Enable Japan Periodic Reporting: Post-Market Serious (J-PSR)

Learn how to configure your Vault for periodic report authoring and table generation for postmarket Serious Cases reportable to the PMDA.

About the Feature

With the 24R2 release, Vault Safety supports Japan Periodic Safety Reports (J-PSRs) for drugs approved for marketing in Japan. When generated, the aggregate report includes postmarket Serious Domestic Cases submitted to the PMDA during a defined period. Vault Safety summarizes the required information in the J-PSR Cumulative Tabulation of Adverse Events Form 3 and J-PSR Line Listing of Adverse Events Form 4 tabulations. This feature also supports tracking reporting interval start and end dates. So, when new reports are generated, they include data from the new and previous reporting intervals, including up to eight (8) years of data. These enhancements help marketing authorization holders (MAHs) collect and submit safety information within drug re-examination periods, meeting PMDA periodic reporting requirements.

After configuring this feature, see Create PMDA Post-Market Aggregate Reports for more information on J-PSRs.

Enablement Overview

Complete the following procedures to enable the Japan Period Reporting: Post-Market Serious (J-PSR) feature in your Vault:

  1. Ensure that PMDA Post-Markets is included on the Aggregate Reports tab. For information on how to add the option, see Add PMDA Post-Markets to the Aggregate Reports Tab in Enable Japan Periodic Reporting - Post-Market Non-Serious (NUPR).
  2. Update the Aggregate Report object layout.
  3. Update the Reporting Family object layout.
  4. Upload report templates.
  5. Ensure that the Aggregate Report Writer permission set is granted Read, Create, Edit, and Delete permissions to PMDA Post-Market. For information on how to update the permission set, see Update Aggregate Report Writer Permissions in Enable Japan Periodic Reporting - Post-Market Non-Serious (NUPR).

Update the Aggregate Report Object Layout

To configure the Aggregate Report layout, go to Admin > Configuration > Objects > Aggregate Report > Layouts > Aggregate Report Detail Page Layout to update the layout as follows:

For information on configuring object layouts, see Configuring Object Layouts.

Add the Previous J-PSR Report Field

Complete the following steps to add the Previous J-PSR Report field to the Details section:

  1. In the Details section, add the Previous J-PSR Report field.
  2. Move the Previous J-PSR Report field to below the Data Period End field.
  3. Select Save.
  4. Configure the following Reference Constraint on the Previous J-PSR Report field:
    object_type__vr.name__v = 'PMDA Post-Market' AND product_family__v = {{this.product_family__v}}

Add the Document Column

Complete the following steps to add the Document column to the Listing of Cases on Interval Report section:

  1. In the Listing of Cases on Interval Report section, select Edit Default Columns.
  2. In the Select Columns to Display dialog, move Document from the Available Columns list to the Selected Columns list.
  3. Move the Document column to below the Case > Name column.
  4. Select Done.

Add the Interval Dates Section

Complete the following steps to add the Interval Dates section:

  1. After the Details section, insert the Aggregate Report Interval related object section with the following configuration:
    • Section Label: “Interval Dates”
    • Creation Option: Prevent Record Creation
  2. In the Interval Dates section, select Edit Default Columns and configure the Selected Columns list to include the following columns in this order:
    • Name
    • Interval Start Date
    • Interval End Date
    • Current Interval
  3. Select Done.
  4. Select Save.
  5. Reselect Aggregate Report Detail Page Layout and create a layout rule with the following configuration:
    • Label: “Hide Interval Dates”
    • Description: “This section is used for the PMDA J-PSR report only.”
    • IF this Layout Rule Expression is TRUE: object_type__vr.name__v != 'PMDA Post-Market'
    • Apply the following display effects: Hide > Sections > Interval Dates

Update the Reporting Family Object Layout

Complete the following steps to add the Product Registrations section to the Reporting Family object layout:

  1. Go to Admin > Configuration > Objects > Reporting Family > Layouts > Reporting Family Detail Page Layout.
  2. After the Studies section, insert the Reporting Family Member related object section with the following configuration:
    • Section Label: “Product Registrations”
    • Creation Option: Create record in pop-up dialog
    • Criteria VQL: object_type__vr.api_name__v = 'product_registration__v'
    • Select the Apply on Create checkbox
  3. In the Product Registrations section, select Edit Default Columns and configure the Selected Columns list to include the following columns in this order:
    • Name
    • Product
    • Product Registration
  4. Select Done.
  5. Select Save.

Upload Report Templates

To use the Japan Post-Marking Serious (J-PSR) aggregate report, download the following templates:

Complete the following steps to upload each template to your Vault:

  1. Go to Business Admin > Templates.
  2. Navigate to Base Document > Template > Aggregate Summary Tabulation > [Template].
  3. Select Create > Document Template.
  4. Enter the following properties for the new document template:
    • Type: Basic Document Template
    • Label: Enter “J-PSR Line Listing of Adverse Events” or “J-PSR Tabulation of Adverse Events” as appropriate.
    • Name: Accept the default system-generated name
    • Status: Active
    • File Details: Select Upload File and select the applicable file.
  5. Select Save.