The eCOA-Clinical Operations Connection transfers Study, Study Country, and Study Site records from your Clinical Operations Vault to your eCOA 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 eCOA Vaults to configure the standard connection:
- Clinical Operations Vault
- eCOA Vault
- Establish the Vault to Vault connection between your eCOA 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.
eCOA-Clinical Operations Connection Components
The components in the following sections support the standard eCOA-Clinical Operations Connection.
Connections
Note: Only one Clinical Operations Vault can be connected to an eCOA Vault. You cannot create additional connections with multiple Clinical Operations Vaults.
The following Connection records are delivered as standard in Admin > Connections:
- Clinical Operations-eCOA Connection (
epro_clinops_connection__v) is available in your eCOA Vault. - Clinical Operations-eCOA 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 Vault to another. These records are read-only and are used by Vault to manage the connection and track any connection errors.
The connection record in both the eCOA and Clinical Operations Vaults include the following default Integration records with standard Integration Point records:
| Integration Name | Integration Point Name(s) | Sent From | Sent To | Included Data |
|---|---|---|---|---|
| Study Data | Study Transfer | Clinical Operations | eCOA | Study |
| Study Data | Study Country Transfer | Clinical Operations | eCOA | Study Country |
| Study Data | Study Site Transfer | Clinical Operations | eCOA | Study Site |
| eCOA End-of-Study Media | eCOA Participant Files | eCOA | Clinical Operations | Documents |
| eCOA Study Design Specification | eCOA Study Design Specification | eCOA | Clinical Operations | Documents |
Configuring End-of-Study Media Integration
When enabled, the eCOA End-of-Study Media integration for the eCOA - Clinical Operations connection automates the creation of eCOA end-of-study participant reports as CrossLinks in the Clinical Operations Vault. CrossLinks are created with the classification and lifecycle configured in Clinical Operations Vault.
Before you enable the eCOA End-of-Study Media integration, your Vault must have Study, Study Country, and Study Sites records linked between eCOA and Clinical Operations Vaults.
Enabling the End-of-Study Media Integration
The eCOA End-of-Study Media integration is Inactive by default. An Admin must enable the eCOA End-of-Study Media integration in the Clinical Operations Vaults.
To enable the eCOA End-of-Study Media integration for eCOA Vaults:
- Navigate to Admin > Connections > Clinical Operations-eCOA Connection.
- In the Integrations section, locate the eCOA End-of-Study integration and click Edit.
- Update the Status field to Active.
- Click Save.
To enable the eCOA End-of-Study Media integration for Clinical Operations Vaults:
- Navigate to Admin > Connections > Clinical Operations-eCOA Connection.
- In the Integrations section, locate the eCOA End-of-Study Media integration.
- From the Actions menu for the eCOA End-of-Study Media integration, select Activate.
When you enable the eCOA End-of-Study Media integration in your Vaults, end-of-study media transfer is enabled for all connected Studies.
Configuring the Document Type for End-of-Study Media
Once you enable the integration, an Admin must configure the Document Type for eCOA End-of-Study Media setting in the Clinical Operations Vault.
To configure the Document Type for eCOA End-of-Study Media setting:
- Navigate to Admin > Settings > Application Settings and click Edit.
- In the eTMF Features section, select the Document Type for eCOA End-of-Study Media checkbox.
- Select a Document Type from the drop-down. The Document Type must be a document Classification.
- Select a Lifecycle from the drop-down. The lifecycle you select must have a steady state defined.
- Click Save.
Triggering End-of-Study Media Integration
The generation and re-generation of eCOA end-of-study media triggers the creation and updates of CrossLinks in Clinical Operations. When the eCOA Vault regenerates the end-of-study media packages, the eCOA-Clinical Operations connection updates the target End-of-Study Media documents in the Clinical Operations Vault. The connection creates the target End-of-Study Media documents in the selected classification and lifecycle’s steady state.
End-of-Study Media documents in the Clinical Operations vault labels Restricted end-of-study media packages from eCOA Vaults as Unblinded. The connection also populates the Name, Study, Study Country, and Study Site fields with the data from the source document. If the connection cannot populate any of these fields, Vault creates a User Exception and does not create the target document.
When an error occurs while processing an end-of-study media record, the connection creates a User Exception and retries the file on the next connection run.
Configuring the Study Design Specification Integration
eCOA Vaults generate Study Design Specification (SDS) documents when study collections are approved as a comprehensive representation of the study build. When enabled, the eCOA Study Design Specification integration enables the eCOA - Clinical Operations connection to automate the creation of eCOA SDS documents as CrossLinks in Clinical Operations Vaults. Before you enable the eCOA Study Design Specification integration, your Vault must have Study records linked between eCOA and Clinical Operations Vaults.
Enabling the Study Design Specification Integration
The eCOA Study Design Specification integration is Inactive by default. An Admin must enable the integration in the Clinical Operations Vaults. To enable the eCOA End-of-Study Media integration for eCOA Vaults:
- Navigate to Admin > Connections > Clinical Operations-eCOA Connection.
- In the Integrations section, locate the eCOA Study Design Specification integration and click Edit.
- Update the Status field to Active.
- Click Save.
To enable the integration:
- Navigate to Admin > Connections > Clinical Operations-eCOA Connection.
- In the Integrations section, locate the eCOA Study Design Specification integration.
- From the Actions menu for the eCOA Study Design Specification integration, select Activate.
You must enable the integration on both Vaults. When you enable the eCOA Study Design Specification integration in your Vault, eCOA SDS document transfer is enabled for all connected Studies.
Configuring the Document Type for Study Design Specification
Once you enable the integration, an Admin must configure the Document Type for eCOA Study Design Specification setting in the Clinical Operations Vault.To configure the Document Type for eCOA Study Design Specification setting:
- Navigate to Admin > Settings > Application Settings and click Edit.
- In the eTMF Features section, select the Document Type for eCOA Study Design Specification checkbox.
- Select a Document Type from the drop-down. The Document Type must be a document Classification.
- Select a Lifecycle from the drop-down. The lifecycle you select must have a steady state defined.
- Click Save.
Triggering Study Design Specification Integration
When users approve a study collection in the eCOA Vault, the connection triggers the transfer of the new or up-versioned Study Design Specification (SDS) documents to the Clinical Operations Vault. When the connection runs for the eCOA Study Design Specification integration, the Clinical Operations queries eCOA for all new and updated Study Design Specification documents for connected Studies that have been updated since the last connection run. The connection creates the target Study Design Specification documents in the selected lifecycle’s steady state. When an error occurs while processing an SDS record, the connection creates a User Exception and retries the file on the next connection run.
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 eCOA-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.
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 eCOA-Clinical Operations 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 eCOA field to the Study (
study__v) object layout. - Recommended: add the Site Timezone field to the Study Site (
study_site__v) object layout and make required.
Verifying the Country Code in Clinical Operations
To transfer a Study Country from Clinical Operations to eCOA, 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 eCOA-Clinical Operations 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 eCOA, Vault does not automatically match them. You can, however, link the two records manually using the steps below before setting Connect to Vault eCOA to Yes on the Study in Clinical Operations. If you fail to do so, running the 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 eCOA 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 eCOA 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 eCOA field on the Study in Clinical Operations.