Enable PMDA Multi-Submission with Localized Case

Learn how to configure your Vault to support PMDA Multi-Submission with Localized Case.

Last Updated Apr 27, 2023

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 submitting multiple PMDA Submissions from a single Case was added to Vault Safety in 23R1. Vaults created in 23R1 or later include the necessary configuration by default, while Vaults originally deployed earlier than 23R1 must have the configuration upgrades described on this page to enable this feature.

Note If your Vault was provisioned prior to 21R1, you will need to enable the Local Fields for PMDA (Japan) feature.

23R1 Update: Enhancements for Current Case Product Registration

The following configuration steps are general enhancements for Case Product Registration. To configure the PMDA Multi-Submissions with Localized Case feature, see Configure PMDA Multi-Submission with Localized Case below.

Update Field Defaults and Object Type for Case Product Registration

1. Go to Admin > Configuration > Objects > Case Product Registration.
2. In the Details tab, set the Default Object Type to “Japan”.
3. In the Object Types tab, select Base Case Product Registration, and set its Status to “Inactive”.
4. In the Fields tab, change the following field settings as shown in the table below:

Field	Setting	Value
Case	Default Value	localized_case__vr.case__v
Case Product	Criteria VQL	case_version__v = {{this.case__v}}

Update Field Defaults for Localized Case Comment

1. Go to Admin > Configuration > Objects > Localized Case Comment > Fields.
2. For the Case field, set the Default Value to “Localized Case > Case” (localized_case__vr.case__v)

Update Create Options for Page Layouts

1. Go to Admin > Configuration > Objects .
2. For each of the following Object Page Layouts, click the Edit () icon of the listed section.
3. In the Edit Related Object Section window, set the Creation Option to “Create record in pop-up dialog”.

Object	Page Layout	Section
Case	Case Page Layout	Case Product Registrations
Localized Case	Localized Case Detail Page Layout	Product Registrations
Localized Case	Localized Case Detail Page Layout	Case Comments

Configure PMDA Multi-Submission with Localized Case

To configure the PMDA Multi-Submission with Localized Case feature in your Vault, complete the steps described in the following sections.

Update the Field Labels for Deprecated Fields

Go to Admin > Configuration > Objects > Case Product Registration.

Update the field labels listed below to add “(NOT USED)” to their label:

Field	Label	Display in default list and hovercards
completeness__v	Completeness (NOT USED)
immediate_report_type__v	Immediate Report Type (NOT USED)
pmda_reporting_category__v	PMDA Reporting Category (NOT USED)	Clear checkbox
report_overview__v	Report Overview (NOT USED)
registration_type__v	Registration Type (NOT USED)

Go to Admin > Configuration > Objects > Localized Case Comment.

Update the field labels as listed below to add “(NOT USED)” to their label:

Field	Label	Display in default list and hovercards
case_product__v	Case Product (NOT USED)
case_product_registration__v	Case Product Registration (NOT USED)	Clear checkbox

Set the Localized Case Default Value

Go to Admin > Configuration > Objects > Local Reporting Details > Fields > Localized Case.

Set the Default Value to primary_case_product_registration__vr.localized_case__v.

Set the Criteria VQL to case_version__v = {{this.case__v}}.

Page Layout Updates

Go to Admin > Configuration > Objects.

Use the table below to update the respective page layouts:

Object	Page Layout
Case Product Registration	Japan Detail Page Layout
Localized Case Comment	Case Comments Detail Page Layout
Local Reporting Details	Local Reporting Details Detail Page Layout
Local Reporting Details/Product Join	Local Reporting Details/Product Join Detail Page Layout
Case	Case Page Layout
Localized Case	Localized Case Detail Page Layout

Japan Detail Page Layout

1. Replace the Registration Type (NOT USED) field with the Registration Type field.
2. Remove the Reporting Information section.
3. Remove the Case Comments section.

Case Comments Detail Page Layout

1. Remove the Case Product (NOT USED) and Case Product Registration (NOT USED) fields.
2. Add the Local Reporting Details and Primary Product Registration fields.

Case Comments Detail Page Layout

Local Reporting Details Detail Page Layout

1. Add the System section.

   

   Edit Detail Section

2. Move the system-related fields to the System section.
   

   

   System Section Fields

   Add the Local Reporting Details/Product Join Related Object section as shown below:

   

   Add Related Object: Local Reporting Details/Product Join

   

   PMDA Reportable Products

3. Add the Case Comments Related Object section as shown below.

   

   Add Related Object: Localized Case Comments

   

   Localized Case Comments

4. Edit the Details section as shown below.

   

   Edit Details Section

   

   Details Section Fields

Local Reporting Details/Product Join Detail Page Layout

1. Add the System section.

   

   Add System Section

2. Move the following fields to the System section:

   

   System Section Fields

3. Edit the Details section as shown below:

   

   Details Section Fields

Case Page Layout

1. Edit the Case Product Registrations section:
   1. Remove the PMDA Reporting Category (NOT USED) field.
   2. Add the Registration Category and Registration Type fields.
2. Add the Local Reporting Details Related Object section as shown below:

   

   Add Related Object: Local Reporting Details

   

   Local Reporting Details

3. Save the Page Layout.
4. Go to Layout Rules.
5. Select the Hide PMDA Regional for non-Japanese case Layout Rule.
6. In the Hide the following Page Layout Items section, add the Local Reporting Details section as shown below:

   

   Hide Local Reporting Details

Localized Case Detail Page Layout

1. Edit the columns in the Product Registrations section:
   1. Remove the PMDA Reporting Category (NOT USED) field.
   2. Add the Registration Category and Registration Type field.

      

      Product Registrations

2. Add the Local Reporting Details Related Object section as shown below:

   

   Add Related Object: Local Reporting Details

   

   Local Reporting Details

Localized Case Page Layout

1. Edit the Case Product Registrations section:
   1. Remove the PMDA Reporting Category (NOT USED) field.
   2. Add the Registration Categorystrong> and Registration Type fields.

      

      Product Registrations

2. Add the Local Reporting Details Related Object section and move it after the Product Registrations section.

   

   Local Reporting Details

3. Edit the Submission section to add Local Reporting Details to the list of displayed columns:

   

   Submissions & Distributions

4. Edit the Case Comments section:
   1. Remove the Case Product Registration (NOT USED) field.
   2. Add the Local Reporting Details field.

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