Configuring the Safety-Clinical Operations Connection

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

Configuration Overview

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

1. Review the connection components and adjust as needed to fit your organization’s business processes.
2. Migrate Clinical Operations Study data from custom fields to standard fields and inactivate the custom fields.
3. Update object layouts.
4. Configure reference lookups for controlled fields within the integration scope and load these to each Vault.
5. Update any required fields that are not defined in the connection to either have a default value or to make values not required.
6. Update object lifecycles to assign initial objects’ states.
7. Link existing Studies in your Safety and Clinical Operations Vaults.
8. Optional: Configure both Vaults to transfer Safety Letters from your Safety Vault to your Clinical Operations Vault.
9. We recommend creating a flash report to run when there are active User Exception Message records in your Safety Vault.
10. Establish the Vault to Vault connection between your Safety Vault and your Clinical Operations Vault. See Creating & Managing Connections for detailed instructions.

Safety-Clinical Operations Connection Components

The components in the following sections support the standard Safety-Clinical Operations Connection.

Connections

The following Connections are available from Admin > Connections:

• Safety to Clinical Connection (safety_to_clinical_connection__v) in your Safety Vault
• Safety to Clinical Connection (safety_to_clinical_connection__v) in your Clinical Operations Vault

You must establish the Vault to Vault connection before you can use it.

Integration & 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.

Safety Vaults

The Safety-Clinical Operations Connection includes the following default Integrations with standard Integration Points in your Safety Vault:

Integration	Integration Point	Sent From	Sent To	Included Data
Clinical Study Integration	Study Integration Point	Clinical Operations	Safety	Study (including the associated Organization)
Clinical Study Integration	Study Registration Int Point	Clinical Operations	Safety	Study Registration
Safety Distributions Integration	Safety Distribution Outbound Integration Point	Safety	Clinical Operations	Distribution (with CrossLinks)
Safety Distributions Integration	Safety Distribution Created Inbound Integration Point	Clinical Operations	Safety	Distribution
Safety Distributions Integration	Safety Distribution Distributed Inbound Integration Point	Clinical Operations	Safety	Distribution

Clinical Operations Vaults

The Safety-Clinical Operations Connection includes the following default Integrations with standard Integration Points in your Clinical Operations Vault:

Integration	Integration Point	Sent From	Sent To	Included Data
Clinical Study Integration	Study Integration Point	Clinical Operations	Safety	Study
Clinical Study Integration	Study Country Integration Point	Clinical Operations	Safety	Study Country
Safety Letter Integration	Vault Safety Inbound Document Creation	Safety	Clinical Operations	Safety Distribution (with CrossLinks)
Safety Distribution Integration	Safety Distribution Created	Clinical Operations	Safety	Safety Distribution

Integration Rules

To support the Safety-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 (2) Vaults.

CRO Support

By default, the Safety-Clinical Operations Vault Connection associates a single Organization with each Study generated in your Safety Vault. To support multiple sponsor Organizations for a Study, we recommend activating the safety_study_cro_organization__v field rule for the Study Integration Rule instead of using a custom integration rule. If you do this, you must also inactivate the safety_study_organization__v field rule.

Queues

The Safety-Clinical Operations Vault Connection includes the following message processing queues:

• Safety Vault:
  • Safety to Clinical Inbound Queue (safety_clinical_inbound_queue__v)
  • Safety to Clinical Inbound Queue Distribution (safety_clin_inbound_dist_queue__v)
• Clinical Operations Vault:
  • Safety to Clinical Outbound Queue (safety_clinical_outbound_queue__v)
  • Safety to Clinical Outbound Queue Distribution (safety_clin_outbound_dist_queue__v)

You can access and manage these queues from Admin > Connections > Spark Queues.

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-Clinical Operations Vault Connection. If either Vault is unable to process incoming data, Vault creates a User Exception Message to capture the failure and individual User Exception Items for each item that failed on the related Integration Point in the outbound Vault. The connection retries failed items from previous connection runs during the next run. Vault reprocesses integration points when the User Exception Item has a Last Run Time more recent than the Last Successful Run Time.

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 Messages, you must create a custom lifecycle for the User Exception Message object and configure a notification entry action.

Resolving 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 Reprocess Request action on a User Exception to run the connection and resolve errors.

Last Run Time (LRT) Field

On every inbound Integration, the Last Run Time field captures the date and time that the integration last ran. Vault uses this date with the Last Successful Run Time field to determine which integration points to retry during the next connection run.

Last Successful Run Time (LSRT) Field

On every inbound Integration, the Last Successful Run Time 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 Time field in the following ways:

• If you don’t want Vault to transfer existing object records, populate this field with the date and time you plan to activate the connection.
• If you need to rerun every Integration Point within the Integration, you can clear the Last Successful Run Time 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-Clinical Operations Connection, populate the Last Successful Run Time field on each active Integration to the date and time you want transfers to start. If you do not populate this field, Vault will transfer all relevant records and documents.

Clinical Operations Data Migration

In order to use the Safety-Clinical Operations Connection, you must ensure that the Studies in your Clinical Operations Vault include the Masking, Study Name, and Study Start Date standard (__v) fields rather than custom (__c) fields. You must migrate the data for any Studies using the custom fields and then inactivate the custom fields.

You should only need to perform the data migration and field inactivation procedures once when you first set up the Safety-Clinical Operations Connection.

Migrating Data

We recommend using Vault Loader to migrate data in your Clinical Operations Vault:

1. Use Vault Loader to extract the Study object metadata.
2. Open the resulting CSV file in an editor.
3. Locate the three (3) custom fields in the file (masking__c, study_name__c, and study_start_date__c).
4. Copy the data from these columns into the columns for the standard fields (masking__v, study_name__v, and study_start_date__v).
5. Save the CSV file.
6. Use Vault Loader to update the Studies.
   • Ensure that you select Study Number (name__v) from the Key Field drop-down.

Inactivating Fields

Once you have migrated the data to the standard fields, you must inactivate the custom fields:

1. Navigate to Admin > Configuration > Objects > Study > Fields.
2. Click the custom field you want to mark as Inactive.
3. Click Edit.
4. From the Status drop-down, select Inactive.
5. Repeat these steps for each of the following fields:
   • masking__c
   • study_name__c
   • study_start_date__c

Updating Object Layouts

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

In your Safety Vault:

• Add the ClinOps State and Protocol Title fields to the Study object layout
• Add the ClinOps State field to the Study Registration object layout

In your Clinical Operations Vault:

• Remove the inactive Masking, Study Name, and Study Start Date custom (__c) fields from the Study object layout
• Add the standard Masking, Study Name, and Study Start Date (__v) fields to the Study 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. 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.

You must add reference lookups for controlled fields within the integration scope. We recommend creating CSV mapping files and using Vault Loader to upload these to your Vault to create reference lookups. For example, in order for Vault to transfer studies from one (1) Vault to the other, you must 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 must create reference lookups in your Safety Vault for the following:

• Study Type
• Development Phase

To support Safety Letters, you must also create reference lookups in your Clinical Operations Vault to map document types.

Loading Mappings

Once you have created CSV mapping files for Studies, 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 your Safety Vault, review and make any update necessary for the default value for the following fields:

• Organization (safety_study_organization__v)
• Masking (safety_study_masking__v)
• Study Phase (safety_study_phase__v)
• Study Type (safety_study_type__v)

Required Fields

The Study Name field is not required in Clinical Operations Vaults, but is required in Safety Vaults. If the connection attempts to send a record from the Clinical Operations Vault to the Safety Vault without this required field, Vault generates a User Exception Message and the transfer fails. To avoid this, we recommend creating a Validation Rule that tells Vault to require the Study Name field in the Clinical Operations Vault.

Validation Rules

Safety Vaults have a custom validation rule for configuring the Blinded value if the Masking value is Double-Blind. Because the Blinded field does not exist in Clinical Operations Vaults, the Safety-Clinical Operations Vault Connection does not populate this field. Before running the connection, ensure this validation rule is inactive in your Safety Vault. Once the Study transfers through the connection, you can then populate the Blinded field in your Safety Vault.

User Exception Message Configuration

In your Safety Vault, configure the User Exception Message object as follows:

• Navigate to Admin > Configuration > Object > User Exception Message > Actions > Reprocess Request.
  • Ensure the Status is Active.
• Update the User Exception Message object layout to include a related object section for User Exception Items.
  • For Creation Option, select Prevent record creation.

Object Lifecycles

In your Safety Vault, update object lifecycles as follows:

• 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

Linking Existing Studies

When you start the Safety-Clinical Operations 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 (2) Studies manually. If you do not link existing Studies, the connection may cause errors or create duplicate Studies.

To manually link existing Studies:

1. In your Clinical Operations Vault, identify the Global ID and Study Number of the Study you want to link.
2. In your Safety Vault, open the Study you want to link.
   • In the Link field, enter the Global ID from your Clinical Operations Vault.
3. Repeat these steps to link all applicable Studies.

Configuring Safety Letters

You can configure your Vaults to distribute Safety Letters from your Safety Vault to your Clinical Operations Vault with Veeva Site Connect. This includes CrossLink documents, such as CIOMS and FDA 3500 forms, and optional cover letters.

To configure your Vaults to distribute Safety Letters:

• In your Safety Vault:
  • Enable and configure CrossLinks.
  • Review field rules for the applicable integration rules and if applicable, create new rules to support your business processes.
  • Configure the Send to Vault Clinical user action. Users can only execute this action on Distribution types of Transmissions and the action fails if it runs it on a Distribution related to a Study you have not linked to a Study in your Clinical Operations Vault.
    1. Assign the action to the Transmission object.
    2. Add the action to the appropriate lifecycle states in either of the following ways:
       • When assigning the action, select the Available in All Lifecycle State checkbox to apply atomic action security defaults.
       • Add the action as a user action to the applicable states of the Transmission Lifecycle.
  • Create a Safety Rule Set for the Vault Clinical Transmission Profile.
• In your Clinical Operations Vault:
  • Enable and configure CrossLinks.
  • Configure Veeva Site Connect.
  • Configure Safety Distributions so users can distribute the Safety Letters to sites using SiteVault.
  • Create a reference lookup to map the document types between your Vaults.
  • Map Vault Clinical Docs artifacts so that Vault knows how to classify target CrossLinks.

Mapping Vault Clinical Docs Artifacts

You must map document types and classifications in your Safety Vault to the applicable document types in your Clinical Operations Vault so that Vault classifies transferred Safety Letters correctly in your Clinical Operations Vault. To do this, assign the Expedited Safety Report and Safety Report Supporting Documents artifacts to the appropriate document types, subtypes, or classifications in your Clinical Operations Vault.

Safety Letter	Safety Document Type & Subtype	Safety Document Classification	Vault Clinical Docs Artifact
Safety Document	Case > Individual Case Safety Reports (ICSR)	E2B Plus CIOMS I E2B(R2) E2B(R3) EMA E2B (R3) FDA 3500A FDA E2B(R2) FDA VAERS E2B (R3) PMDA E2B (R2) HC E2B (E2)	Expedited Safety Report
Cover Letter	Case > Individual Case Safety Reports (ICSR)	SUSAR Cover Letter	Safety Report Supporting Documents