Configuring the Safety-EDC Vault Connection

Using the Safety-EDC Vault Connection, organizations with both a Safety Vault and a CDMS Vault can exchange data in near-real time. To use the Safety-EDC Vault 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. Configure your Vaults.
  3. Establish the Vault to Vault connection between your Safety and CDMS Vaults.

Safety-EDC Vault Connection Components

The components in the following sections support the standard Safety-EDC Vault Connection.

Connections

The following Connection records are available from Admin > Connections:

  • Safety-EDC Connection (safety_cdms_connection__v) is available in your Safety Vault.
  • Safety-EDC Connection (safety_cdms_connection__v) is available in your CDMS Vault.

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.

Integration Name Integration Point Name(s) Sent From Sent To Included Data
Safety-EDC: Serious Adverse Event Safety-EDC: Safety Case Outbound CDMS Safety SAE and Subject information
Safety-EDC: Serious Adverse Event Safety-EDC: CDMS Safety Case Inbound Safety CDMS SAE and Subject information
Safety-EDC: Serious Adverse Event Safety-EDC: Case Information CDMS Safety SAE Case information
Safety-EDC: Serious Adverse Event Safety-EDC: Case Information Safety CDMS SAE Case information

Queues

This feature includes four (4) standard message processing queues: two (2) in the Safety Vault and two (2) in the CDMS Vault. You can access and manage these queues from Admin > Connections > Spark Queues.

In the Safety Vault:

  • Safety-EDC SAE Inbound (cdms_to_safety_sae_inbound_queue__v)
  • Safety Outbound Messaging Queue (cdms_to_safety_sae_outbound_queue__v)

In the CDMS Vault:

  • Safety-EDC SAE Outbound (cdms_to_safety_sae_outbound_queue__v)
  • Safety-EDC SAE Inbound (cdms_to_safety_sae_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 Safety-EDC Vault Connection. If your Safety Vault 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.

Configuring Your Vaults

To configure your Safety and CDMS Vaults to support the Safety-EDC Vault Connection:

  1. Follow the steps in CDMS Help.
  2. Configure your Safety Vault.
  3. Configure Study and Study Product matching.

Configuring Your Safety Vault

After completing all the required configurations in CDMS Help, complete the following in your Safety Vault:

  1. Review Administering Vault Safety for more details about connections in Vault Safety.
  2. Configure object layouts:
    • Add the CDMS Subject Information field to the Details section of the Inbox Item object layout.
    • Add the Subject Information Review field to the Details section of the Case Access Group Assignment Detail layout for the Case Access Group object.
  3. For the Pregnancy (pregnancy_case__v) Yes/No field on the CDMS Subject Information object, ensure the Show as checkbox checkbox is clear.
  4. Create the appropriate sponsor Organization to which you will assign the applicable Studies, Products, and Study Products. This record must be a “Sponsor” type of organization.
  5. Configure Case Access Group Security to control user access to subject information on SAE data received from your CDMS Vault.
    • For the applicable Case Access Groups, create a Case Assignment Rule with an Intake Method for the CDMS Connection.
    • For the applicable Case Access Group Assignments, update the Subject Information Review field to Subject Information Review.
  6. Configure the Add Relevant Subject Information user action on the Case object so users can view and select subject information to add to a Case.
    • This action is only available to users with the appropriate Case Access Group on Cases with related subject information from your CDMS Vault.
    • Vault will automatically generate Assessments when users run the Add Relevant Subject Information action if the Generate Assessments for both Serious and Non-Serious Adverse Events checkbox is selected on the Admin > Settings > Safety General Settings page.

  7. Configure Merge to In-Flight Case

  8. Configure Automated Case Promotion .
    • Configure Case Promotion Settings .
    • For the CDMS to Safety Connection transmission profile, ensure the Enable Auto Promote field is Yes.

Study & Study Product Matching

Vault can automatically match and populate the appropriate study-related fields on records created and updated from data received from the Safety-EDC Vault Connection. To support matching, Study and Product records must have the same names in your Vaults so that Vault can automatically match and populate the appropriate product- and study-related fields on records created and updated from transferred CDMS data. To do this:

  • Ensure that Studies and Products have the same values in your Safety and CDMS Vaults for the following fields to ensure matching:
    • Studies must have matching Study Numbers (name__v).
    • Products must have matching Product Names (name__v).
    • Study Products must have matching Names (name__v).
  • In your Safety Vault:
    • Create the appropriate Study Product Placeholders .
    • Add Study Products with the appropriate matching Blinded Names to the applicable Studies.
    • Select the appropriate “Sponsor” type of Organization for the Studies, Products, and Study Products.

If your organization also utilizes the Safety-Clinical Operations, Safety-RIM, and Clinical Operations to CDMS Vault Connections, Vault matches Studies between all Vaults based on the matching values.

Establishing the Connection

When you’ve made all required configurations described above, establish the Vault to Vault connection between your Safety Vault and your CDMS Vault. See Creating & Managing Connections for detailed instructions.