Enable Domestic Case Processing

Learn how to update your vault's configuration to enable Domestic Case Processing.

Last Updated Aug 12, 2022

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

Support for Domestic Case Processing was added in 21R3. Vaults created in 22R1 or later include the necessary configuration by default, while vaults originally deployed earlier than 21R3 must have the configuration upgrades described on this page to enable this feature.

Note Before you enable this feature, the Object Lifecycles and Workflow section of the configuration for Localized Submissions and Translation Support must be completed.

Once enabled, Prepare a Domestic Case describes how to use this feature.

Note After enabling this feature, enabling Domestic Case Processing for Agency Jurisdictions is recommended.

Update the User Profile Page Layout

Add the Default Localization field to the User page layout:

1. In the Admin area, go to Configuration > Pages > User Profile Page.
2. Select User Profile Layout.
3. Go to the General Information section.
4. In the Fields picklist, add the Default Localization before the Language field.
5. Save the page.

Configure the Localization Field

1. In Business Admin, go to Organization > Agency (MDFS/NMPA).
2. Select .
3. In the Localization field, Select:
   • Korean (South Korea)” for MFDS

   OR

   • Chinese for NMPA
4. Select Save.

Add the Default Localization Field to the User Records Page Layout

1. In Admin, go to Configuration > Objects > User.
2. On the Page Layouts tab, open the User Detail Page Layout.
3. Select Add from the General Info section.
4. Select Default Localization.
5. Select Save.

Update the Case Object

The following configurations are required on the Case object to enable Domestic Case Processing.

Add the Re-generate a Domestic Case Action to the Case Object

1. In Admin, go to Configuration > Objects > Case > Actions.
2. Select Create.
3. Select Re-generate Domestic Case from the dropdown menu.
4. Select Continue.
5. Select Save.

Re-generate Domestic Case Action

Add the Re-generate a Domestic Case Action to the Case Object Lifecycle

1. In Admin, go to Configuration > Object Lifecycles > Case Lifecycle.
2. Select a State. We recommend configuring the action for the Triage state. However, you can configure the action for any state.
3. Select Edit from the User Actions section of the state page.
4. Select Create Rule.
5. Create the Rule form with the following details:
   • Always
   • Re-generate Domestic Case
   • Action Label: Re-generate Domestic Case
6. Select Save.

Re-generate Domestic Case User Action

Update the Case Page Layout

Add the Default Localization Field

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Case Detail Page Layout.
3. Select Add from the System section.
4. Select Default Localization.
5. Select Save.

(Optional) Create the Hide Default Report Type Layout Rule

1. On the Case Page Layout, select Layout Rules.
2. Select Create.
3. Complete the Create Layout Rule form with the following details:
   • Label: Hide Default Report Type
   • Name: hide_default_report_type_c
   • Hide the Following Page Layout Items:
     • Type: Field
     • Values: Report Type
     • IF this Layout Expression is TRUE: ““Or(Not(IsBlank(localization__vr.name__v)), (localization__vr.name__v='global__v'))”
4. Select Save.

(Optional) Remove the Case Narrative Field from the Narrative Section

1. Navigate to the Narratives section of the Case Details Page Layout.
2. Select beside the Case Narrative field name.
3. Select Save.

Replace Case Fields with App Control Fields

You must replace the following fields with their respective App Control Field versions. App Control fields are denoted by a symbol.

Standard Field vs. App Control Field

To replace a field with its App Control version:

1. Select beside the field name.
2. Select beside the field name.
3. Enter the name or search for the App Control field.
4. Select Done.

Replace the fields in the following table with their app control versions:

Section	App Control to Switch
Patient	Age Group   Age Group
Patient	Medical History Text   Medical History Text
Narratives	Narrative Preview   Narrative Preview
Narratives	Company Comments   Company Comments
Narratives	Reporter's Comments   Reporter's Comments
Study	Study Type   Study Type
Study	Study Name (Reason Omitted)   Study Name (Reason Omitted)
Device Details	Device Follow-Up Type   Device Follow-Up Type
Details	Report Type   Report Type
Details	CIOMS Remarks   CIOMS Remarks

Update the Device Follow-up Type Layout Rule

1. On the Case Page Layout, select Layout Rules.
2. Select Device Follow-up Type.
3. Select .
4. Change the Type to "Controls"
5. Select Save.

Device Follow-up Type Layout Rule

Add the Localization Field to the Child Information Records Page Layout

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Child Information Detail Page Layout.
3. Select Add from the System section.
4. Select Localization.
5. Select Save.

Update the Parental Case Page Layout

Add the Localization Field to the Child Information Records Page Layout

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Parental Information Detail Page Layout.
3. Select Add from the System section.
4. Select Localization.
5. Select Save.

Replace the Medical History Text Field with the App Control Field

1. Navigate to the Parent section of the Parental Case Detail Page Layout.
2. Select beside the Medical History Text field name.
3. Select .
4. Add the Medical History Text app control field.
5. Select Done.

Medical History Text App Control Field

Enable Japanese (PMDA) Domestic Case Processing

The following configurations are required to enable Domestic Case Processing for Japan (PMDA).

Update the Case Page Layout

Add the Case Product Registration Section

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Case Page Layout.
3. Select Related Object from the Add Section drop-down menu.
4. Complete the Related Object form with the following details:
   • Related Object: Case Product Registration
   • Section Label: Case Product Registrations
   • Section Name: case_product_registrations
   • Creation Option: Create record in new page
5. Select Done.

Create the Hide CPR for Non-Japanese Case Page Layout Rule

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Case Page Layout.
3. Select Layout Rules.
4. Select Create.
5. Complete the Create Layout Rule form with the following details:
   • Label: Hide CPR for Non-Japanese Case
   • Name: hide_cpr_for_nonjapanese_case__c
   • Hide the Following Page Layout Items:
     • Type: Sections
     • Values: Case Product Registrations
     • IF this Layout Expression is TRUE: “localization__vr.name__v!=’Japanese(Japan)”
6. Select Save.

Hide CPR for Non-Japanese Case Layout Rule

Update the Case Product Registration Page Layout

Update the Details Section

1. In Admin, go to Configuration > Objects > Case Product Registration.
2. On the Page Layouts tab, open the Case Product Registration Detail Page Layout.
3. Select from the Details section.
4. Add the following fields to the Details section:
   • OTC Drug Channel (App Control)
   • Product (App Control)
   • Dose Form (App Control)
   • Registration Country (App Control)
5. Select Save.
6. Move the Product field to the System section.
7. Select Save.

Add the PMDA Reporting Information Section

1. In Admin, go to Configuration > Objects > Case Product Registration.
2. On the Page Layouts tab, open the Case Product Registration Detail Page Layout.
3. Select Detail Form from the Add Section drop-down menu.
4. Complete the Add Detail form with the following details:
   • Section Label: PMDA Reporting Information
   • Section Name: pmda_reporting_info__c
   • Section Layout: Details Form - Two Columns
5. Select Done.
6. Add the following fields to the PMDA Reporting Information section:
   • PMDA Reporting Category
   • Completeness
   • Immediate Report Type
   • Report Overview
7. Select Save.

PMDA Reporting Information Section

Add the Case Comments Section

1. In Admin, go to Configuration > Objects > Case Product Registration.
2. On the Page Layouts tab, open the Case Product Registration Detail Page Layout.
3. Select Related Object from the Add Section drop-down menu.
4. Complete the Related Object form with the following details:
   • Related Object: Localized Case Comments
   • Section Label: Case Comments
   • Section Name: localized_case_comments__c
   • Creation Option: Create record in new page
5. Select Save.

Case Comments Section

Enable China (NMPA) and Korea (MFDS) Domestic Case Processing

The following configurations are required to enable Domestic Case Processing for China (NMPA) and Korea (MFDS).

Update the Case Page Layout

Add the Regional Section

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Case Page Layout.
3. Select Detail Form from the Add Section drop-down menu.
4. Complete the Add Detail form with the following details:
   • Section Label: Regional
   • Section Name: case_regional_section_control__c
   • Section Layout: Details Form - One Column
5. Select Done.

Create the Hide Regional Section for Global and Japanese Cases Layout Rule

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open the Case Page Layout.
3. Select Layout Rules.
4. Select Create.
5. Complete the Create Layout Rule form with the following details:
   • Label: Hide Regional Section for Global and Japanese Cases
   • Name: hide_regional_section_for_japanese_case__c
   • Hide the Following Page Layout Items:
     • Type: Sections
     • Values: Regional
     • IF this Layout Expression is TRUE: “Or(localization__vr.name__v='Japanese (Japan)', IsBlank(localization__vr.name__v), localization__vr.name__v='Global')”
6. Select Save.

Hide Regional Section for Japanese Case Layout Rule

Update the Case Contact Page Layout

Add the Regional Section

You must add the Regional section to the following Case Contact Page Layouts:

• Health Care Professional Detail Page Layout
• Patient Contact Detail Page Layout
• Reporter Detail Page Layout
• Sender Detail Page Layout
• Facility Detail Page Layout

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open a [Page Layout].
3. Select Detail Form from the Add Section drop-down menu.
4. Complete the Add Detail form with the following details:
   • Section Label: Regional
   • Section Name: case_regional_section_control__c
   • Section Layout: Details Form - One Column
5. Select Done.

Create the Hide Regional Section for Global and Japanese Cases Layout Rule

You must add the layout rule to the following Case Contact Page Layouts:

• Health Care Professional Detail Page Layout
• Patient Contact Detail Page Layout
• Reporter Detail Page Layout
• Sender Detail Page Layout
• Facility Detail Page Layout

1. In Admin, go to Configuration > Objects > Case.
2. On the Page Layouts tab, open a [Page Layout].
3. Select Layout Rules.
4. Select Create.
5. Complete the Create Layout Rule form with the following details:
   • Label: Hide Regional Section for Global and Japanese Cases
   • Name: hide_regional_section_for_japanese_case__c
   • Hide the Following Page Layout Items:
     • Type: Sections
     • Values: Regional
     • IF this Layout Expression is TRUE: “Or(localization__vr.name__v='Japanese (Japan)', IsBlank(localization__vr.name__v), localization__vr.name__v='Global')”
6. Select Save.

Hide Regional Section for Japanese Case Layout Rule

Replace Case Contact Fields with App Control Fields

You must replace the following fields with their respective App Control Field versions. App Control fields are denoted by a symbol.

Standard Field vs. App Control Field

To replace a field with its App Control version:

1. Select beside the field name.
2. Select beside the field name.
3. Enter the name or search for the App Control field.
4. Select Done.

Replace the fields in the follwing table with their app control versions:

Page Layout	Section	App Control to Switch
Case Contact (All)	Reporter Health Care Professional Patient Contact Facility	Address: Street Line 2   Address: Street Line 2
Case Contact (All)	Reporter Health Care Professional	Qualification   Qualification
Case Contact (All)	Sender	Organization   Organization
Case Contact (All)	Facility	Facility Name   Facility Name Facility Type   Facility Type
Case Contact (All)	Sender	Department   Department Sender Type   Sender Type Address: Street   Street City   City State/Province   State/Province Country   Country

Update the Case Product Page Layout

Update the Combination Product Layout Rule

You must update the Combination Product layout rule to the following Case Product Page Layouts:

• Biologic Page Layout
• Drug Page Layout
• Device Page Layout
• Vaccine Page Layout

1. In Admin, go to Configuration > Objects > Case Product.
2. On the Page Layouts tab, open a [Page Layout].
3. Select Layout Rules.
4. Select Combination Product.
5. Add the following to the Hide the Following Page Layout Items section:
   • Type: Controls
   • Values: Combination Product
6. Select Save.

Combination Product Value Hidden

Update the Blinded Rule Layout Rule

1. In Admin, go to Configuration > Objects > Case Product.
2. On the Page Layouts tab, open a Study Product Page Layout.
3. Select Layout Rules.
4. Select Blinded Rule.
5. Add the following to the Hide the Following Page Layout Items section:
   • Type: Controls
   • Values: Product (Reported)
   • IF this Layout Rule Expression is TRUE: If(IsBlank(blinded__v), if(IsBlank(case_blinded__v), if(IsBlank(study_blinded__v), FALSE, study_blinded__v), case_blinded__v), blinded__v)
6. Select Save.

Replace Case Product Fields with App Control Fields

You must replace the following fields with their respective App Control Field versions. App Control fields are denoted by a symbol.

Standard Field vs. App Control Field

To replace a field with its App Control version:

1. Select beside the field name.
2. Select beside the field name.
3. Enter the name or search for the App Control field.
4. Select Done.

Replace the fields in the follwing table with their app control versions:

Page Layout	Section	App Control to Switch
Case Product (All)	Details	Drug Role   Drug Role Product (Reported)   Product (Reported) Country Obtained   Country Obtained Action Taken   Action Taken Combination Product   Combination Product
Case Product > Device Details Page Layout	Details	Other Additional Information   Other Additional Information
Case Product > Device Details Page Layout	Device Information	Device Usage Type   Device Usage Type
Case Product > Device Details Page Layout	Registration	Compounding Type   Compounding Type Product (Coded)   Product (Coded) Registration Country   Registration Country Combination Type   Combination Type
Case Product > External Product Page Layout	Other Additional Information	Other Additional Information   Other Additional Information
Case Product > Vaccine Page Layout	Registrations	Compounding Type   Compounding Type Combination Type   Combination Type
Case Product > Study Product Page Layout	Details	Other Additional Information   Other Additional Information
Case Product > Study Product Page Layout	Registrations	Compounding Type   Compounding Type Combination Type   Combination Type

Replace Case Product Fields with App Control Fields

You must replace the following fields with their respective App Control Field versions. App Control fields are denoted by a symbol.

Standard Field vs. App Control Field

To replace a field with its App Control version:

1. Select beside the field name.
2. Select beside the field name.
3. Enter the name or search for the App Control field.
4. Select Done.

Replace the fields in the follwing table with their app control versions:

Page Layout	Section	App Control to Switch
Case Adverse Event	Details	Event Country   Event Country Outcome   Outcome Highlighted Term   Highlighted Term
Case Assessments > Case Assessment Result	Details	Source Type   Source Type Method of Assessment   Method of Assessment Assessment Result   Assessment Result
Case Medical History	Details	Comments   Comments
Case Test Results	Details	Result (Text)   Result (Text) Result (Code)   Result (Code) Comments   Comments

Security

(Optional) Configure Read Permission for the Localization Field

We recommend you set Read permissions on the Localization field of the Case object for all Permission Sets except Vault Owner.

1. In Business Admin, go to Users & Groups > Permission Sets > [Permission Set] > Objects > Case > Object Field Permissions > Localization.
2. Select Edit.
3. Set the Read permission for this field for all roles except Vault Owner.
4. Select Save.

Configure Edit Permission for the Session Store ID Field

You must set Edit permissions on the Session Store ID field of the Case object for the following Vault Permission sets:

• Case Distribution
• Case Entry
• Case Intake
• Case Review
• Case Translation

1. In Business Admin, go to Users & Groups > Permission Sets > [Permission Set] > Objects > Case > Object Field Permissions > Session Store ID.
2. Select Edit.
3. Set the Edit permission for this field.
4. Select Save.

Add Read and Edit Permissions to All Localized Objects on the Case Entry Permission Set

1. In Business Admin, go to Users & Groups > Permission Sets > Case Entry Actions > Objects.
2. Select Edit.
3. Add Read and Edit permissions to all Localized Case objects:
   • Localized Case
   • Localized Case Adverse Event
   • Localized Case Assessment
   • Localized Case Assessment Result
   • Localized Case Cause of Death
   • Localized Case Comment
   • Localized Case Contact
   • Localized Case Document
   • Localized Case Drug History
   • Localized Case Identifier
   • Localized Case Medical History
   • Localized Case Product
   • Localized Case Product Dosage
   • Localized Case Product Indication
   • Localized Case Product Substance
   • Localized Case Test Result
   • Localized Controlled Vocabulary
   • Localized Country
   • Localized Dose Form
   • Localized Organization
   • Localized Product
   • Localized Reason Omitted
   • Localized Route of Administration
   • Localized Study
   • Localized Study Arm
   • Localized Substance
   • Localized Unit of Measurement
4. Select Save.

Add Read Permissions to All Localized Objects on Case Permission Sets

You must Read permissions to the following Case Permission Sets:

• Case Distribution
• Case Intake
• Case Review
• Case Translation

1. In Business Admin, go to Users & Groups > Permission Sets > [Permission Set] > Objects.
2. Select Edit.
3. Add Read permissions to all Localized Case objects:
   • Localized Case
   • Localized Case Adverse Event
   • Localized Case Assessment
   • Localized Case Assessment Result
   • Localized Case Cause of Death
   • Localized Case Comment
   • Localized Case Contact
   • Localized Case Document
   • Localized Case Drug History
   • Localized Case Identifier
   • Localized Case Medical History
   • Localized Case Product
   • Localized Case Product Dosage
   • Localized Case Product Indication
   • Localized Case Product Substance
   • Localized Case Test Result
   • Localized Controlled Vocabulary
   • Localized Country
   • Localized Dose Form
   • Localized Organization
   • Localized Product
   • Localized Reason Omitted
   • Localized Route of Administration
   • Localized Study
   • Localized Study Arm
   • Localized Substance
   • Localized Unit of Measurement
4. Select Save.

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