Enable the Safety-Clinical Operations Vault Connection: Safety Letters

Learn how to configure your Safety Vault to enable the Safety-Clinical Operations Vault Connection: Safety Letters feature.

About the Feature

In 24R1, organizations with the Safety-Clinical Operations Vault Connection enabled can now transfer Safety Letters from their Safety Vault to their Clinical Operations Vault with Veeva Site Connect. This allows you to utilize the Safety-Clinical Operations Vault Connection to create Safety Distributions and related CrossLink documents in your target Clinical Operations Vault from Distributions data and documents in your source Safety Vault.

Before starting the enablement instructions on this page, ensure you have established a Vault to Vault connection between your Safety and Clinical Operations Vaults.

Once you have completed the enablement instructions on this page, see the following resources:

• Configuring the Safety-Clinical Operations Vault Connection for more information about Integration configuration and more.
• About the Safety-Clinical Operations Vault Connection on how this connection works.

Enable CrossLinks

In your Safety and Clinical Operations Vaults, enable CrossLinks:

1. Go to Admin > Settings > General Settings > CrossLinks.
2. Select Edit.
3. In the CrossLinks section, select the Enable CrossLink Documents checkbox.
4. Select Save.

For more information, see CrossLink Administration.

Configure CrossLink Permissions

In your Safety and Clinical Operations Vaults, ensure the applicable security profiles include the Create CrossLink and Create Document permissions. See CrossLink Administration 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 atomic action security 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.

Configure the Action on the Transmission Lifecycle

Add the action as a user action 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

In your Clinical Operations Vault, configure Veeva Site Connect and Safety Distributions .

Configure Reference Lookups

In your Clinical Operations Vault, configure reference lookups 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.
5. Select Save.

Artifacts

Safety Letter	Safety Document Type & Subtype	Safety Document Classification	Vault Clinical Docs Artifact
Safety Document	Case > Individual Case Safety Reports (ICSR)	E2B Plus CIOMS I E2B(R2) E2B(R3) EMA E2B (R3) FDA 3500A FDA E2B(R2) FDA VAERS E2B (R3) PMDA E2B (R2) HC E2B (R2)	Expedited Safety Report
Cover Letter	Case > Individual Case Safety Reports (ICSR)	SUSAR Cover Letter	Safety Report Supporting Documents