# Enable FDA FAERS E2B(R3) Submissions & Distributions

To support ICSR transmissions to the FDA in FDA FAERS E2B(R3) format, Safety introduces the following _Transmission Profiles_:

* **CDER Study:** Used for study data transmissions to the Center for Drug Evaluation and Research (CDER)
* **CBER Study:** Used for study data transmissions to the Center for Biologics Evaluation and Research (CBER)
* **CDER IND Exempt:** Used for study data transmissions for marketed products that are exempt from Investigational New Drugs (IND) requirements

Although the _Transmission Profiles_ for the FDA FAERS E2B(R3) Submissions and Distributions feature was released in 24R1, this article is published with 24R2 to support the release of the <a href="/en/lr/725757/">FDA FAERS E2B(R3) feature</a>.

### 26R1 Update: FDA FAERS E2B(R3): Primary Study Selection for Cross Reporting

With the 26R1 release, you can designate a primary _Study Registration_ for _Studies_ in their _Library_. This is useful when exporting cross-reported studies to FDA FAERS E2B(R3) files to ensure that Vault populates the correct _Study Registration Number_ in the FDA.C.5.5a data element. After [configuring][1] this feature, see <a href="/en/lr/01216/#fda-ind-primary">Manage Studies</a> and <a href="/en/lr/725757/#fda-ind">E2B Generation: FDA FAERS E2B(R3) Mapping</a> for more information.

### Related Feature Enablement

To support device and combination product _Cases_ reporting through the FDA FAERS E2B(R3) format, ensure you have <a href="/en/lr/654889/">enabled the Update to Seriousness Picklist feature</a>.

## Additional Consideration

Vault uses global ICH E2B(R3) validations to evaluate FDA FAERS E2B(R3) files. However, Safety does not include FDA-specific validations for this format. We recommend that you <a href="/en/lr/01461/">configure custom Validation Criteria</a> if you want to enforce FDA-specific business rules.

## Activate the Transmission Profiles

All Vaults include the _Transmission Profiles_ for FDA FAERS E2B(R3) exports, but they are inactive. To activate them:

1. Navigate to **Business Admin > Objects > Transmission Profiles**.
2. Select the _Transmission Profile_ you want to activate.
3. In the **Object State** drop-down, select **Active**.
4. In the **Change Object Status** dialog, select **Yes**.

## Configure Submissions

To configure test submissions for sandbox or validation Vaults and submissions for production Vaults, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _FDA Batch Receiver Identifier_ and _FDA Message Receiver Identifier_ fields to all applicable _Transmission Profile_ object layouts based on your business process.

### Configure Transmission Profiles for Test Submissions

To configure test submissions in sandbox or validation Vaults, update the following _Transmission Profiles_ and fields:

<table>
    <thead>
        <tr>
            <th>Transmission Profile</th>
            <th>FDA Batch Receiver Identifier Field</th>
            <th>FDA Message Receiver Identifier Field</th>
            <th>Routing ID Field <sup><a href="#routing-id-footnote-a">1</a></sup></th>
            <th>FDA Center</th>
            <th>Submission Type</th>
         </tr>
      </thead>
      <tbody>
          <tr>
            <td><em>CBER</em></td>
            <td>Enter <code>ZZFDATST</code></td>
            <td>Enter <code>CDER</code></td>
            <td>Enter <code>FDA_AERS</code></td>
            <td>CBER</td>
            <td>AERS</td>
          </tr>
        <tr>
            <td><em>CBER Study</em></td>
            <td>Enter <code>ZZFDATST_PREMKT</code></td>
            <td>Enter <code>CBER_IND</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CBER</code></td>
            <td>CBER</td>
            <td>AERS_PREMKT_CBER</td>
        </tr>
        <tr>
            <td><em>CDER</em></td>
            <td>Enter <code>ZZFDATST</code></td>
            <td>Enter <code>CDER</code></td>
            <td>Enter <code>FDA_AERS</code></td>
            <td>CDER</td>
            <td>AERS</td>
        </tr>
        <tr>
            <td><em>CDER Study</em></td>
            <td>Enter <code>ZZFDATST_PREMKT</code></td>
            <td>Enter <code>CDER_IND</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CDER</code></td>
            <td>CDER</td>
            <td>AERS_PREMKT_CDER</td>
        </tr>
        <tr>
            <td><em>CDER IND Exempt</em></td>
            <td>Enter <code>ZZFDATST_PREMKT</code></td>
            <td>Enter <code>CDER_IND_EXEMPT_BA_BE</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CDER</code></td>
            <td>CDER</td>
            <td>AERS_PREMKT_CDER</td>
        </tr>
        <tr>
            <td colspan="6"><a id="routing-id-footnote-a"></a>1. Enter the <strong>Routing ID Field</strong> value exactly as shown, which for some <em>Transmission Profiles</em> (<em>CBER Study</em>, <em>CDER Study</em>, and <em>CBER IND Exempt</em>) contains a space.</td>
        </tr>
      </tbody>
</table>

### Configure Transmission Profiles for Submissions

To configure submissions in production Vaults, you can leave the _FDA Batch Receiver Identifier_ and _FDA Message Receiver Identifier_ fields blank or update the following _Transmission Profiles_ and fields:

<table>
    <thead>
        <tr>
            <th>Transmission Profile</th>
            <th>FDA Batch Receiver Identifier Field</th>
            <th>FDA Message Receiver Identifier Field</th>
            <th>Routing ID Field <sup><a href="#routing-id-footnote-b">1</a></sup></th>
            <th>FDA Center</th>
            <th>Submission Type</th>
         </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>CBER</em></td>
            <td>Enter <code>ZZFDA</code></td>
            <td>Enter <code>CDER</code></td>
            <td>Enter <code>FDA_AERS</code></td>
            <td>CBER</td>
            <td>AERS</td>
        </tr>
        <tr>
            <td><em>CBER Study</em></td>
            <td>Enter <code>ZZFDA_PREMKT</code></td>
            <td>Enter <code>CBER_IND</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CBER</code></td>
            <td>CBER</td>
            <td>AERS_PREMKT_CBER</td>
        </tr>
        <tr>
            <td><em>CDER</em></td>
            <td>Enter <code>ZZFDA</code></td>
            <td>Enter <code>CDER</code></td>
            <td>Enter <code>FDA_AERS</code></td>
            <td>CDER</td>
            <td>AERS</td>
        </tr>
        <tr>
            <td><em>CDER Study</em></td>
            <td>Enter <code>ZZFDA_PREMKT</code></td>
            <td>Enter <code>CDER_IND</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CDER</code></td>
            <td>CDER</td>
            <td>AERS_PREMKT_CDER</td>
        </tr>
        <tr>
            <td><em>CDER IND Exempt</em></td>
            <td>Enter <code>ZZFDA_PREMKT</code></td>
            <td>Enter <code>CDER_IND_EXEMPT_BA_BE</code></td>
            <td>Enter <code>FDA_AERS_PREMKT_&nbsp;CDER</code></td>
            <td>CDER</td>
            <td>AERS_PREMKT_CDER</td>
        </tr>
        <tr>
            <td colspan="6"><a id="routing-id-footnote-b"></a>1. Enter the <strong>Routing ID Field</strong> value exactly as shown, which for some <em>Transmission Profiles</em> (<em>CBER Study</em>, <em>CDER Study</em>, and <em>CBER IND Exempt</em>) contains a space.</td>
        </tr>
    </tbody>
</table>

## (26R1) Configure FDA FAERS E2B(R3): Primary Study Selection for Cross Reporting {#r261}

To configure your Vault for this feature, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _FDA Primary IND_ field to the applicable _Study Registration_ object layouts.

[1]: #r261