Configuring the Safety-EDC Vault Connection

Using the Safety-EDC Vault Connection, you can exchange data in near-real time between Safety and CDMS EDC Vaults. 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 your Safety and CDMS Vaults to configure the standard connection:

Review the connection components and adjust as needed to fit your organization’s business processes.
Configure your Vaults.
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 Events	Safety-EDC: Safety Case Outbound	CDMS	Safety	SAE and Subject information
Safety-EDC: Serious Adverse Events	Safety-EDC: CDMS Safety Case Inbound	Safety	CDMS	SAE and Subject information
Safety-EDC: Serious Adverse Events	Safety-EDC: Case Information	CDMS	Safety	SAE Case information
Safety-EDC: Serious Adverse Events	Safety-EDC: Case Information	Safety	CDMS	SAE Case information
Safety-EDC: Serious Adverse Events	Safety-EDC: Safety Inbox and Case IDs	Safety	CDMS	Inbox IDs and Case IDs

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:

Follow the steps in CDMS Help.
Configure your Safety Vault.
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:

Ensure you have completed all the steps in Enable the Safety-EDC Vault Connection.
Optional: Map custom fields so that the mapped fields automatically populate with the data received from the Safety-EDC Connection on the related Subject Information and Case objects.
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.
- Optional: To support sending reporter details to Vault Safety, add all reporter-related fields to your default CDMS Subject Adverse Event object layout in the applicable reporter details section.
For the Pregnancy (pregnancy_case__v) Yes/No field on the CDMS Subject Information object, ensure the Show as checkbox checkbox is clear.
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.
Configure Case Access Group Security to control user access to subject information on SAE data received from CDMS Vaults.
- For the applicable Case Access Groups, create a Case Assignment Rule with an Intake Method for the CDMS Connection (Safety-EDC Connection).
- For the applicable Case Access Group Assignments, update the Subject Information Review field to Subject Information Review.
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 the CDMS Vault.
- Vault will automatically generate Assessments when users run the Add Relevant Subject Information action if you’ve selected the Generate Assessments for both Serious and Non-Serious Adverse Events checkbox on the Admin > Settings > Safety General Settings page.
Assign users Read permission for the CDMS subject information objects.
Optional: Configure the Copy to new action on the applicable states of the Connection object lifecycle to connect to multiple CDMS EDC Vaults.
Optional: Optional: Configure Merge to In-Flight Case.
Optional: Optional: Configure Automated Case Promotion.
- Configure Case Promotion Settings.
- For the Safety-EDC Connection transmission profile, ensure the Enable Auto Promote field is Yes.

Mapping Custom Fields

You can map custom fields in your CDMS Vault to your Safety Vault so that the mapped fields automatically populate with the data received from the Safety-EDC Connection on the related subject information and case objects. The fields must have the exact same names on the Safety-related Form Type in CDMS as well as on the corresponding objects in your Safety Vault. These custom fields must be a supported field type.

To map custom fields:

In your Safety Vault, add custom fields to the relevant CDMS subject information and case objects. Ensure the fields you add to the corresponding objects have the exact same name values.
In your CDMS Vault, map the custom fields to the corresponding Form Types. Ensure the names have the exact same name values as the custom fields you added to the corresponding objects in your Safety Vault.

CDMS Subject Information Object in Safety	Case Object in Safety	Form Type in CDMS
CDMS Subject Adverse Event	Case Adverse Event	Serious Adverse Event
CDMS Subject Medical History	Case Medical History	Medical History Form
CDMS Subject Drug History	Case Drug History	Drug History Form
CDMS Subject Case Product	Case Product	ConMed Form
CDMS Subject Case Product Dosage	Case Product Dosage	Study Drug Form
CDMS Subject Test Result	Case Test Result	External Labs Form
CDMS Subject Cause of Death	Case Cause of Death	In Case of Death Form
CDMS Subject Information	Case	Patient Characteristics From

Note: If these fields are not mapped correctly users cannot select the related subject in the Add Relevant Subject Information dialog after running the Add Relevant Subject Information action.

Supported Fields

Vault supports the following object field types for mapping custom fields between CDMS and Safety Vaults:

Date
Number
Object (for the Controlled Vocabularies object)
Picklist
Text
Yes/No

Sending SAE Reporter Details

You can configure the general settings in your CDMS Vault so that the connection sends reporter details to Vault Safety for all SAEs. To support this, ensure the Reporter field value on the Safety Settings page in your CDMS Vault is Full Site Information.

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-CDMS Vault Connections, Vault matches Studies between all Vaults based on the matching Link (link_sys) values. If there are no common Link values, Vault matches studies based on the Study matching logic.

Establishing the Connection

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

Multiple Connections

You can connect your Safety Vault to multiple CDMS EDC Vaults. Use the Copy to new action on an existing connection to deep copy an existing connection, and its related components, in the same status as the copied components.

To copy an existing connection:

Navigate to Admin > Connections.
From the All Actions menu of the connection you want to copy, select Copy to new. This action is executable only for Safety-EDC Connections.
Optional: Change the label of the newly generated Connection.

Note: Vault supports up to ten (10) EDC connections in a Safety Vault. Contact your Veeva Representative if you require additional connections.