Organizations using both a RIM Submissions Vault and a Clinical Operations eTMF Vault can use a standard Vault to Vault connection. The RIM to Clinical Operations connection transfers Product Family, Clinical Study, and Site records across Vaults and automates the creation, versioning, and updating of CrossLink documents and document fields. Streamlining object record and document creation reduces duplicate data and allows Vault documents to have a single source of truth within an organization.
Note: The RIM to Clinical Operations Vault Connection is only available for organizations with both a Submissions Vault and eTMF Vault.
How the RIM to Clinical Operations Vault Connection Works
The RIM to 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 Product Family record in the Submissions Vault, Vault creates or updates the Product record in the eTMF Vault.
- When a user creates or edits a Study record in the eTMF Vault, Vault creates or updates the Clinical Study record in the Submissions Vault.
- When a user creates or edits a Study Product record in the eTMF Vault, Vault creates or updates the Product Family Clinical Study record in the Submissions Vault.
- When a user creates or edits a Site record in the eTMF Vault, Vault creates a Clinical Site record under the same Clinical Study record in the Submissions Vault and populates the Site Country field based on Study Country in the eTMF Vault.
- When a document enters its Steady state in the source Vault, Vault creates or versions a CrossLink document in the target Vault and populates fields. Admins can also configure Vault to transfer document versions to the connected Vault when they reach the source Vault’s Superseded state. An Admin defines CrossLink document behavior in the connection’s configuration. See details about document creation below.
When users delete documents or object records in one Vault, Vault does not delete the associated documents or object records in the connected Vault.
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 data is updated in the source Vault.
About Document Creation & Update
Vault creates new CrossLink documents in the lifecycle state defined in the connection’s configuration. If the document’s type has multiple lifecycles, Vault applies the first lifecycle available. Because Vault creates CrossLink documents through the Vault REST API, it does not apply document lifecycle role defaults. Vault creates CrossLink documents in the target Vault differently depending on source binding rules. See details about source binding rules below.
Vault can also make the following updates to existing CrossLink documents in the target Vault:
- When a source document enters its Steady state, Vault moves the existing CrossLink document in the target Vault to a new lifecycle state defined in the connection’s configuration. Vault also applies any entry actions configured on that lifecycle state, for example, setting the version number to a major version.
- If multiple instances of a CrossLink document exist in a target Vault, Vault updates the CrossLink document bound to the highest document version in the source Vault.
- When enabled by an Admin, Vault transfers any Superseded versions of a document created since the last time the connection ran.
- If there are both Steady state and Superseded versions of the source document in the source Vault that have not been transferred to the target Vault since the last time the connection ran, Vault transfers all of these document versions.
- If the connection has never run, Vault only transfers the latest Steady state version of the document.
- Document versions created in the target Vault are set by the target Vault and bound to the versions from which they were created in the source Vault.
- When the fields on a Steady state source document are modified in the source Vault, Vault updates those fields on the CrossLink document in the target Vault.
Note: Vault does not apply document reuse functionality to CrossLink documents in eTMF Vaults that were transferred from Submissions Vaults.
About Source Binding Rules
If a CrossLink document does not already exist in the target Vault, Vault creates the CrossLink document and binds it to the current document version in the source Vault. Vault will then update the CrossLink document only if a user in the source Vault specifically edits the version of the source document that is bound.
All CrossLink documents created via the RIM to Clinical Operations Vault Connection have the Source Binding Rule set to Specific Document Version.