Organizations using both a Clinical Operations Vault and a Quality Vault can utilize a connection between the two Vaults to automatically transfer Study data from Clinical Operations to Quality. This connection transfers Study, Study Country, and Study Site information across Vaults.
In addition, you can configure the connection to allow users to send an Issue to the QMS application in a customer’s Quality Vault. Upon receipt, QMS creates a GCP Deviation record, automatically populated with Study information, which the appropriate personnel can begin to process.
Note: The Quality to Clinical Operations Vault Connection is only available for organizations with both a Clinical Operations Vault and Quality Vault. Issue management functionality is only available for organizations with the Vault QMS application.
Configuration Overview
Perform the following steps to configure your Vaults to use the Quality to Clinical Operations Connection:
- Review connection components and adjust as needed
- Update the configuration in your Clinical Operations Vault
- Update the configuration in your Quality Vault
- Activate the connection
Quality to Clinical Operations Connection Components
The following components support the standard Quality to Clinical Operations connection.
Connections
The following Connection records are available from Admin > Connections:
- Quality to ClinOps Connection (
quality_to_clinops_connection__v) is available in your Quality Vault - Quality to ClinOps Connection (
quality_to_clinops_connection__v) is available in your Clinical Operations Vault
The connection is not active by default. Once set up, you will 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 define what data the connection maps from one Vault to another.
The Quality to ClinOps Connection record includes the following default Integration records with standard Integration Point records in your Clinical Operations Vault:
- Quality Study Data Integration
- Study Outbound Integration Point
- Study Country Outbound Integration Point
- Study Site Outbound Integration Point
- Issue Management Integration
- Issue Management Outbound Integration Point
The Quality to ClinOps Connection record includes the following default Integration records with standard Integration Point records in your Quality Vault:
- Study Data Integration
- Study Inbound Integration Point
- Study Country Inbound Integration Point
- Study Site Inbound Integration Point
- Issue Management Integration
- Issue Management Inbound Integration Point
Integration & Query Object Rules
To support the Quality 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 Integration Rules to incorporate configurable rules for mapping object fields between two Vaults.
The connection also supports Query Object Rules within each integration rule, allowing you to configure criteria using Criteria VQL to determine which records in your Clinical Operations Vault are to be created in the Quality Vault. For example, you could configure a rule in the Quality Vault so that the integration checks for a Phase III value in a Study Phase field on the Study object before creating that Study in the Quality Vault.
The following table contains Query Object Rules that Veeva provides by default for the Quality to Clinical Operations Connection in your Quality Vault:
| Records to be Transferred | Integration Rule | Query Object Rule | Filter Clause |
|---|---|---|---|
| Studies | Quality ClinOps: Study | Active Studies | status__v = 'active__v' |
| Study Countries | Quality ClinOps: Study Country | Active Study Countries | status__v = 'active__v' AND study__vr.status__v = 'active__v' |
| Sites | Quality ClinOps: Study Site | Active Study Sites | status__v = 'active__v' AND study__vr.status__v = 'active__v' |
Queues
This feature includes two (2) standard message processing queues. You can access and manage these queues from Admin > Connections > Spark Queues.
In your Clinical Operations Vault, you have:
- Quality to ClinOps Outbound Queue (
quality_clin_op_outbound_queue__v)
In your Quality Vault, you have:
- Quality to ClinOps Inbound Queue (
quality_clin_op_inbound_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 Quality to Clinical Operations Connection. If the Quality side of the integration can’t process an incoming message, Vault creates a User Exception Message record to capture the failure.
If the Quality side of the integration can’t process an incoming message, Vault creates a User Exception Message record to capture the failure. When the connection job runs, Vault processes all User Exception Messages that are in the Active state, and inactivates previous ones. Any new errors result in new User Exception Messages in the Active state. Vault also creates individual User Exception Item records for each item that failed on the related Integration Point record in the Clinical Operations Vault. The User Exception Item’s Error Message field contains the reason for error.
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 Retry Transfer action to run the connection and resolve errors.
Setting Up Your Clinical Operations Vault for the Connection
Before activating the connection, you must complete the following steps in your Clinical Operations Vault to ensure proper functioning of the connection:
- Ensure that all applicable Country object records exist in the Clinical Operations Vault, and that their Code field is populated with the two-digit country code (ISO 3166-1).
- Ensure the Vault is not in Record Migration Mode.
- Optional: Configure the Send to Quality object record action on the Quality Issue object.
- Optional: Configure the Issue object page layout to include the Quality Issue Link field, which contains a hyperlink pointing to the corresponding GCP Deviation record, if any, in the Clinical Operations Vault.
Send to Quality Action
A record action in your Clinical Operations Vault allows users to send Quality Issue data to the Quality Vault. When this action executes, Vault creates a GCP Deviation record in the Quality Vault.
Setting Up Your Quality Vault for the Connection
You must complete the steps described in the sections below in your Study Training Vault to enable the connection:
- Ensure that all applicable Country object records exist in the Quality Vault, and that their Code field is populated with the two-digit country code (ISO 3166-1).
- On the User Exception Message object, add the Retry Transfer custom action. Add this action to the Active state in the User Exception Message Lifecycle.
- Optional: Update permission sets to remove Create permission for the following objects and for their related object fields for appropriate security profiles:
- Study
- Study Country
- Study Site
- Optional: Configure the GCP Deviation object type page layout to include the Clinical Issue Link field, which contains a hyperlink pointing to the originating Issue record in the Clinical Operations Vault.
Generating Global IDs
The Quality to Clinical Operations connection relies on Global IDs to populate the Link field in the target Vault. If a record was last updated before the 19R3 release, the Global ID field may not be populated. If a record is missing the Global ID, contact Veeva Support and request that they generate this value on the Study, Study Country, and Study Site objects in your Clinical Operations Vault. If you have Study, Study Country, and Study Sites in Quality, populate the Link field value with the Global ID from the source record.
Last Successful Run Field
On every inbound Integration record, the Last Successful Run field captures the date and time the integration last ran. Vault uses this date to query changes since the integration’s last successful run.
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 object records within the scope of that integration point.
Activating the Connection
Once all configuration steps are complete, activate the connection.
Connection Limitations
See Standard Connection Limitations for a list of limitations that impact your Quality to Clinical Operations connection.
Related Permissions
You need a System Admin security profile as well as the following permissions to set up the standard Quality to Clinical Operations connection:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Admin: Application: Manage Connections | Ability to set up the Quality to Clinical Operations standard 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 |
| Security Profile | Object: User Exception Message: Object Action Permissions: Retry Transfer: View, Execute | Ability to perform the Retry Transfer action on a User Exception Message record. |
| Security Profile | Object: Issue: Object Action Permissions: Send to Quality | Ability to perform the Send to Quality action on an Issue record in the Clinical Operations Vault. |