The ePRO/Clinical Operations Vault Connection transfers Study, Study Country, and Study Site records from your Clinical Operations Vault to your ePRO Vault in near-real time. Streamlining object records reduces duplicate data entry and allows your organization to have a single source of truth for this data.
Configuration Overview
You must complete the following steps in your Clinical Operations and ePRO Vaults to configure the standard connection:
- Clinical Operations Vault
- ePRO Vault
- If applicable, configure reference lookups in ePRO Vault for custom Clinical Operations lifecycle states.
- Establish the Vault to Vault connection between your ePRO Vault and your Clinical Operations Vault. See Creating & Managing Connections for detailed instructions.
You must complete these steps in both Vaults in order for the connection to work.
ePRO/Clinical Operations Vault Connection Components
The components in the following sections support the standard ePRO/Clinical Operations Vault Connection.
Connections
Note: Only one (1) Clinical Operations Vault can be connected to an ePRO Vault. You cannot create additional connections with multiple Clinical Operations Vaults.
The following Connection records are delivered as standard in Admin > Connections:
- ePRO/Clinical Operations Connection (
epro_clinops_connection__v) is available in your ePRO Vault. - ePRO/Clinical Operations Connection (
epro_clinops_connection__v) is available in your Clinical Operations Vault.
You must establish the Vault to Vault connection before you can use it.
Integrations & 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 (1) Vault to another. These records are read-only and are used by Vault to manage the connection and track any connection errors.
ePRO Vaults
The ePRO/Clinical Operations Vault Connection record includes the following default Integration records with standard Integration Point records in your ePRO Vault:
| Integration Name | Integration Point Name(s) | Sent From | Sent To | Included Data |
|---|---|---|---|---|
| Study Data | Study Transfer | Clinical Operations | ePRO | Study |
| Study Data | Study Country Transfer | Clinical Operations | ePRO | Study Country |
| Study Data | Study Site Transfer | Clinical Operations | ePRO | Study Site |
Clinical Operations Vaults
The ePRO/Clinical Operations Vault 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 |
|---|---|---|---|---|
| Study Data | Study Transfer | Clinical Operations | ePRO | Study |
| Study Data | Study Country Transfer | Clinical Operations | ePRO | Study Country |
| Study Data | Study Site Transfer | Clinical Operations | ePRO | Study Site |
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 ePRO/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.
System Admins can view and manage these messages from Admin > Connections > User Exception Messages.
A User Exception Message typically means that you need to update your source data in Clinical Operations due to missing fields or incorrect data setup. After you update the configuration, Vault attempts to resolve any errors the next time the connection runs. You can also select the Reprocess Request action to run the connection and resolve errors.
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, set this field to the date and time you will activate the connection. Only records created or updated after that date and time will be transferred.
- 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 re-processes all documents or object records within the scope of that integration point.
Updating Object Layouts
For the ePRO/Clinical Operations Vault Connection to work properly, you must add the following fields to the following object layouts in your Clinical Operations Vault:
- Add the Connect to Vault ePRO field to the Study (
study__v) object layout. - Recommended: add the Site Timezone field to the Study Site (
study_site__v) object layout.
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 indirectly from a value in the source Vault. When you configure the ePRO/Clinical Operations Vault Connection, you need to add reference lookups for any custom lifecycle states.
For example, for Vault to transfer a study with a custom Clinical Operations lifecycle state to ePRO Vault, you need to create ClinOps Lifecycle Status (clinops_lifecycle_status__v) reference lookups to map the source lifecycle state to the target lifecycle state label. See Creating & Managing Reference Lookups for detailed instructions.
In ePRO Vault, you need to create reference lookups for any of the items below that exist in the Clinical Operations Vault. Custom lifecycle states can be identified with a __c ending.
- Custom Study lifecycle states
- Custom Study Country lifecycle states
- Custom Study Site lifecycle states
Verifying the Country Code in Clinical Operations
To transfer a Study Country from Clinical Operations to ePRO, the connection requires that the Code field be populated for Country records in Clinical Operations. Older vaults may not have this populated.
You need to verify that Country records in Clinical Operations all have a value in the Code column. You can access Country records by navigating to Business Admin > Objects > Countries.
If Country Code values are missing, contact Veeva Services for help.
Updating Field Requiredness
Clinical Operations should be the source of truth for Studies, Study Countries, and Study Sites. We recommend making the Site Timezone (site_timezone__v) field required on Study Site in Clinical Operations to ensure that Clinical Operations is the source of truth. Use the Required Setting on the field to make it required.
Connecting Existing Records
When you configure the ePRO/Clinical Operations Vault Connection, you may have study and other records that were manually created in both Vaults. If you want to connect the existing records across Clinical Operations and ePRO, Vault does not automatically match them. You can, however, link the two (2) records manually using the steps below. If you fail to do so, running the ePRO/Clinical Operations Connection may result in errors or duplicate records.
- From your Clinical Operations Vault, copy the Global ID and note the Study Number of the first Study you wish to link.
- From your ePRO Vault, locate the Study you want to link based on the Study Number from Clinical Operations.
- Enter the Global ID from your Clinical Operations Vault in the Link field of the study in your ePRO Vault.
Repeat these steps for any Study Country and Study Site records that were manually created for that study in both Vaults. Then you can set the records to be transferred moving forward using the Connect to Vault ePRO field on the Study in Clinical Operations.