Enable PMDA Multi-Submission with Localized Case

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

About the Feature

Support for submitting multiple PMDA Submissions from a single Case was added to Veeva 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.

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. Navigate 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. Navigate 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 Layouts

1. Navigate to Admin > Configuration > Objects.
2. For each of the following 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	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

1. Navigate to Admin > Configuration > Objects > Case Product Registration.
2. 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)

1. Navigate to Admin > Configuration > Objects > Localized Case Comment.
2. 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

1. Navigate to Admin > Configuration > Objects > Local Reporting Details > Fields > Localized Case.
2. Set the Default Value to primary_case_product_registration__vr.localized_case__v.
3. Set the Criteria VQL to case_version__v = {{this.case__v}}.

Layout Updates

Navigate to Admin > Configuration > Objects, then use the table below to update the respective layouts:

Object	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.

Local Reporting Details Detail Page Layout

Configure the layout with the following sections and fields/columns:

Section	Settings	Fields/Columns
Details	Type: Detail Form Section Label: Details Section Name: details__c Section Layout: Detail Form - One Column	Case Localized Case Primary Case Product Primary Case Product Registration PMDA Reporting Category Completeness Immediate Report Type Destination Case ID Report UID
Case Comments	Type: Related Object Related Object: Localized Case Comment Section Label: Localized Case Comments Section Name: localized_case_comments__c Creation Option: Create record in pop-up dialog	Name Comments Label Comments Text Local Reporting Details Primary Product Registration
Local Reporting Details	Type: Related Object Related Object: Local Reporting Details/Product Join Section Label: PMDA Reportbale Products Section Name: local_reporting_detailsproduct_joins__c Creation Option: Create record in pop-up dialog	Name Case Product Case Product Registration Rank Drug Role
System	Type: Detail Form Section Label: System Section Name: system__c Section Layout: Detail Form - Two Columns	Created Date Created By Last Modified Date Last Modified By Status Organization Name

Local Reporting Details/Product Join Detail Page Layout

1. Insert the System section with the following settings:
   • Section Type: Detail Form
   • Section Label: Case Summary
   • Section Layout: Detail Form - Two Columns
2. Move the following fields to the System section:
   • Created By
   • Created Date
   • Last Modified By
   • Last Modified Date
   • Status
   • Case
   • Localized Case
   • Organization
   • Name
3. Edit the Details section fields as follows:
   • Case
   • Localized Case
   • Case Product
   • Case Product Registration
   • Drug Role
   • Local Reporting Details
   • Rank
   • Registration Category

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. Insert the Local Reporting Details Related Object section.
3. Save the page.
4. Navigate to Layout Rules.
5. Select the Hide PMDA Regional for non-Japanese case Layout Rule.
6. Update the Apply the following display effects section as follows:
   • Effect: Hide
   • Type: Sections
   • Values: Case Product Registrations, 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.
2. Insert the Local Reporting Details Related Object section and move it after the Product Registrations section.
3. Edit the Submission section to add Local Reporting Details to the list of displayed columns.
4. Edit the Case Comments section:
   1. Remove the Case Product Registration (NOT USED) field.
   2. Add the Local Reporting Details field.