Configuring the Safety to Clinical Operations Vault Connection

Using the Safety to Clinical Operations Vault Connection, organizations with both a Clinical Operations Vault and a Safety Vault can exchange data in near-real time. To use the Safety to Clinical Operations Vault Connection, you must configure the relevant components, connect any existing data, and activate the connection. This setup requires configuration steps in both Vaults.

Connections

The following Connection records are available from Admin > Connections:

Safety to Clinical Connection (safety_to_clinical_connection__v) is available in your Safety Vault
Safety to Clinical Connection (safety_to_clinical_connection__v) is available in your Clinical Operations Vault

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

Integration and 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 Safety to Clinical Operations Vault Connection record includes the following default Integration records with standard Integration Point records in your Safety Vault:

Integration Name

Integration Point Name(s)

Sent From

Sent To

Included Data

Clinical Study Integration

Study Integration Point

Clinical Operations

Safety

Global ID
Clinical Operations Study State
Masking
Study Name
Study Number
Study Phase
Study Type
Study Start Date
Protocol Title

Note: Organization is set on the Safety Vault for which the Study will be associated with.

Clinical Study Integration

Study Country Integration Point

Clinical Operations

Safety

Global ID
Country
Clinical Operations
Study Country State
Study Global ID

Integration Rules

To support the Safety to Clinical Operations Vault 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.

Queues

This feature includes two (2) standard message processing queues queues: one (1) on the Safety Vault and one (1) on the Clinical Operations Vault. You can access and manage these queues from Admin > Connections > Spark Queues.

In the Safety Vault:

Safety to Clinical Inbound Queue (safety_clinical_inbound_queue__v)

In the Clinical Operations Vault:

Safety to Clinical Outbound Queue (safety_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 Safety 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 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 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 re-processes all documents or object records within the scope of that integration point.

When activating a Safety 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 Steps

You must complete the following steps in both your Safety Vault and Clinical Operations Vault to configure the standard connection:

Migrate Clinical Operations Study data from custom fields to standard fileds and inactivate the custom fields.
Update Page layouts.
Configure reference lookups for controlled fields within the integration scope and load these to each Vault.
Update any required fields that are not defined in the connection to either have a default value or to make values not required.
Update object lifecycles to assign initial objects’ states.
We recommend that you create a flash report User Exception Message records in the Safety Vault.
Establish the Vault to Vault connection between your Safety 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.

Clinical Operations Data Migration

In order to use the Safety to Clinical Operations Vault Connection, you must ensure that the studies in your Clinical Operations Vault include the standard Masking (masking__v), Study Name (study_name__v), and Study Start Date (study_start_date__v) fields and not the previously-used custom Masking (masking__c), Study Name (study_name__c), and Study Start Date (study_start_date__c) fields. For any existing studies that use the custom fields, you must migrate the data from the custom fields to the standard fields. You can accomplish this using Vault Loader.

Use Vault Loader to extract the Study object metadata from your Clinical Operations Vault.
Open the resulting CSV file in an editor.
Locate the three custom fields in the file (masking__c, study_name__c, and study_start_date__c).
Copy the data from these columns into the columns for the standard fields (masking__v, study_name__v, and study_start_date__v).
Save the CSV file.
Use Vault Loader to update the Study object records in your Clinical Operations Vault. Ensure that you select Study Number (name__v) from the Key Field drop-down.

Note: When copying the data from the custom fields into the standard fields, ensure that the date is in the following format: YYY-MM-DD. Some editors may change the date format.

Inactivate Fields

Once you have migrated the data to the standard fields (masking__v, study_name__v, study_start_date__v), you must inactivate the custom fields (masking__c, study_name__c, study_start_date__c):

From Admin > Configuration > Objects, click the Study object.
Open the Fields tab.
Click the first custom field you wish to mark as Inactive.
Click Edit.
From the Status drop-down, select Inactive.

Repeat for the additional custom fields you need to mark as Inactive.

You should only need to perform the data migration and field inactivation procedures once, when you are first setting up the Safety to Clinical Operations Vault Connection.

Update Page Layouts

In order for the Safety to Clinical Operations Vault Connection to work properly, you must add the following fields to the following page layouts.

In your Safety Vault:

Add the ClinOps State and Protocol Title fields to the Study (study__v) page layout
Add the ClinOps State field to the Study Registration (study_registration__v) page layout

In your Clinical Operations Vault:

Remove the inactive Masking (masking__c), Study Name (study_name__c), and Study Start Date (study_start_date__c) fields from the Study (study__v) page layout
Add the standard Masking (masking__v), Study Name (study_name__v), and Study Start Date (study_start_date__v) fields to the Study (study__v) page 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 Safety to Clinical Operations Vault 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 studies from one Vault to the other, you need to create Study Type reference lookups to map the source study types to the target study types. See Creating & Managing SDK Reference Lookups for detailed instructions.

You need to create reference lookups in your Safety Vault for the following:

Study Type
Development Phase

As a part of the connection offering, the country__v and masking__v reference lookups are already configured. It is critical for the implementation to review these mappings to ensure that they are correct. You can view the reference lookups by navigating to Admin > Connections > Safety to Clinical Connection > Reference Lookups in your Safety Vault.

Note: In the Safety Vault, the United Kingdom is represented by two separate values: United Kingdom (Great Britain) and United Kingdom (Northern Ireland). In the Clinical Operations Vault, there is only one value: United Kingdom. Because of this, the United Kingdom (Northern Ireland) value is not mapped directly. You can change this if required.

Loading Mappings

Once you have created CSV mapping files for Study records, you can use Vault Loader to load reference lookups to your Vault. Once you load the reference lookups, confirm that they loaded successfully. Then, navigate to Admin > Connections in your Safety and Clinical Operations Vaults and review the reference lookups to ensure they appear as expected.

Updating Fields & Rules

In order for the connection to run successfully, you need to update any required 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 Safety Vault, review and make any update necessary for the default value for the Organization (safety_study_organization__v), Study Type (safety_study_type__v), Masking (safety_study_masking__v), and Study Phase (safety_study_phase__v) fields default values.

Required Fields

In the Clinical Operations Vault, Study Name (study_name__v) is not required. This is a required field in the Safety Vault, however. If the connection attempts to send a record from the Clinical Operations Vault to the Safety Vault without this required field, it generates a User Exception Message and the transfer fails. To avoid this, you can create a Validation Rule that tells Vault to require the Study Name field in the Clinical Operations Vault.

Validation Rules

The Safety Vault has a custom validation rule for configuring the “Blinded” value if the Masking is set to “Double-Blind”. Because the Blinded field is not a field in the Clinical Operations Vault, the Safety to Clinical Operations Vault Connection does not populate this field. Before running the Safety to Clinical Operations Vault Connection, you should ensure that this validation rule is inactive in the Safety Vault. Once the Study record transfers through the connection, you can then set the Blinded field in the Safety Vault.

User Exception Message Configuration

Make the following changes to the User Exception Message object configuration in your Safety Vault:

Navigate to Admin > Configuration > Object > User Exception Message > Actions. Select the Reprocess Request action and click Save.
Update the User Exception Message object page layout to include a related object section for the User Exception Items. Select the radio button to Prevent record creation.

Additional Safety Vault Configuration

In addition to the steps described above, you must complete a few additional configuration steps in your Safety Vault:

Update the Study object lifecycle to set New as the initial state
Update the Study Registration object lifecycle to set New as the initial state

Connecting Existing Studies

When you start the Safety to Clinical Operations Vault Connection, you will likely have studies populated in both Vaults. Vault does not automatically match an existing Clinical Operations Study to an existing Safety Vault Study. You can, however, link the two Study records manually. If you fail to do so, running the Safety to Clinical Operations Connection may result in errors or duplicate Study records.

From your Clinical Operations Vault, export the Global ID and Study Number of the first Study you wish to link.
From your Safety Vault, locate the Study you wish to link.
Enter the Global ID from your Clinical Operations Vault into the Link field in your Safety Vault.

Repeat these steps to link additional Study records.