Configuring the Study Training to Clinical Operations Vault Connection

Organizations using both a Clinical Operations Vault and a Study Training Vault can utilize the Study Training to Clinical Operations Connection to automatically transfer data and documents from Clinical Operations to Study Training. This connection transfers Study, Study Country, Study Site, Study Person, Person, Organization, and domain User information across Vaults and automates CrossLink document creation and up-versioning.

Note: The Study Training to Clinical Operations Vault Connection is only available for organizations with both a Clinical Operations Vault and Study Training Vault.

Configuration Overview

Perform the following steps to configure your Vaults to use the Study Training to Clinical Operations Connection:

Set up connection components
Update the configuration in your Clinical Operations Vault
Update the configuration in your Study Training Vault
Activate the connection

Study Training to Clinical Operations Vault Connection Components

The following components support the standard Vault to Vault Study Training to Clinical Operations connection.

Connections

The following Connection records are available from Admin > Connections:

Study Training to Clinical Operations Connection (study_training_to_clinops_connection__v) is available in your Study Training Vault
Study Training to Clinical Operations Connection (study_training_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 documents and data the connection maps from one Vault to another.

The Study Training to Clinical Operations Connection record includes the following default Integration records with standard Integration Point records in your Clinical Operations Vault:

Study Data Integration
- Study Outbound Integration Point
- Study Country Outbound Integration Point
- Study Site Outbound Integration Point
Study Persons Integration
- Responsibility Outbound Integration Point
- Study Person Outbound Integration Point
- Study Person Responsibility Integration Point
Study Training Materials Integration
- Study Training Materials Outbound Integration Point

The Study Training to Clinical Operations Connection record includes the following default Integration records with standard Integration Point records in your Study Training Vault:

Study Data Integration
- Country Inbound Integration Point
- Organization Inbound Integration Point
- Study Country Inbound Integration Point
- Study Inbound Integration Point
- Study Site Inbound Integration Point
Study Persons Integration
- Person Inbound Integration Point
- Responsibility Inbound Integration Point
- Study Person Inbound Integration Point
- Study Person Responsibility Inbound Integration Point
Study Training Materials Integration
- Study Training Materials Inbound Integration Point

Integration & Query Object Rules

To support the Study Training 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 and document fields between two Vaults.

The connection also supports Query Object Rules for its integrations, allowing you to configure criteria using Criteria VQL to determine which records or documents in your Clinical Operations Vault are to be created in the Study Training Vault. For example, you could configure a rule in the Study Training 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 Study Training Vault.

The following table contains useful Query Object Rules to define for the Study Training to Clinical Operations Connection in your Study Training Vault:

Object	Criteria VQL	Description
Study Person	`status__v = 'active__v' AND study__clinr.connect_to_vault_study_training__v = true`	Includes Study Persons that are active and the Study’s Connected to Study Training value is Yes
Study Person	`status__v = 'active__v' AND study__clinr.connect_to_vault_study_training__v = true AND site__clin = null`	Includes Study Persons that are active, the Study’s Connected to Study Training value is Yes, and that do not have an assigned Site
Person	`vault_user__sys !=null`	Includes Persons that are associated with a system User record.
Study	`status__v = 'active__v' AND connect_to_vault_study_training__v = true`	Includes Studies that are active and the Study’s Connected to Study Training value is Yes
Study Country	`status__v = 'active__v' AND study__vr.connect_to_vault_study_training__v = true`	Includes Study Countries that are active and the Study’s Connected to Study Training value is Yes
Site	`status__v = 'active__v' AND study__vr.connect_to_vault_study_training__v = true`	Includes Sites that are active and the Study’s Connected to Study Training value is Yes
Documents	`connect_to_vault_study_training__v = true AND crosslink__v = false`	Includes Vault documents which are not CrossLinks but have a Connected to Study Training value of Yes. In addition, only documents that are Steady State are candidates for transfer to Study Training

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:

Study Training to ClinOps Outbound Queue (study_training_clin_op_outbound_queue__v)

In your Study Training Vault, you have:

Study Training to ClinOps Inbound Queue (study_training_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 Study Training to Clinical Operations Vault Connection. If the Study Training 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.

Configuring 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:

Activate the Connect to Vault Study Training shared document field and add it to any document types. Documents with Connect to Study Training = Yes will be transferred to Study Training.
Activate and add the Connect to Study Training Vault field on the Study object page layout.
Configure the Code field on the Country object to use the User must always enter a value (required) and Values must be unique options. If any Country record lacks the value, populate it with the appropriate two-digit country code.
Export record data for the following object records from the Clinical Operations Vault: Person, Country, and Organization. Include the Global ID field. Import the records into the Study Training Vault and map Global ID (Clinical Operations) to Link (Study Training). This ensures Person, Country, and Organization references on Study Person, Study Country, and Study Site are available. This export/import process is only required once.

Configuring Your Study Training Vault for the Connection

You must complete the steps described in the sections below in your Study Training Vault to enable the connection:

Study Training Object & Document Configuration

Before activating the connection, you must complete the following steps in your Study Training Vault to ensure the connection functions properly:

Add Global ID or Code values to the Link or Document Link field on any existing records in Study Training of the below objects and documents. The Global ID values should correspond to like records in the Clinical Operations Vault. Failure to populate these values may result in Vault creating duplicate records:
- Study (Fields: Global ID, Link)
- Study Country (Fields: Global ID, Link)
- Study Site (Fields: Global ID, Link)
- Study Person (Fields: Global ID, Link)
- Country (Fields: Global ID, Link)
- Organization (Fields: Global ID, Link)
- Person (Fields: Global ID, Link)
Populate the Document Link and Document Version Link data in existing documents, and set version binding to Specific Document Version. Ensure that these fields are populated appropriately for any existing CrossLinks.
Configure any Study object reference fields on documents to use the Allow user to select multiple values option.
Activate the standard Training Materials document type and associate the recommended Draft to Approved document lifecycle. On the Training Materials document lifecycle:
- Configure the following entry actions on the state selected as the Steady State:
  - Set new major version
  - Set previous steady state to superseded
  - Create Training Requirement Impact Assessment Record
- Configure the Cancel Open Training Assignments entry action on the state selected as the Superseded State.
- Configure the Retire or Assess Impact on Training Requirements entry action on the state selected as the Obsolete State.
Review your Vault’s study_team_role__v object configuration. Depending on when your Vault was created, this object may be labeled “Clinical Mapping”, “Study Team Role”, or “Clinical Study Team Role”. To configure the object for the connection:
- Ensure the Object Label and Object Plural Label are Clinical Mapping and Clinical Mappings, respectively.
- Add the following to the object page layout:
  - Source Key Field Selector control
  - Training Type and Role Type fields
- Within any impacted permission sets, ensure users working with Clinical Mapping records are granted Read, Create, and Edit access to the object, as well as View access to the object’s Source Key Field Selector object control.
On the Organization, Person, and LearnerRole-Person objects, configure the Link field to use the Values must be unique and Do not copy this field in Copy Record options.
Configure the Code field Country to use the User must always enter a value (required) and Values must be unique options. If any Country record lacks the value, populate it with the appropriate code.
Add the appropriate View In Clinical formula field on the following objects’ page layout, and update the field’s formula on existing records with the record ID field value:
- Study (Field: Clinical Study Link)
- Study Country (Field: Clinical Study Country Link)
- Study Site (Field: Clinical Study Site Link)
- Study Person (Field: Clinical Study Person Link)
- Country
- Organization
- Person
Since Person data comes from the Clinical Operations Vault, configure the Person object’s fields to non-required, and remove any Training Eligibility default value configurations.
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: Activate the External Site object type on Organization object and make it the default object type.
Optional: Update permission sets to remove Create permission for the following objects and for their related object document fields for appropriate security profiles:
- Study
- Study Country
- Study Site
- Study Person

Study Training User Management

Study Training offers multiple methods for managing User and Person records. The methods described here can be configured together or separately, depending on your organization’s requirements.

Enabling VeevaID

VeevaID is a Vault application identity provider which allows users to access Vaults on multiple sponsor domains with a single user ID and password. In Study Training, a Vault Admin can send Learners an invitation to register for VeevaID (individually or in bulk), or the process can be automated via the connection.

See VeevaID for Study Training for further details.

Auto-Creating Domain Users

By default, when a Study Manager creates a Clinical Operations Person record, the connection automatically creates a corresponding Person record in Study Training. Then, a Study Training Vault Admin creates the person’s domain User record and manually associates it with the new Person record.

When enabled, the Auto Manage Persons setting and related job can replace the Vault Admin’s manual steps by automatically:

Creating a domain User record in Study Training with the same details as those in Clinical Operations, when in Clinical Operations the Person record with a referenced User is associated with at least one Study.
Updating existing Study Training Person records with the appropriate User reference and Training Eligibility value.

To enable the connection to automatically create domain Users, confirm the Clinical to Study Training User Management job is active and scheduled to run according to your organization’s requirements.

If your Study Training Vault uses Role Dependencies, Vault also creates and assigns users the appropriate User Role Setup record. See Creating Role Dependency Records for further details.

Enabling 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 Clinical Operations and your Study Training Vaults, you’ll need to enable CrossLinks in your Study Training Vault. Vault will not sync documents from the Clinical Operations Vault which lack an associated Study.

Clinical Mappings & Reference Lookups

Prior to 24R2, the connection’s integration rules relied upon reference lookups to map Study Team Roles (or “Clinical Study Team Roles”) to Study Learner Roles.

As of 24R2 and the introduction of responsibility-based training, these reference lookups are no longer required. Instead:

Roles mapped in any existing lookups at the time of the 24R2 release are automatically available in all production Vaults as Clinical Mapping (study_team_role__v) records. When creating records during the upgrade, Vault also:
- Inactivated the existing lookups, as they are no longer in use.
- Set mapping records’ Training Type field to “Role”, but did not set the Role Type field. You can populate this field to delineate mappings for the Project Team or Site Staff, or it can remain null. When null, Vault assumes the record is for a Project Team member. This reflects system behavior prior to the upgrade.
A set of standard responsibilities are automatically available in all existing and new Study Training Vaults as Clinical Mapping records with their Training Type field set to “Responsibility”.

For any new role mappings, you’ll create and map them using the Clinical Mapping object.

For any new responsibility mappings, the connection automatically manages additional them in Study Training using the Study Person Responsibility records your organization creates in Clinical Operations. You cannot manually create Clinical Mappings for responsibilities in your Study Training Vault.

Generating Global IDs

The Study Training 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, Study Site, and Study Person objects in your Clinical Operations Vault. If you have Study, Study Country, Study Site, and Study Person records in Study Training, 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.

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.

Activating the Connection

Once all configuration steps are complete, activate the connection.

Connection Limitations

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

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

Type	Permission Label	Controls
Security Profile	Admin: Application: Manage Connections	Ability to set up the Study Training 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.