# Configuring the RIM-Clinical Operations Connection Organizations using both a RIM Vault and a Clinical Operations Vault on the same domain can use a standard Vault to Vault connection. The RIM-Clinical Operations connection transfers _Product Family_, _Clinical Study_, and Clinical _Site_ records, as well as regulatory data, across Vaults. The connection also automates the creation, versioning, and updating of CrossLink documents and fields. See About the RIM-Clinical Operations Connection for detailed information about how the connection works.

Note: The RIM-Clinical Operations Connection is only available for organizations with both a RIM Vault and Clinical Operations Vault on the same domain. Additionally, the Submission Tracking Integration requires the Study Startup (SSU) application to be enabled in Clinical Operations.

## RIM-Clinical Operations Connection Components The following components support the standard Vault to Vault RIM-Clinical Operations Connection. ### Connections The following _Connection_ records are available from **Admin > Connections**: * _Clinical to RIM Connection_ (`clinical_to_rim_connection__v`) is available in your Clinical Operations Vault * _RIM to Clinical Connection_ (`rim_to_clinical_connection__v`) is available in your RIM Vault You will still need to establish the Vault to Vault connection before you can use it.

Note: RIM Vaults also include the RIM Local Connection, which Vault uses to run source document publishing actions as the Application Owner. It must always remain active and does not require any Admin interaction.

### Integration & Integration Points {#integration-points} The _Integration_ and _Integration Point_ objects enable Vault to manage the message queues and define what documents and data the connection maps from one Vault to another. These records are read-only and are used by Vault to manage the connection and track any connection errors. ### RIM Integrations & Integration Points The _RIM to Clinical Connection_ record includes the following default _Integration_ records with standard _Integration Point_ records in your RIM Vault:

Integration Name	Integration Point Name(s)	Sent From	Sent To	Included Data
Product Family Integration	Product Family Outbound Integration Point	RIM	Clinical Operations	Name Global ID
Clinical Study Integration	Clinical Study Inbound Integration Point	Clinical Operations	RIM	Clinical Study Number Primary Product Family Study Description Study Type Type of Control Study Subtype Link
Product Family Clinical Study Integration	Product Family Clinical Study Inbound Integration Point	Clinical Operations	RIM	Clinical Study Product Family Link
Clinical Site Integration	Clinical Site Inbound Integration Point	Clinical Operations	RIM	Site Name Study Site Country Site Lead Investigator Link
Inbound Documents	Inbound Documents Integration Point	Clinical Operations	RIM	Clinical Study Name Title Product Family Description Redacted Link Version Link Major Version Minor Version
Outbound Documents	Outbound Documents Integration Point	RIM	Clinical Operations	Clinical Study Name Title Global ID Global Version ID Product Family Description
Submission Tracking Integration	Submission Tracking Outbound Integration point	RIM	Clinical Operations	Planned Approval/ Authorization Date Planned Submission Date Actual Submission Date Number of RIM CTR Part I Verdict Actual Decision Date CTR Interim Verdict CTR Interim Verdict Date Country Decision Detail Lifecycle State Country Decision Date

### Clinical Operations Integrations & Integration Points The _Clinical to RIM Connection_ record includes the following default _Integration_ records with standard _Integration Point_ records in your Clinical Operations Vault:

Integration Name	Integration Point Name(s)	Sent From	Sent To	Included Data
Product Integration	Product Inbound Integration Point	RIM	Clinical Operations	Product Name Link
Study Integration	Study Outbound Integration Point	Clinical Operations	RIM	Study Number Product Protocol Title Study Type Global ID
Study Site Integration	Study Site Inbound Integration Point	Clinical Operations	RIM	Study Site Number Study Number Study Country Global ID
Inbound Documents	Inbound Documents Integration Point	RIM	Clinical Operations	Clinical Study Name Title Global ID Global Version ID Product Family Description
Outbound Documents	Outbound Documents Integration Point	Clinical Operations	RIM	Clinical Study Name Title Product Family Description Link Version Link Major Version Minor Version
Submission Tracking Integration	Clinical Trial Submission Clinical Trial Approval EU CTR Part I EU CTR Part II EU CTR Final Approval	Clinical Operations	RIM	Planned Finish Date Initial Planned Submission Date Initial Submission Date Planned Submission Date Actual Submission Date Number of Submissions Submission Decision Submission Decision Date Actual Finish Date Country Decision Date

### Integration Rules {#integration-rules} To support the RIM-Clinical Operations Connection, it may be necessary to transform data from the source Vault's data model to fit within the target Vault's data model. You can use Integration Rules to incorporate configurable rules for mapping object and document fields between two Vaults. Learn more about creating and managing Integration Rules . ### Queues This feature includes four standard message processing queues : two in your RIM Vault and two in your Clinical Operations Vault. You can access and manage these queues from **Admin > Connections > Spark Queues**. In your Clinical Operations Vault, you have: * _RIM to Clinical inbound queue_ (`rim_clinical_inbound_queue__v`) * _Clinical to RIM outbound queue_ (`clinical_rim_outbound_queue__v`) In your RIM Vault, you have: * _Clinical to RIM inbound queue_ (`clinical_rim_inbound_queue__v`) * _RIM to Clinical outbound queue_ (`rim_clinical_outbound_queue__v`) ### User Exception Objects {#user-exception-objects} Vault includes the _User Exception Message_ object and its child object, _User Exception Item_, to help you track and resolve any errors that occur with your RIM-Clinical Operations Connection. If either end of your integration can't process an incoming message, Vault creates a _User Exception Message_ record to capture the failure. Vault also creates individual _User Exception Item_ records for each item that failed on the related _Integration Point_ record in the outbound Vault. You can view and manage these messages from **Admin > Connections > User Exception Messages**. A _User Exception Message_ means that you need to update your configuration. After you update the configuration, Vault attempts to resolve any errors the next time the connection runs. You can also select the **Rerun Integration** action to run the connection and resolve errors. Vault retries all active User Exception Items until they are resolved. To prevent reprocessing of the same failed items, Admins can manually inactivate specific _User Exception Items_ or the parent _User Exception Message_. The next time the connection runs, it will only query for active items and messages to reprocess. ### Standard Document Type Groups {#document-type-groups} The following _Document Type Group_ records are available to support this connection: * _Clinical to RIM Connection_ is available in your Clinical Operations Vault * _RIM to Clinical Connection_ is available in your RIM Vault Vault uses these document type groups to determine which document types to transfer from one Vault to another. When a document belonging to one of these groups enters its _Steady_ state, Vault sends a Spark message to create a CrossLink document in the connected Vault and updates the document fields to reflect changes made to the document in the source Vault. If configured, Vault also sends _Superseded_ versions of documents created since connection last ran. You must configure a [_Document Type_ reference lookup][8] to map the document type in the source Vault to the document type in the target Vault in order for Vault to transfer documents. ### Standard Document State Types {#state-types} The following _Document State Types_ are available to support this connection: * _Inbound Transfer_ is available on document lifecycles in your Clinical Operations Vault * _Inbound_ is available on document lifecycles in your RIM Vault Vault creates documents that are transferred through the connection in the states that you assign to these state types. Learn more about defining document state types . The Steady State _Approved_ must be associated to these State Types.

Note: In most cases, the inbound document state types should be associated with the Steady state.

### Last Successful Run Field On every inbound _Integration_ record, the _Last Successful Run_ field captures the date and time that the integration last ran with no message processing errors. Vault uses this date to query changes since the integration's last successful run. If you don't want Vault to transfer existing object records or existing _Steady_ state documents as CrossLink documents, set this field to the date and time when you will activate the connection. When activating the connection, set the _Last Successful Run_ field on each active _Integration_ to the date and time that you want transfers to start. If you do not set a value on the _Last Successful Run_ field, Vault will transfer all relevant records and documents. ## Configuring the RIM-Clinical Operations Connection You must complete the following steps in both your RIM Vault and your Clinical Operations Vault to configure the standard connection: 1. Define reference lookups for controlled fields within the integration scope and load these to each Vault. See details about [configuring reference lookups][8] below. 2. Update any required fields that are not defined in the connection to either have a default value or to make values not required. See details about [updating fields][10] below. 3. Update existing records and CrossLink documents to prevent Vault from creating duplicates when the connection runs. See [instructions and information about object record creation][11] below. 4. Ensure the connection's [standard _Document Type Groups_][12] are set to _Active_ and add all necessary document types to each group. 5. Update document lifecycles to assign document states to the connection's [standard document state types][13]. In both Vaults, we recommend setting the connection's document state types to the _Approved_ state. 6. Assess and update document lifecycle entry criteria and entry actions. CrossLinks respect criteria configured on a lifecycle's Steady State, and therefore any configured entry criteria and entry actions must be reviewed to ensure they do not prevent the connection from successfully transferring CrossLinks. * Source documents must meet all configured entry criteria and entry actions. For example, when entry criteria is conditional such that a date field is blank, the source document must include this field (and the field must be blank at the time of transfer) in order for its CrossLink to be created. * CrossLink renditions are uploaded asynchronously. For any entry criteria where Vault validates that content has been uploaded, the rule must be updated to conditionally exclude CrossLinks. 1. Enable CrossLinks. See [details about this step][14] below. 2. Optional: Enable the transfer of _Steady_ state and _Superseded_ document versions. See [details about this step][15] below. 3. In Vaults created before 19R3, contact Veeva Support to request that they generate Global ID values for the _Product Family_ object in your RIM Vault and for the _Clinical Study_, _Study Site_, and _Study Product_ objects in your Clinical Operations Vault. The connection uses the _Global ID_ field to transfer data across Vaults. 4. We recommend that you create a flash report to run when there are active _User Exception Message_ records in either Vault. 5. Establish the Vault to Vault connection between your RIM Vault and your Clinical Operations Vault. See Creating & Managing Connections for detailed instructions. 6. Optional: By default, when the Clinical source document does not include a _Product_ value, Vault defaults _Products_ on the RIM CrossLink based on the _Product Family Clinical Study_ relationship for every _Study_ referenced by the source document. Contact Veeva Support to enable an optional setting by which Vault instead defaults _Products_ on the RIM CrossLink based on the _Primary Product Family_ assigned to the _Study_ referenced by the source document. If you don't complete these steps in both Vaults, the connection will not work. ## Configuring Reference Lookups {#reference-lookups} Reference lookups are a configuration component referenced by [integration rules][17] that allow you to map the value of a field on a target object or document indirectly from a value in the source Vault. When you configure the connection, you need to add reference lookups for controlled fields within the integration scope. We recommend creating CSV mapping files and loading these to your Vault to create reference lookups. For example, in order for Vault to transfer documents from one Vault to the other, you need to create _Document Type_ reference lookups to map the source document types to the target document types. See Creating & Managing SDK Reference Lookups for detailed instructions. If _Document Type_ reference lookups are not defined in your connection configuration, Vault will attempt to assign document types to CrossLink documents in RIM Vaults based on the RIM Reference Model configuration. See Setting Up the RIM Reference Model for details. ### Loading Mappings After you create CSV mapping files for documents and object records, you can use Vault Loader to load reference lookups to your Vault: 1. Navigate to the **Loader** tab. 2. Select your **CSV File**. See the sample _Object_ mapping file and the sample _Document Type_ mapping file. 3. In the **Object Type** drop-down, select _Reference Lookups_. 4. In the **Action Type** field, select _Create_. 5. Click **Start Load**. Load _Document Type_ and _Object_ reference lookups in your Clinical Operations and RIM Vaults. After you load reference lookups, confirm they loaded successfully. Then, navigate to **Admin > Connections** in each Vault and review the reference lookups to ensure they appear as expected. ## Updating Fields {#updating-fields} In order for the connection to run successfully, you need to update any required document or object fields that are not defined in the connection to either have a default value or to make values not required. For example, in the RIM Vault, update the _Principal Investigator_ field on the _Site_ object. Keeping _Principal Investigator_ as a required field will cause errors when _Site_ records missing a _Principal Investigator_ value are created or updated when the connection runs if you didn't extend the _Integration Rules_. ### Object Fields Update fields to be optional or to have a default value on the _Clinical Study_, _Clinical Site_, and _Product Family Clinical Study_ objects in your RIM Vault, and on the _Product_ object in your Clinical Operations Vault. In addition, you must make the following updates in your RIM Vault: * Add the _Site Country_ (`site_country__v`) field to the _Site_ object page layout. * If your Vault has object types enabled on the _Clinical Study_, _Clinical Site_, or _Product Family Clinical Study_ objects, add the _Link_ (`link__sys`) field to each object type. ### Document Fields In addition to updating document fields to be optional or to have a default value, you need to configure field-level security on the _Major Version Number_ document field on the _Base Document_ type. In both Vaults, add an _Editable_ security override for the _Application Owner_ account. Vault will update the _Minor Version Number_ field automatically to respect the same override. You also need to activate the following field rules to enable the transfer of these field values to the existing RIM fields: * _Ready for Publishing_ * _Redacted_ ## Updating Existing Object Records & CrossLink Documents {#creation} ### Object Records When creating an object record as part of the connection, Vault populates the _Link_ (`link__sys`) field on the target record or CrossLink with the _Global ID_ (`global_id__sys`) of the source record. These fields let Vault know which records to update in the target Vault when data is updated in the source Vault. If your Vault contains existing records that you want the connection to update, you can manually enter the _Global ID_ value from the source record in the _Link_ field on the target record. Once the connection is active, Vault will update these existing records rather than creating new ones. In your RIM Vault, update existing _Clinical Study_, _Clinical Site_, and _Product Family Clinical Study_ records that have corresponding records in your Clinical Operations Vault. In your Clinical Operations Vault, update existing _Product_ records. ### CrossLink Documents If your Vault contains existing CrossLink documents bound to a specific _Steady_ state version and you don't want Vault to create duplicates when the connection runs, you can: * Enter the _Global ID_ value from the source document in the _Link_ field on the CrossLink document * Enter the _Global Version ID_ value from the source document in the _Document Version Link_ field on the CrossLink document ## Enabling CrossLinks {#crosslinks} CrossLink documents enable content from one Vault to be used in another Vault within the same domain. In order for the connection to create documents across both your RIM and your Clinical Operations Vaults, you'll need to enable CrossLinks in both Vaults. When you enable CrossLinks, you can also choose to exclude document overlays and signature pages from the document in the source Vault when Vault creates the CrossLink document in the target Vault. We recommend including source document overlays and signature pages in your Clinical Operations Vault but excluding them in your RIM Vault.

Note: Vault does not apply document reuse functionality to CrossLink documents in Clinical Operations Vaults that were transferred from RIM Vaults.

## Transferring Steady State & Superseded Document Versions {#version-transfer} When enabled, Vault can transfer all _Steady_ state and _Superseded_ document versions between Vaults when the Connection runs. When users create multiple versions of the same document within a five-minute window, Vault recognizes all versions created (_Steady_ state and _Superseded_) since the last time the Connection ran and creates them as CrossLinks. If a CrossLink already exists for the specific document version in the target environment, Vault automatically updates the CrossLink metadata to match the source document. To prevent any performance issues in your Vault, contact Veeva Support to enable this feature's related setting, _RIM to Clinops Connection: Transfer steady and superseded state document versions_. When disabled, Vault only transfers the most recent Steady state version created since the last time the Connection ran. When enabled, Vault creates a CrossLink for the updated version and any missing superseded versions, provided a higher version does not already exist in the target Vault. **Known Limitation**: Creating multiple _Steady_ state document versions in the source Vault via the **Upload New Version** action does not create multiple CrossLinks in the target Vault. ## Transferring Regulatory Tracking Information for Clinical Trial Approvals {#transferring-regulatory-tracking} When enabled, the Submission Tracking Integration sends relevant regulatory tracking information about initial clinical trial approvals from various RIM objects including _Regulatory Objective_, _Country Decision Detail_, and _Submission_, to Clinical _Milestones_ via the RIM-Clinical Operations Connection. Vault transfers dates for initial global clinical trial approval procedures, such as US INDs, Canadian CTAs, and EU CTR from RIM to Clinical Vaults when the connection runs. In order to enable this feature, the relevant integration and integration points must be activated on RIM and Clinical Vaults. Each Inbound Integration Point and Integration Rule on Clinical corresponds to a specific milestone type. When the Inbound Integration Point is activated, the corresponding milestone type is updated based on values populated in the source RIM Vault. | Inbound Integration Point | Milestone Type | | :---- | :---- | | RIM-Clinical: Clinical Trial Submission | HA Application | | RIM-Clinical: Clinical Trial Approval | HA Approval | | RIM-Clinical: EU CTR Part I | EU CTR Part I Application | | RIM-Clinical: EU CTR Part II | EU CTR Part II Application | | RIM-Clinical: EU CTR Final Approval | Final Country Approval | When a Regulatory Objective is created or updated in RIM under an application that is related to clinical trial approval, the Connection is triggered and the corresponding Study or Study Country milestone's Link field is populated with the relevant Country Decision Detail Global ID. ### Required RIM Configuration * Ensure the RIM Submissions application is enabled. * Activate the _EU CTR Part_ field on the _Regulatory Objective_ object and add it to the _Regulatory Objective_ object type. Ensure standard picklist values are being used. * Activate the _EU CTR Part_ field on the _Submission_ object and add it to the _Investigational Drug Submission_ object type. Ensure standard picklist values are being used. * Add the *Approved*, _Approved with Conditions_, and _Rejected_ State Types to the _Country Decision Detail_ object lifecycle. Assign the appropriate lifecycle states to each State Type. ### Required Clinical Operations Configuration * Ensure the Study Startup (SSU) application is enabled. * Set the _Last Successful Run_ field of the RIM-Clinical: Submission Tracking Integration to the Date and Time of when you wish to start syncing records. For example, if the field is set to 01 Jul 2025, then when the Connection runs, it will update milestones based on all changes in RIM since 01 Jul 2025. It is recommended that this field is set to the day the integration is activated and not to a date in the past, else fields already set in Clinical may be overridden. * Add the _Submission Decision_ field on the _Milestone_ object to the _Standard Milestone_ Object Type * Navigate to **Admin > Connections > Clinical to RIM Connection > Reference Lookups** and open the `submission_decision__v` record. Create reference lookup records to map the RIM custom _Country Decision Detail_ lifecycle states to the appropriate picklist values of the _Submission Decision_ picklist. For example, the lifecycle state `approved__c` should map to the picklist value `approved__v`. * Navigate to **Admin > Connections > Clinical to RIM Connection > Reference Lookups** and open the `country__v` record. Review the mappings. The Source Key must be the RIM UUID. * If the Application Setting **Automate Milestone State Changes** is enabled, then review the Entry Criteria configured on the _Planned_ and _Complete_ states of the _Milestone_ object lifecycle. Any fields that must be populated but are not transferred via the Connection will need to be reviewed. When **Automate Milestone State Changes** is enabled and the Connection populates the _Planned Finish Date_ or _Actual Finish Date_ on the milestone, the milestone will attempt to move to the Planned or Complete state. If the milestone fails to validate all Entry Criteria, the Connection will fail. ## Connection Limitations Vault does not support any query object rules containing `IN` filter clauses when the _RIM to Clinops Connection: Transfer steady and superseded state document versions_ setting is enabled. See Standard Connection Limitations for additional limitations. ## Related Permissions You need a _System Admin_ security profile as well as the following permissions to set up the standard RIM-Clinical Operations Connection: | Type | Permission Label | Controls | |------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Security Profile | Admin: Application: Manage Connections | Ability to set up the RIM-Clinical Operations Connection | | Security Profile | Object: User Exception Item, User Exception Message: Read | Ability to see User Exception Item and User Exception Message records if a connection failure occurs | [8]: #reference-lookups [10]: #updating-fields [11]: #creation [12]: #document-type-groups [13]: #state-types [14]: #crosslinks [15]: #version-transfer [17]: #integration-rules [18]: #transferring-regulatory-tracking