# 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 eTMF Vaults. In Clinical Operations Vaults with Veeva Site Connect, you can distribute them directly to clinical research sites. Streamlining object record and document creation reduces duplicate data and allows your organization to have a single source of truth within an organization.

Note: Depending on your Admin’s configuration , object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

## 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][1] 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 {#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 eTMF Vault as CrossLink documents. In Clinical Operations Vaults with Veeva Site Connect, you can distribute these documents directly to clinical research sites. In your Clinical Operations Vault, Vault classifies target CrossLinks based on Admin-defined mappings. When configured by your Admin, Vault also populates the _Product_ and _Study_ fields. If Vault does not populate the _Product_ field, CrossLink documents reference all _Studies_ referenced in the _Studies_ section of the _Distribution_ record, which Vault populates 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: 1. In your Safety Vault, navigate to the applicable _Case_ record. 2. 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**. 3. From the **All Actions** menu, select the **Send to Vault Clinical** action to transfer the data and documents to your Clinical Operations Vault. * In Clinical Operations Vaults with Veeva Site Connect, Vault creates the applicable _Safety Distribution_ with the CrossLink documents in your Clinical Operations Vault. 4. Optional: [Distribute Safety documents to sites][2] using Veeva Site Connect. ### 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.

[1]: #distributing-safety-letters [2]: #distributing-safety-documents