ul>
          <li><em>Last Modified By</em></li>
          <li><em>Last Modified Date</em></li>
          <li><em>MedDRA Version</em></li>
          <li><em>Name</em></li>
          <li><em>Lifecycle</em></li>
          <li><em>E2B Import</em></li>
          <li><em>Created By</em></li>
          <li><em>Created Date</em></li>
          <li><em>Source MedDRA Version</em></li>
          <li><em>Status</em></li>
          <li><em>Lifecycle State</em></li>
          <li><em>Case Type</em></li>
        </ul>
      </td>
    </tr>
  </tbody>
</table>

#### Add Layout Rules

1. On the **Parental Case Detail Page Layout** (`parental_case_detail_page_layout__c`), go to **Layout Rules**.
2. Add the following layout rule to hide pregnancy-related sections if not tracking pregnancy or if the parent is not pregnant at exposure:
    * **Label**: Enter your preferred Label
    * **Status**: Active
    * **IF this Layout Rule Expression is TRUE**: `pregnancy_case__v != true && pregnant_at_vaccination__v != true`
    * **Apply the following display effects**:
      * **Effect**: Hide
      * **Type**: Sections
      * **Values**: Pregnancy Information, Pregnancy Outcome
3. Add the following rule to hide study-related fields if it is not a pregnancy case:
    * **Label**: Enter your preferred Label
    * **Status**: Active
    * **IF this Layout Rule Expression is TRUE**: `pregnancy_case__v != true`
    * **Apply the following display effects**:
      * **Effect**: Hide
      * **Type**: Fields
      * **Values**: Study, Study Site
4. Update the existing Menstrual (`menstrual__c`) layout rule to hide additional fields if the sex is not female:
    * **Label**: Menstrual
    * **Name**: menstrual__c
    * **Status**: Active
    * **IF this Layout Rule Expression is TRUE:** `gender_value__vr.name__v != "Female"`
    * **Apply the following display effects**:
      * **Effect**: Hide
      * **Type**: Fields
      * **Values**: Last Menstrual (normalized), Last Menstrual, Pregnant at Exposure, Pregnant at Exposure (Reason Omitted), Last Menstrual (reason omitted)

## Post-21R1: Parent Information Case Configuration Changes

We recommend that you make the following configuration changes in all Vaults deployed in 21R1 and earlier.

1. Go to **Configuration > Objects > Case**.
2. Go to the **Layouts** tab, and open the **Parental Case Detail Page Layout**.
3. Rearrange the following fields on the layout:
    * Move **Last Menstrual Period** below Sex
    * Move **Pregnancy** below Last Menstrual Period
    * Move **Pregnant at Exposure** below Pregnancy

## Permissions and Security Updates

Update permission sets as described in the following sections, per your organization's requirements.

### <a id="child-info"></a>Grant Permissions to the Child Information Object Type

For users that require access to the Child Information Case object type, ensure to update permission sets.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Permissions to the Child Information Case object type must be configured in all Vaults created in 21R1 and earlier.</p>
    </div>
  </div>
</div>



1. Go to **Users & Groups > Permission Sets** and open the appropriate permission set, such as Case Entry Actions.
2. Open the **Objects** tab.
3. Select **Case**.
4. On the **Case** permissions page, under **Object Permissions**, grant Read, Create, and Edit permissions to the Child Information object type, as required.

### Grant Permissions to Edit Pregnancy Fields

You must grant users permissions to allow them to read and edit the new pregnancy fields

1. Go to **Users & Groups > Permission Sets** and open the appropriate permission set, such as Case Entry Actions.
2. Open the **Objects** tab.
3. Select **Case**.
4. On the **Case** permissions page, under **Object Field Permissions**, grant Read and Edit permissions to the following fields (as required):
    * Gestation
    * Last Menstrual
    * Pregnancy Conception Date
    * Pregnancy Due Date
    * Pregnancy Case
    * Sponsor Pregnancy Awareness
    * Date of Pregnancy Outcome
    * Pregnancy Outcome
    * Delivery Method
    * Number of Fetuses
    * Para/Parity
    * Gravida/Gravidity

## Additional Resources

Support for collecting pregnancy information on Inbox Items was also added to Safety in 23R1. This feature allows intake users to track pregnancy exposure before Case promotion, facilitating data entry during Case processing.

See <a href="/en/lr/01328/">Enable Pregnancy Case Intake</a> to enable this feature and <a href="/en/lr/01149/#pregnancy-case-intake">Process Pregnancy Cases, Child Information & Parent Information</a> for more information.