About the Safety-Clinical Operations Connection

Using the Safety-Clinical Operations Connection, organizations with both a Safety Vault and Clinical Operations Vault can exchange data in near-real time. This connection transfers Study and Study Country (Study Registration) records from your Clinical Operations Vault to your Safety Vault. You can also send Safety Letters about Serious Adverse Events (SAEs) from your Safety Vault to your Clinical Operations Vaults with Veeva Site Connect and then distribute them directly to sites. Streamlining object record and document creation reduces duplicate data and allows your organization to have a single source of truth within an organization.

How the Safety-Clinical Operations Connection Works

The Safety-Clinical Operations Connection creates new records, updates existing records, and creates CrossLink documents across Vaults in the following situations:

When a user creates or edits a Study record in the Clinical Operations Vault, Vault creates or updates the Study record in the Safety Vault.
When a user creates or edits a Study Country record in the Clinical Operations Vault, Vault creates or updates the Study Registration record in the Safety Vault.
When a user runs the Submit to Clinical Vault action on a Distribution in the Safety Vault, Vault transfers Safety Letters to the Clinical Operations Vault.
- Vault creates a Safety Distribution in the Clinical Operations Vault with the applicable CrossLink documents.
When a user updates a transferred Safety Distribution’s lifecycle state in the Clinical Operations Vault, Vault updates the corresponding Distribution record’s lifecycle state in the Safety Vault:
- When a user updates a Safety Distribution’s lifecycle state to Ready, Vault updates the corresponding Distribution record’s lifecycle state to Pending Distribution.
- When a user updates a Safety Distribution’s lifecycle state to Distributed, Vault updates the corresponding Distribution record’s lifecycle state to Sent.

About Record Creation & Update

Vault creates new records in their lifecycles’ starting states. When creating a record through the connection, Vault also populates the Link (link__sys) field on the target record with the source record’s Global ID (global_id__sys). These fields let Vault know which records to update in the target Vault when you update data in the source Vault.

Distributing Safety Letters

The Safety-Clinical Operations Connection allows you to gather documentation and data on an SAE from multiple sources for distribution to relevant sites. Distribution Managers can send Safety Letters such as CIOMS reports and FDA 3500 forms with optional cover letters from your Safety Vault to your Clinical Operations Vault to distribute directly to sites with Veeva Site Connect.

About Safety Letter Transfer

In your Clinical Operations Vault, Vault classifies target CrossLinks based on Admin-defined mappings. CrossLink documents reference all Studies referenced in the Studies section of the Distribution record. Vault populates this section based on the Products specified in the related Case.

Vault creates the target Safety Distribution in your Clinical Operations Vault with data from the source Distribution in your Safety Vault:

Source Distribution Record	Target Safety Distribution Record
File	Safety Document
Cover Letter	Supporting Document
Due Date	Due Date
Study of the related Case	Study of Origin
Event Country of the related Case	Country of Origin

Sending Safety Letters to your Clinical Operations Vault

To send Safety Letters from your Safety Vault to your Clinical Operations Vault:

In your Safety Vault, navigate to the applicable Case record.
Create a Distribution for the Study Case by running the Evaluate Reporting Obligations action on a SUSAR Case or creating the record manually.
1. For Transmission Profile, select Vault Clinical.
2. For Destination, select Vault Clinical.
3. For Transmission Document Type, select one (1) of the following options:
  - CIOMS I
  - E2B Plus
  - E2B (R2)
  - E2B (R3)
  - EMA E2B (R3)
  - FDA 3500A
  - FDA E2B(R2)
  - FDA VAERS E2B (R3)
  - HC E2B (E2)
  - PMDA E2B (R2)
4. In the File field, select the applicable Safety document.
5. Optional: In the Cover Letter field, select the applicable document.
6. Enter the Due Date. This field may already be populated. If applicable, you can modify the value.
7. For Patient Content Protection, select Mask PII or Masked E2B (Includes PII).
8. When you’ve populated all relevant fields, click Save.
From the All Actions menu, select the Send to Vault Clinical action to transfer the data and documents to your Clinical Operations Vault. Vault creates the applicable Safety Distribution with the CrossLink documents in your Clinical Operations Vault.
Distribute Safety documents to sites.

Distributing Safety Documents

After you send Safety Letters to your Clinical Operations Vault, you can distribute them to sites with Veeva Site Connect. When you update the state of the Safety Distribution in your Clinical Operations Vault to Ready, Vault updates the source Distribution in your Safety Vault to the Pending Distribution state. When you run the Distribute to Sites action on the Safety Distribution, Vault updates the source Distribution to the Sent state.

Updating CrossLinks & Distributions

If you have to update the CrossLink documents after sending them to your Clinical Operations Vault, make the updates in your Safety Vault. Vault does not update CrossLink documents in your Safety Vault to reflect changes you make to the documents in your Clinical Operations Vault.

If you need to update a Distribution after sending it to your Clinical Operations Vault, you must create a new Distribution and send that to your Clinical Operations Vault.

Note: Do not update an existing Distribution in your Safety Vault and re-send it to your Clinical Operations Vault. If you update a Safety Distribution in your Clinical Operations Vault, Vault does not send the update to your Safety Vault.