Organizations using both a RIM Submissions Vault and a Clinical Operations eTMF Vault can utilize the Spark messaging framework to create a standard Vault to Vault connection. This connection transfers Product Family, Clinical Study, and Site records across Vaults and automates the creation and updating of CrossLink documents. See About the RIM to Clinical Operations Vault Connection for detailed information about how the connection works.

RIM to Clinical Operations Vault Connection Components

The following components support the standard Vault to Vault RIM to 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 eTMF Vault
  • RIM to Clinical Connection (rim_to_clinical_connection__v) is available in your RIM Submissions Vault

Note that you’ll still need to establish the Vault to Vault connection before you can use it.

Integration & 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.

The RIM to Clinical Connection record includes the following default Integration records with standard Integration Point records in your Submissions Vault:

Integration Name

Integration Point Name(s)

Sent From

Sent To

Included Data

Product Family Integration

Product Family Outbound Integration Point

Submissions

eTMF

  • Name
  • Global ID

Clinical Study Integration

Clinical Study Inbound Integration Point

eTMF

Submissions

  • Clinical Study Number
  • Primary Product Family
  • Study Description
  • Study Type
  • Link

Product Family Clinical Study Integration

Product Family Clinical Study Inbound Integration Point

eTMF

Submissions

  • Clinical Study
  • Product Family
  • Link

Clinical Site Integration

Clinical Site Inbound Integration Point

eTMF

Submissions

  • Site
  • Study
  • Site Country
  • Link

Inbound Documents

Inbound Documents Integration Point

eTMF

Submissions

  • Clinical Study
  • Name
  • Title
  • Product Family
  • Description
  • Link
  • Version Link
  • Major Version
  • Minor Version

Outbound Documents

Outbound Documents Integration Point

Submissions

eTMF

  • Clinical Study
  • Name
  • Title
  • Global ID
  • Global Version ID
  • Product Family
  • Description

The Clinical to RIM Connection record includes the following default Integration records with standard Integration Point records in your eTMF Vault:

Integration Name

Integration Point Name(s)

Sent From

Sent To

Included Data

Product Integration

Product Inbound Integration Point

Submissions

eTMF

  • Product Name
  • Link

Study Integration

Study Outbound Integration Point

eTMF

Submissions

  • Study Number
  • Product
  • Protocol Title
  • Study Type
  • Global ID

Study Site Integration

Study Site Inbound Integration Point

eTMF

Submissions

  • Study Site Number
  • Study Number
  • Study Country
  • Global ID

Inbound Documents

Inbound Documents Integration Point

Submissions

eTMF

  • Clinical Study
  • Name
  • Title
  • Global ID
  • Global Version ID
  • Product Family
  • Description

Outbound Documents

Outbound Documents Integration Point

eTMF

Submissions

  • Clinical Study
  • Name
  • Title
  • Product Family
  • Description
  • Link
  • Version Link
  • Major Version
  • Minor Version

Integration Rules

To support the RIM to 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 Spark Integration Rules to incorporate configurable rules for mapping object and document fields between two Vaults. Learn more about creating and managing Spark Integration Rules.

Queues

This feature includes four (4) standard message processing queues: two (2) in your Submissions Vault and two (2) in your eTMF Vault. You can access and manage these queues from Admin > Connections > Spark Queues.

In your eTMF 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 Submissions 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

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 to Clinical Operations Vault 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. If you want specific users or groups to receive notifications when Vault creates User Exception Message records, you must create a custom lifecycle for the User Exception Message object and configure a notification entry action.

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.

Standard Document Type Groups

The following Document Type Group records are available to support this connection:

  • Clinical to RIM Connection is available in your eTMF Vault
  • RIM to Clinical Connection is available in your Submissions Vault

Vault uses these document type groups to determine which document types to send 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. With additional configuration, Vault can also send superseded versions of documents that you have created since the last time the connection ran. Note that you must also configure a Document Type reference lookup 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

The following Document State Types are available to support this connection:

  • Inbound Transfer is available on document lifecycles in your eTMF Vault
  • Inbound is available on document lifecycles in your Submissions 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.

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 errors. Vault uses this date to query changes since the integration’s last successful run.

You can use the Last Successful Run field in the following ways:

  • 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.
  • If you need to rerun every Integration Point within the Integration record, you can clear the Last Successful Run field. The next time an action in either Vault triggers the connection, Vault will re-process all documents or object records within the scope of that integration point.

When activating a RIM to Clinical Operations Vault 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 to Clinical Operations Connection

You must complete the following steps in both your Submissions Vault and your eTMF 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 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 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 below.
  4. Ensure the connection’s standard Document Type Groups 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. In both Vaults, we recommend setting the connection’s document state types to the Approved state.
  6. Enable CrossLinks. See details about this step below.
  7. Optional: In the RIM Vault, navigate to Admin > Settings > Application Settings. Under the Submissions Features heading, set the RIM to Clinops Connection: Transfer steady and superseded state document versions to True.
  8. In Vaults created before 19R3, contact Veeva Support to request that they generate Global ID values for the Product Family object in your Submissions Vault and for the Clinical Study, Study Site, and Study Product objects in your eTMF Vault. The connection uses the Global ID field to transfer data across Vaults.
  9. We recommend that you create a flash report to run when there are active User Exception Message records in either Vault.
  10. Establish the Vault to Vault connection between your Submissions Vault and your eTMF Vault. See Creating & Managing Connections for detailed instructions.

If you don’t complete these steps in both Vaults, the connection will not work.

Configuring Reference Lookups

Reference lookups are a configuration component referenced by integration rules 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 RIM to Clinical Operations 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 reference lookups in your eTMF Vault. Load both Object reference lookups and Document Type reference lookups in your Submissions Vault. 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

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 Submissions Vault, update the Principal Investigator field on the Site object. Keeping Principal Investigator as a required field will cause errors 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 Submissions Vault, and on the Product object in your eTMF Vault. In addition, you must make the following updates in your Submissions 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.

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 RIM to Clinical Operations 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 Submissions Vault, update existing Clinical Study, Clinical Site, and Product Family Clinical Study records that have corresponding records in your eTMF Vault. In your eTMF Vault, update existing Product records.

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

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 Submissions and your eTMF 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 eTMF Vault but excluding them in your Submissions Vault.

Setting the RIM to Clinops Connection: Transfer steady and superseded state document versions

The RIM to Clinops Connection: Transfer steady and superseded state document versions setting tells Vault to include superseded documents when it runs the RIM to Clinical Operations connection. When set to True, Vault determines whether a superseded version of a document has been created since the last time the job ran. If one or more exists, Vault sends those documents through the connection, along with the Steady state document.

When set to False, Vault does not attempt to identify or transfer any document version except for the most recent Steady state version.

To set the RIM to Clinops Connection: Transfer steady and superseded state document versions setting, navigate to Admin > Settings > Application Settings in your RIM Vault. The setting is located under the Submission Features heading.

Connection Limitations

See Standard Vault to Vault Connection Limitations for a list of limitations that impact your RIM to Clinical Operations connection.

You need a System Admin security profile as well as the following permissions to set up the standard RIM to Clinical Operations connection:

Type

Permission Label

Controls

Security Profile

Admin: Application: Manage Connections

Ability to set up the RIM to 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