# Enable Calculations and Statistical Data Creation for FAERS

With the 25R3 release, users can run _Signal Calculations_, create _Statistical Data_, and run signal alerts on FAERS data. After you have configured this feature, see the following resources for next steps: 
* <a href="/en/lr/753144/">Configure Signal Calculation Objects</a> to configure calculations for the FAERS data source
* <a href="/en/lr/808068/#signal-product-identifiers">Manage Signal Product Profiles</a> to configure _Signal Product Identifiers_ for each _Signal Product Profile_ associated with FAERS calculations
* [Configure Views & Default Workbench Dashboard][10]
* <a href="/en/lr/935430/">Signal Detection Overview</a>

## Update Health Authority Labels 

Update the following health authority labels: 
* [_Health Authority Database_ object][1]
* [_Health Authority Database_ object lifecycle][2]
* [_Health Authority_ record of the _Signal Source_ object][3]

### Update the Health Authority Database Object Label {#ha-object-label} 

To update the _Health Authority Database_ object:
1. Navigate to **Admin > Configuration > Objects > Health Authority Database**.
2. Select **Edit**. 
3. Update the _Object Label_ field to `Signal Source Data`.
4. Select **Save**.

### Update the Health Authority Database Object Lifecycle Label {#ha-object-lifecycle-label}

To update the _Health Authority Database Lifecycle_ object lifecycle label:
1. Navigate to **Admin > Configuration > Object Lifecycle > Health Authority Database Lifecycle**. 
2. Select **Edit**. 
3. Update the _Label_ field to `Signal Source Data Lifecycle`.

### Update the Health Authority Record Name {#ha-record-name}

To update the _Signal Source_ object _Health Authority_ record name: 
1. Navigate to **Business Admin > Objects > Signal Sources > Health Authority**.
2. Select **Edit**.
3. Update the **Name** to `Regulatory Database`.

## Update Signal Source Object Records

[Activate][4] and [update fields][5] on signal source object records. 

### Activate Object Records {#activate-records}

In **Business Admin > Objects**, set the following object records to the <a href="/en/lr/70436/#using-lifecycles">_Active_ lifecycle state</a>:
* _Signal Sources_ > _Regulatory Database_
* _Signal Source Data_ > _FDA - FAERS_
* _Signal Source Data_ > _EMA - EVDAS eRMR_

### Update the Signal Source and Agency on Object Records {#update-signal-source-agency-records}

In **Business Admin > Objects > Signal Source Data**, update the _Signal Source_ and _Agency_ fields for the following object records:
<table>
    <thead>
        <tr>
            <th>Object Record</th>
            <th>Signal Source</th>
            <th>Agency</th>
            <th>Default Workbench Dashboard</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>FDA - FAERS</em></td>
            <td><em>Regulatory Database</em></td>
            <td><em>FDA</em></td>
            <td>Select a <strong>Workbench Dashboard</strong> from the drop-down or select the <strong>Advanced Search</strong> (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-binoculars-icon.png" alt="binoculars-icon" style="" />) icon to use filters and refine your search.</td>
        </tr>
        <tr>
            <td><em>EMA - EVDAS eRMR</em></td>
            <td><em>Regulatory Database</em></td>
            <td><em>EMA</em></td>
            <td>This field applies to the FAERS data source only.</td>
        </tr>
    </tbody>
</table>

## Update Object Layouts

[Add][9] the _Data Source_ field to the appropriate layouts and then update the following object layouts:
* [_Signal Product Profile_][6]
* [_Signal Product Identifier_][7]
* [_Statistical Data_][8]

### Add the Data Source Field to Object Layouts {#data-source-field}

To add the _Data Source_ field to the required layouts:
1. <a href="/en/lr/26387/#columns">Add</a> the _Data Source_ field to the _Details_ section of the following object layouts: 
    * _Workbench View_ > _Workbench View Detail Page Layout_
    * _Signal Calculation_ > _Signal Calculation Detail Page Layout_
2. On the _Signal Calculations Setting_ object layout, <a href="/en/lr/26387/#columns">edit the default columns</a> for the _Signal Calculations_ section to include _Data Source_. 

### Update the Signal Product Profile Layout {#signal-product-profile}

To update the _Signal Product Profile_ <a href="/en/lr/26387/#object-type-layout">object layout</a>: 
1. Insert the _Signal Product Identifier_ <a href="/en/lr/26387/#how-to-add-sections">related object section</a>.
2. In the _Signal Product Identifier_ section, <a href="/en/lr/26387/#columns">edit the default columns</a> to include:
* _Data Source_
* _Identifier Type_
* _Identifier Value_

### Update the Signal Product Identifier Layout {#signal-product-identifier}

To update the _Signal Product Identifier_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields to the _Details_ section:
* _Signal Product Profile_
* _Data Source_
* _Identifier Type_
* _Identifier Value_

### Update the Statistical Data Layout {#statistical-data}

To update the _Statistical Data_ object layout:

1. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the following fields to the _Details_ section:
    * _Signal Source_
    * _Health Authority Database_
2. Navigate to the **Fields** tab and select <a href="/en/lr/15057/#customizestandardobjects">**Display in default lists and hovercards**</a> for the above fields.

## Update Data Source VQL on Workbench View Object

To update the criteria VQL for the _Data Source_ field on the _Workbench View_ object, follow the steps in <a href="/en/lr/1006100/#source-vql">Enable Calculations and Statistical Data Creation for VAERS</a>.

## Copy & Update FAERS Views

To copy and update FAERS safety views:
1. Navigate to **Business Admin > Objects > Workbench Views**. 
2. Use the table below to <a href="/en/lr/32218/#how-to-copy-records">copy</a> FAERS safety views so you can customize them according to your business needs. 
3. On each custom FAERS view, ensure the _Data Source_ field is set to **FAERS** and update <a href="/en/lr/753138/#dependent-views">dependent views</a> and <a href="/en/lr/753138/#sql-editor">SQL</a> as needed.

| Safety View | API Name |
| ----------------------------------------------------------- | ----------------------------------------------- |
| _Sample_FAERS – All Product-Event Combinations Principal_   | `sample_faers_all_pec_principal__c`             |
| _Sample_FAERS Interval Filter View_                         | `sample_faers_fv_interval__c`                   |
| _Sample_FAERS Cumulative Filter View_                       | `sample_faers_fv_cumulative__c`                 |
| _Sample_FAERS New Counts_                                   | `sample_faers_new_counts__c`                    |
| _Sample_FAERS Cumulative Counts_                            | `sample_faers_cumulative_counts__c`             |
| _Sample_FAERS EBGM - Age Group, Gender, Receipt Year Strata_ | `sample_faers_ebgm_ag_sex_ryr__c`              |
| _Sample_FAERS Case Series - New Counts_                     | `sample_faers_case_series_new_counts__c`        |
| _Sample_FAERS Case Series - Cumulative Counts_              | `sample_faers_case_series_cumulative_counts__c` |

## Grant Permissions

Ensure your <a href="/en/lr/22824/#objectpermissions">permission sets</a> are updated to grant the appropriate level of access for Admins and users to objects, fields, and tabs according to your organization's process. Manage permissions from **Admin > Users & Groups > Permission Sets > [Permission Set]**.

Update the relevant permission set to grant _Read_, _Create_, _Edit_, and _Delete_ permissions for the _Signal Product Identifier_ object. 

## Next Steps: Configure Views & Default Workbench Dashboard {#next-steps}

To analyze your FAERS data in _Workbench Reports_ and _Workbench Dashboards_:
1. <a href="/en/lr/753138/#create-and-access-safety-views">Configure a _Principal View_</a> that queries FAERS data. You can use the provided FAERS views for reference. Ensure the _Data Source_ is set to _FAERS_.
2. <a href="/en/lr/825938/">Configure _Signal Views_</a> as needed for analysis. Ensure the _Data Source_ is set to _FAERS_.
3. <a href="/en/lr/825938/#assign-the-case-version-key-on-principal-views">Enable _Case_ series</a> on the FAERS _Principal View_.
4. <a href="/en/lr/774233/#create-workbench-dashboards">Create a _Workbench Dashboard_</a> for FAERS.
5. In **Business Admin > Objects**, set the _Default Workbench Dashboard_ to the created FAERS dashboard for the following records:
    * _Signal Source Data_ > _FDA - FAERS_
    * _Signal Product Profile_ > [FAERS _Signal Product Profile_] 

<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>: To use <em>Workbench Reports</em> and <em>Workbench Dashboards</em>, you must obtain a <a href="/en/lr/752926/">Veeva Safety Workbench</a> license.</p>
    </div>
  </div>
</div>



[1]: #ha-object-label
[2]: #ha-object-lifecycle-label
[3]: #ha-record-name
[4]: #activate-records
[5]: #update-signal-source-agency-records
[6]: #signal-product-profile
[7]: #signal-product-identifier
[8]: #statistical-data
[9]: #data-source-field
[10]: #next-steps