# Configure Workbench PADER Aggregate Reports

Learn how to set up PADER aggregate reports in Safety Workbench.

Safety Workbench provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.

This page describes the different [PADER views][1] and their data when generated by a user, as well as how to set up [_Aggregate Reporting Groups_][2] and their respective _Product Registrations_ and _Study Registrations_. For more information about how to create Workbench PADERs, see <a href="/en/gr/774124/">Create Workbench PADER Aggregate Reports</a>.

## About Provisioned PADER Views

Safety Workbench includes some preconfigured PADER views that you can provision for your Vault. If you would like these views added to your Vault, contact your Veeva Representative.

The following table describes the available PADER views:

<table>
    <thead>
          <tr>
               <td><strong>View Type</strong></td>
               <td><strong>View Name</strong></td>
               <td><strong>Description</strong></td>
          </tr>
    </thead>
    <tbody>
          <tr>
               <td><em>Principal View</em></td>
               <td><em>PADER Principal View</em></td>
               <td>Returns all <em>Case</em> versions that qualify for the PADER, including nullified and voided <em>Cases</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version</em></td>
               <td>Returns a list of the latest <em>Case</em> versions from the <em>PADER Principal View</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > 15 Day Non-15 Day Tabulation</em></td>
               <td>Returns <em>Adverse Event</em> counts grouped by <em>Report Type</em> and categorized by initial <em>Case</em>, follow-up <em>Case</em>, <em>Seriousness</em>, and <em>Labeledness</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > 15-Day Report Line Listing Summary</em></td>
               <td>Summary counts of 15 day <em>Cases</em> and <em>Submissions</em> broken down by initial/follow-up.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Case Series</em></td>
               <td><em>Case</em> listing of all <em>Cases</em> on the PADER in a flattened Excel format.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Cases under other NDA's</em></td>
               <td>A line listing report that returns <em>Cases</em> that were submitted to the FDA under a registration other than that in the <em>Aggregate Reporting Group</em><sup><a href="#cases-under-another-nda-footnote">1</a></sup>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > List of Death Cases</em></td>
               <td>Case listing of Death <em>Cases</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > List of Nullified Cases</em></td>
               <td>Case listing of Nullified cases during the reporting interval.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Malfunction Line Listing</em></td>
               <td>A line listing report for <em>Cases</em> that include combination products with a device constituent that has malfunctioned. Returns a list of device malfunctions categorized by the FDA report type, initial <em>Case</em>, follow-up <em>Case</em>, <em>Seriousness</em>, <em>Listedness</em>, and expedited reporting.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Malfunction Tabulation</em></td>
               <td>A tabulation report for <em>Cases</em> that include combination products with a device constituent that has malfunctioned. Returns the <em>Adverse Event</em> counts grouped by SOC and PT MedDRA levels and categorized by <em>Seriousness</em> and <em>Listedness</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Non-Expedited Line Listing Summary</em></td>
               <td>Summary counts of non-expedited <em>Cases</em> and <em>Submissions</em> broken down by Initial/Follow-up.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Summary for Combination Products</em></td>
               <td>A summary report for <em>Cases</em> that include combination products with a device constituent that has malfunctioned. Returns a count of <em>Case</em> versions and submissions categorized by initial and follow-up <em>Case</em>.</td>
          </tr>
          <tr>
               <td><em>Workbench View</em></td>
               <td><em>PADER Principal > Latest Version > Summary Tabulation of ADR's</em></td>
               <td>Returns the <em>Adverse Event</em> counts grouped by SOC and PT MedDRA levels and categorized by domestic <em>Cases</em>, foreign <em>Cases</em>, <em>Seriousness</em>, and <em>Labeledness</em>.</td>
          </tr>
    </tbody>
    <tfoot>
      <tr>
         <td colspan="3">
            <a id="cases-under-another-nda-footnote"></a>1. To identify <em>Cases</em> submitted under another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA), Vault looks at whether the <em>Reportable Product Registration</em> on the <em>Transmission</em> matches a <a href="#product-registrations"><em>Product Registration</em></a> on the respective <em>Aggregate Reporting Group</em>. If a match does not exist, Vault includes the <em>Case</em> in the <a href="/en/gr/774124/#cases-under-other-ndas"><em>Cases Submitted under other NDA's</em></a> report.
            <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If the <em>Reportable Product Registration</em> and <em>Reportable Product</em> fields are not on the <em>Transmission</em>, your Admin must <a href="/en/gr/26387/#how-to-add-object-fields">add these fields to the layout</a>.</p>
    </div>
  </div>
</div>

</td>
      </tr>
    </tfoot>
</table>

## Configure Aggregate Reporting Groups

_Aggregate Reporting Groups_ define which _Product Registrations_ and _Study Registrations_ to include on the Workbench aggregate report. Once you configure the _Aggregate Reporting Group_, it will synchronize with Safety Workbench in the daily <a href="/en/gr/752926/#recurring-data-extraction-from-vault-safety">data refresh</a>.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: There is a limitation for creating <em>Aggregate Reporting Groups</em> for PADERs with <em>Combination Products</em>. If the <em>Aggregate Reporting Group</em> includes a registration for a <em>Combination Product</em> and a non-<em>Combination Product</em>, Vault ignores the non-<em>Combination Product</em> registration when generating a PADER.</p>
    </div>
  </div>
</div>



To create _Aggregate Reporting Groups_:
1. Navigate to **Business Admin > Objects > Aggregate Reporting Groups**.
2. Select **Create**.
3. Complete the following information:
    * **Name**: Enter a name for the _Aggregate Reporting Group_.
    * **Aggregate Report Type**: From the drop-down, select the aggregate report types this group applies to.
4. Select **Save** or **Save + Create** to save this group and create another.

On the newly created _Aggregate Reporting Group_, expand the sections below to add records.

### Product Registrations

To add _Product Registrations_:
1. Select **Add**.
2. In the _Search: Product Registration_ window, use the search bar or filters to refine your search.
3. Select from the existing list or create <a href="/en/gr/01215/#add-product-registration-details">_Product Registrations_</a> as needed.
4. Select **OK**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: When selecting <em>Product Registrations</em> for PADER reports, Vault includes all <em>Product Registrations</em> with the same <em>Registration Number</em> in the resulting PADER. If your <em>Product Library</em> has multiple <em>Products</em> with the same <em>Registration Number</em>, you need add only one of those <em>Products</em> to this section.</p>
    </div>
  </div>
</div>



### Study Registrations

To add _Study Registrations_:
1. Select **Add**.
2. In the _Search: Product Registration_ window, use the search bar or filters to refine your search.
3. Select from the existing list or create <a href="/en/gr/01216/#add-a-study-registration">_Study Registrations_</a> as needed.
4. Select **OK**.

### Aggregate Reports

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: The <em>Aggregate Reports</em> section on the <em>Aggregate Reporting Group</em> record applies to Workbench aggregate reports only.</p>
    </div>
  </div>
</div>



To add a Workbench PADER to an _Aggregate Reporting Group_:
1. Navigate to the **Workbench > Ad Hoc Reports** tab.
2. Select a <a href="/en/gr/774124/#create-a-workbench-pader">PADER</a> and select **Edit**.
3. Do one of the following:
    * Expand the _Filters_ section and populate the _Aggregate Reporting Group Name_ filter value.
    * Create the _Aggregate Reporting Group Name_ filter if it does not yet exist: **(filter) _Aggregate Reporting Group Name_ (operator) _equals_ (value) [_Aggregate Reporting Group_]**.
4. Select **Save**.

[1]: #about-provisioned-pader-views
[2]: #configure-aggregate-reporting-groups