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

Note: 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.

Enable CrossLinks

In your Safety and Clinical Operations Vaults, enable CrossLinks.

Configure CrossLink Permissions

In your Safety and Clinical Operations Vaults, ensure the applicable security profiles include the Create CrossLink and Create Document permissions. See Configuring CrossLinks for more details.

Configure the Send to Vault Clinical User Action

In your Safety Vault, configure the Send to Vault Clinical user action:

Go to Admin > Configuration > Objects > Transmission > Actions.
Select Create.
In the dialog, select Send to Vault Clinical.
Select Continue.
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:

Go to Admin > Configuration > Object Lifecycles > Transmission > [Lifecycle State].
In the User Actions section, select Edit.
Select Create Rule.
From the drop-down, select Send to Vault Clinical.
Enter an Action Label.
Select Save.

Configure Veeva Site Connect

To distribute Safety Letters directly to clinical research sites using 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:

Go to Admin > Configuration > Document Types.
Locate the classification you want to map, such as Safety Reporting, select its Actions menu, and select Edit Details.
Select the Type Defaults tab.
In the Vault Clinical Docs field in the Reference Models section, select the applicable artifact.
Select Save.

Note: Do not associate either artifact with more than one (1) classification.

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