# 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 <a href="/en/lr/674650/">Create PMDA Post-Market Aggregate Reports</a> 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 <a href="/en/lr/674641/#add-tab">Enable Japan Periodic Reporting - Post-Market Non-Serious (NUPR)</a>.
2. [Update the Aggregate Report object layout][1].
3. [Update the Reporting Family object layout][2].
4. [Upload report templates][3].
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 <a href="/en/lr/674641/#update-perm">Enable Japan Periodic Reporting - Post-Market Non-Serious (NUPR)</a>.

## <a id="update-agg-rep-layout"></a>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:

* [Add the Previous J-PSR Report field][4].
* [Add the Document column][5].
* [Add the Interval Dates section][6].

For information on configuring object layouts, see <a href="/en/lr/26387/">Configuring Object Layouts</a>.

### <a id="add-prev-jpsr"></a>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 <a href="/en/lr/75340/#-how-to-constrain-related-records">Reference Constraint</a> on the **Previous J-PSR Report** field: <br>`object_type__vr.name__v = 'PMDA Post-Market' AND product_family__v = {{this.product_family__v}}`

### <a id="add-doc-col"></a>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**.

### <a id="add-int-date-sec"></a>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 Layou**t 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:** <code>object_type__vr.name__v != 'PMDA Post-Market'</code>
   * **Apply the following display effects:** Hide > Sections > Interval Dates

## <a id="update-rep-fam-layout"></a>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:** <code>object_type__vr.api_name__v = 'product_registration__v'</code>
   * 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**.

## <a id="upload-templates"></a>Upload Report Templates

To use the Japan Post-Marking Serious (J-PSR) aggregate report, download the following
<a href="/en/lr/01178/#standard-table-templates">report table templates</a>:

* J-PSR Line Listing of Adverse Events
* J-PSR Tabulation of Adverse Events

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**.


[1]: #update-agg-rep-layout
[2]: #update-rep-fam-layout
[3]: #upload-templates
[4]: #add-prev-jpsr
[5]: #add-doc-col
[6]: #add-int-date-sec