# Enable PADER Authoring and Table Generation Learn how to update your Vault's configuration to enable PADER report authoring and table generation. ## About the Feature Support for PADER tabulations was first added in 19R3. Further enhancements were added in 21R1, 22R3, and 23R1. This page provides instructions to upgrade your Vault's configuration to make PADER reports available to users. Once you enable this feature, Create PADER Aggregate Reports describes how to create and generate PADER reports and tabulations. ## Add a PADER Navigation Tab Vaults originally deployed from the 20R2 or later release template will have an inactive PADER navigation tab already. For Vaults deployed in an earlier release, you must add the PADER tab. ### Activate the PADER Tab (For Vaults Deployed in 20R2 or Later) The PADER navigation tab is included by default in the Safety 20R2 template in the _Inactive_ state. You must make this tab active for users to access it. In Admin, go to **Configuration > User Interface > Tabs**, and then under **Aggregate Reports**, change the **Status** of the **PADER** sub-tab to **Active**. ### Add a New PADER Tab (For Vaults Deployed in 20R1 or Earlier) To enable PADER in a Vault originally deployed in 20R1 or earlier, an Admin must add a navigation tab for PADER. In Admin, go to **Configuration > Vault Navigation > Tabs**, and add a PADER sub-tab under **Aggregate Reports**. ## Update User Permissions to Access PADER An Admin must update permission sets for users who need access to view and create PADER reports. Vaults originally deployed after 20R2 may have these permissions already. The permission sets that you need to update depend on your Vault's configuration, but typically you would grant the _Safety Writer_ and _Administration Actions_ permission sets the following access: 1. Add access to the PADER navigation tab for each relevant permission set. 2. Add access to the PADER object type for each relevant permission set. ## New in 23R1: Updated PADER and Appendices Templates In 23R1, PADER templates have been updated for the following report tabulations: * 15 Day and Non-15 Day Summary Reports * Summary of ADR from Postmarketing Sources * Interval Line Listings * Appendix: Non-Primary Suspect Product Report ### Support Enablement Before completing the configuration steps described on this page, Contact Veeva Support to enable this feature in your Vault. In Vaults originally deployed before 23R1, add the new columns supported by these templates as follows: ### Replace PADER 15 Day and Non-15 Day Reports Template 1. Go to **Business Admin > Templates > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select 15 Day and Non-15 Day Summary Reports. 3. Select the 15 Day and Non 15 Day Summary Reports template. 4. On the details page, select **Edit**. 5. Under **More Information**, select **Upload File** and upload the following updated template file: 15 Day and Non 15 Day Summary Reports 6. Select **Save**. ### Replace PADER Summary Tabulation of ADRs from Postmarket Template 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select Summary ADR from Postmarketing Sources. 3. Select the PADER Summary of ADR Tabulation Post market template. 4. On the details page, select **Edit**. 5. Under More Information, select Upload File and upload the following updated template file: PADER Summary of ADR Tabulation Post market 6. Select **Save**. ### Replace PADER Interval Line Listings Template 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select Interval Line Listings of Serious Adverse Reactions. 3. Select the PADER Interval Line Listings Template. 4. On the details page, select **Edit**. 5. Under **More Information**, select **Upload File** and upload the following updated template file: PADER Interval Line Listings Template 6. Select **Save**. ### Replace Appendix: Non-Primary Suspect Product Report Template 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select Non-Primary Suspect Product Report. 3. Select the Non-Primary Suspect Product Report template. 4. On the details page, select **Edit**. 5. Under **More Information**, select **Upload File** and upload the following updated template file: Non-Primary Suspect Product Report 6. Select **Save**. ## New in 21R1: Update Completed State Entry Action for Transmission Lifecycle Starting in 21R1, for PADER reports to run properly, Transmissions must have a Transmission Date. Add the following Entry Action to ensure the Transmission Date is always populated. 1. Go to **Admin > Configuration**. 2. Go to **Object Lifecycles > Transmission Lifecycle**, and then open the **Completed** state. 3. In the **Completed** state, add the following Entry Action: * If **Transmission Date** is blank * **Update Record Field** * Fields: **Transmission Date** * Set to value: `Now()` ## New in 21R1: Updated PADER Report Templates In 21R1, PADER templates have been updated for the following report tabulations: * Summary Tabulation of ADRs from Postmarket * 15 Day and Non-15 Day Summary Reports In Vaults originally deployed before 21R1, Admins must update these templates. ### Replace PADER Summary Tabulation of ADRs from Postmarket Template 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select **Summary ADR from Postmarketing Sources**. 3. Select the **PADER Summary of ADR Tabulation Post market** template. 4. On the **PADER Summary of ADR Tabulation Post market** details page, select **Edit**. 5. Under **More Information**, select **Upload File** and upload the following updated template file: PADER Summary of ADR Tabulation Post market 1. Select **Save**. ### Replace PADER 15 Day and Non-15 Day Reports Template 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select **15 Day and Non-15 Day Summary Reports**. 3. Select the **15 Day and Non 15 Day Summary Reports** template. 4. On the **15 Day and Non 15 Day Summary Reports** details page, select **Edit**. 5. Under **More Information**, select **Upload File** and upload the following updated template file: 15 Day and Non 15 Day Summary Reports 6. Select **Save**. ## New in 21R1: Upload PADER Appendices Report Templates Vault supports the following PADER appendices: * Non-Primary Suspect Product Report * List of Death Cases For Vaults created in 21R1 or later, these appendices are available for PADER reports by default. For Vaults originally deployed in 20R3 or earlier, an Admin must configure the corresponding report templates to make these appendices available. Document Types for the Appendix Non-Primary Suspect Product Report template and Appendix List of Death Cases template will already be available in your Vault. To access them, go to **Configuration**, then **Document Types > Base Document > Template > Aggregate Summary Tabulation**. ### Upload Template: Appendix Non-Primary Suspect Product Report 1. Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select **Create > Document Template**. 3. Specify the following details for the template document: * **Type**: Select **Basic Document Template**. * **Label**: Enter `Non-Primary Suspect Product Report`. * **Name**: This field should be automatically updated. Ensure the name has been updated to `nonprimary_suspect_product_report__c`. The template name must match the Document Type Template name or the report will not generate from the template. * **Status**: Ensure this field is set to **Active**. 4. Under **More Information**, upload the Non-Primary Suspect Product Report template. Download the following file, and then attach it as the template document:
Appendix: Non-Primary Suspect Product Report 5. Select **Save**. **Result** The template for Appendix Non-Primary Suspect Product Report has been added to your Vault. ### Upload Template: Appendix List of Death Cases 1. >Go to **Business Admin > Documents & Binders > Template > Aggregate Summary Tabulation**. 2. Select **Create > Document Template**. 3. Specify the following details for the template document: * **Type**: Select **Basic Document Template**. * **Label**: Enter `List of Death Cases`. * **Name**: This field should be automatically updated. Ensure the name has been updated to `list_of_death_cases__c`. The template name must match the Document Type Template name or the report will not generate from the template. * **Status**: Ensure this field is set to **Active**. 4. Under **More Information**, upload the List of Subjects Who Died During the Reporting Period template. Download the following file, and then attach it as the template document: Appendix: List of Death Cases 5. Select **Save**. **Result** The template for Appendix: List of Death Cases has been added to your Vault. ## Add Documents to Generate Field to Aggregate Report Layout The **Documents to Generate** field must be on the Aggregate Report Detail Page Layout to allow users to generate the Appendix List of Death Cases. The Appendix Non-Primary Suspect Product Report is generated by default for PADER reports generated after 21R1. Go to **Configuration > Objects > Aggregate Report > Layouts > Aggregate Report Detail Page Layout**, and ensure the **Documents to Generate** field is on the layout. If you must add the field, ensure to update the appropriate Permission Sets to grant access to Edit this field. ## Add Local Expedited Field to Submission Layout The **Local Expedited Criteria** (`case_expedited__v`) field is used to generate PADER reports. Ensure this field is displayed on the Submission layout. Go to **Configuration > Objects > Transmission > Layouts > Submission Detail Page Layout**, and ensure the **Local Expedited Criteria** field is on the layout.