# Enable the Safety-Clinical Operations Connection: Safety Letters

With the 24R1 release, organizations with the Safety-Clinical Operations Connection enabled can transfer Safety Letters from their Safety Vault to their eTMF Clinical Operations Vault as CrossLink documents. This streamlines safety letter distribution by automating the availability of study data and documents between your Safety and Clinical Operations Vaults. In Clinical Operations Vaults with Veeva Site Connect, users can distribute these documents directly to clinical research sites.

Before starting the enablement instructions on this page, ensure you have <a href="/en/gr/53358/#how-to-establish-a-vault-to-vault-connection">established a connection</a> between your Safety and Clinical Operations Vaults.

Once you have completed the enablement instructions on this page, see the following resources:
* <a href="/en/gr/526180/">Configuring the Safety-Clinical Operations Connection</a> for more information about Integration configuration and more.
* <a href="/en/gr/526178/">About the Safety-Clinical Operations Connection</a> on how this connection works.

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      <p><strong>Note</strong>: If your Vault was provisioned in 24R1 or later, some of this configuration may already exist. Customers with Vaults before 24R1 must complete all the configuration steps listed on this page.</p>
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## Enable CrossLinks

In your Safety and Clinical Operations Vaults, <a href="/en/gr/23139/">enable CrossLinks</a>.

## Configure CrossLink Permissions

In your Safety and Clinical Operations Vaults, ensure the applicable security profiles include the **Create CrossLink** and **Create Document** permissions. See <a href="/en/gr/23139/#permissions">Configuring CrossLinks</a> for more details.

## Configure the Send to Vault Clinical User Action

In your Safety Vault, configure the **Send to Vault Clinical** user action:
1. Go to **Admin > Configuration > Objects > Transmission > Actions**.
2. Select **Create**.
3. In the dialog, select **Send to Vault Clinical**.
4. Select **Continue**.
5. Do one (1) of the following:
    * When assigning the action, select the **Available in All Lifecycle States** checkbox to apply <a href="/en/gr/47850/#configuring-atomic-security-on-user--system-actions">atomic action security</a> defaults and then select **Save**.
    * When assigning the action, select **Save** without selecting the **Available in All Lifecycle States** checkbox. Then, follow the steps to [configure the action on the **Transmission** lifecycle][1].

### <a id="configure-action-transmission-lifecycle"></a>Configure the Action on the Transmission Lifecycle

Add the action as a <a href="/en/gr/59885/">user action</a> to the applicable states of the **Transmission** lifecycle:
1. Go to **Admin > Configuration > Object Lifecycles > Transmission > [Lifecycle State]**.
2. In the **User Actions** section, select **Edit**.
3. Select **Create Rule**.
4. From the drop-down, select **Send to Vault Clinical**.
5. Enter an **Action Label**.
6. Select **Save**.

## Configure Veeva Site Connect

To distribute Safety Letters directly to clinical research sites using your Clinical Operations Vault, configure <a class="external-link " href="https://clinical.veevavault.help/en/gr/64233" target="_blank" rel="noopener">Veeva Site Connect<i class="fa fa-external-link" aria-hidden="true"></i></a> and <a class="external-link " href="https://clinical.veevavault.help/en/gr/65185" target="_blank" rel="noopener">Safety Distributions<i class="fa fa-external-link" aria-hidden="true"></i></a>.

## Configure Reference Lookups

In your Clinical Operations Vault, <a href="/en/gr/526180/#configuring_reference_lookups">configure reference lookups</a> to map document types.

## Map Vault Clinical Docs Artifacts

In your Clinical Operations Vault, map the **Expedited Safety Report** and **Safety Report Supporting Documents** artifacts:
1. Go to **Admin > Configuration > Document Types**.
2. Locate the classification you want to map, such as **Safety Reporting**, select its **Actions** menu, and select **Edit Details**.
3. Select the **Type Defaults** tab.
4. In the **Vault Clinical Docs** field in the **Reference Models** section, select the applicable [artifact][2].
5. Select **Save**.

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      <p><strong>Note</strong>: Do not associate either artifact with more than one (1) classification.</p>
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### <a id="artifacts"></a>Artifacts

<table>
<thead>
<tr>
<th>Safety Letter</th>
<th>Safety Document Type & Subtype</th>
<th>Safety Document Classification</th>
<th>Vault Clinical Docs Artifact</th>
</tr>
</thead>
<tbody>
<tr>
<td>Safety Document</td>
<td>Case > Individual Case Safety Reports (ICSR)</td>
<td><ul>
        <li>E2B Plus</li>
        <li>CIOMS I</li>
        <li>E2B(R2)</li>
        <li>E2B(R3)</li>
        <li>EMA E2B (R3)</li>
        <li>FDA 3500A</li>
        <li>FDA E2B(R2)</li>
        <li>FDA VAERS E2B (R3)</li>
        <li>PMDA E2B (R2)</li>
        <li>HC E2B (R2)</li>
    </ul>
</td>
<td>Expedited Safety Report</td>
</tr>
<tr>
<td>Cover Letter</td>
<td>Case > Individual Case Safety Reports (ICSR)</td>
<td>SUSAR Cover Letter</td>
<td>Safety Report Supporting Documents</td>
</tr>
</tbody>
</table>

[1]: #configure-action-transmission-lifecycle
[2]: #artifacts