Vault CDMS FTP Connection Setup (CTMS)

Note: While the FTP connection described in this article continues to function, we have introduced a standard CDMS and Clinical Operations Vault Connection using Spark messaging as the recommended path to transfer record data.

The EDC to CTMS Connection feature provides a cross-domain connection between EDC and CTMS Vaults. Organizations using this feature can leverage EDC data while working in a CTMS Vault by reporting on Subject statuses and status dates captured within EDC. This connection also allows users to navigate to a Subject’s casebook in EDC from a Subject or Monitored Subject record in CTMS.

Note: This feature is only available to organizations with both Clinicial Operations CTMS and CDMS EDC Vaults.

How the FTP Connection Works

Once configured, data syncing happens automatically, with your EDC Vault “pushing” updates to your CTMS Vault on a regular basis via the FTP server. The connection schedule is set in your EDC Vault.

When data syncing occurs, Vault EDC extracts Subject status and status dates in a CSV based on the export configuration for a given Study, connects to your CTMS Vault, and places the extracted CSV into a configured folder on the FTP. See details about the FTP Loader below. Vault CTMS then ingests the CSV and creates new Subject records or updates records accordingly. We recommend using Atomic Security on Subject object fields in your CTMS Vault to prevent users from inputting incorrect data and causing connection errors.

Note: Entering Subject data in a CTMS Vault does not update related fields in the linked EDC Vault.

Connection Setup

Configuring the EDC Connection Permission Set & Security Profile

To set up the EDC connection, you must first create a new Permission Set and Security profile. Note that these options are automatically available in new CTMS Vaults.

Navigate to Admin > Users & Groups > Permission Sets and click Create. This permission set must include the following permissions:

Type	Permission Label	Controls
Security Profile	Application: File Staging: Access	Ability to access Vault's FTP staging server.
Security Profile	Application: Access API	Ability to make an API call, which is required to create and update records via FTP.
Security Profile	Application: Vault Owner Actions: Vault Loader	Ability to see and use Vault Loader to create and update records via the FTP Loader.
Security Profile	Application: All Object Records: All Object Record Read	Ability to load related data for Subject records; alternatively, you can provide Read access on a per-object basis. The connection requires Read access on at least the Study, Study Country, and Study Site objects.
Security Profile	Objects: Subject: Read, Create, Edit	Ability to create and update Subject records.
Security Profile	Tabs: Home: View	Ability to see Vault Loader files and file failures in the Notifications view.

After you create your permission set, navigate to Users & Groups > Security Profiles and click Create to create an associated security profile. In the Permission Sets section, click Add > Existing Permission Set and select your new CTMS EDC Connection Actions permission set.

User Setup

You’ll need to create a connection user who will link your EDC and CTMS applications:

Navigate to Admin > Users & Groups and click Add > New User.
From the License Type drop-down, select the Full User.
From the Security Profile drop-down, select the newly-created EDC Connection security profile. Note that this user should never have a Vault Owner security profile.
Enter the user’s Name and Email.
Select a Security Policy. We recommend configuring a security policy without an expiring password.
Click Save.

Once Vault creates the user, your organization will receive a password reset email at the email address you provided. You’ll use this password in your EDC Vault to create the FTP connection between Vault EDC to Vault CTMS. See details below.

Note that this connection user should not be used for any other purpose.

FTP Setup

Vault uses the FTP server to connect data in your EDC and CTMS Vaults. In order to connect your Vaults, you must create a new directory on your FTP server named “vaultloader” in the connection user’s directory.

EDC Setup

After you configure your CTMS Vault and FTP server, you must create an FTP Connection in your EDC Vault. See About the Veeva Vault CTMS Connection for details on configuring this connection.

Default Configurations

CTMS Vaults include the following standard configuration elements to support connection with EDC:

EDC ID Field

The EDC ID (edc_id__v) field in CTMS Vaults is a unique identifier for connection upserts, allowing EDC to connect a Subject with the correct Site and push data over. This field is available on the following objects:

Study
Study Country
Study Site
Subject
Monitored Subject (This is a lookup field to the EDC ID field on the Subject record)
Subject Visit
Monitored Subject Visit
Visit Definition
Study Arm

Vault populates the EDC ID field by default on the Study, Study Country, and Study Site objects, but users can update it later to ensure that the field matches and syncs correctly across EDC and CTMS Vaults. Note that if the Study, Study Country, and Study Site record names are the same in your EDC and CTMS Vaults, you shouldn’t need to update the EDC ID field later.

Depending on your CTMS configuration, you may want to remove the EDC ID field from your object page layouts or configure field-level security to prevent users from editing the field and disrupting connection.

Subject Object Fields

The following fields appear on the Subject (subject__clin) object page layout in support of connection with EDC data:

Subject ID
Subject Status
Screened Date
Screen Failed Date
Enrolled Date
Randomized Date
Withdrawn Date
End of Treatment Date
Complete Date
EDC ID

Subject Statuses

The following standard picklist values are available in the Subject Status picklist (subject_status__clin), which is used to select a status in the Subject Status field on Subject and Monitored Subject records:

Pre Screening
In Screening
Screen Failure
Enrolled
Randomized
Withdrawn
End of Treatment
Complete

Lifecycle

The Subject object lifecycle (subject_lifecycle__v) allows Admins to configure the Open Casebook user action on the Subject object.

Note that you must first manually assign this lifecycle to the Subject object. To do this, navigate to the Subject object from Admin > Configuration > Objects, click Edit, and select the Subject lifecycle from the Lifecycle drop-down.

You can configure a web action and associated user actions that allow cross-domain users with access to both EDC and CTMS Vaults to open an EDC Casebook record from CTMS. What actions a user can perform after opening a casebook from CTMS depends on their EDC permissions for that Subject casebook.

Configuring the Web Action

Note: We recommend working with Veeva Services to create an Open Casebook web action.

To create the web action yourself:

Navigate to Admin > Configuration > Web Actions and click Create.
Enter a Label. We recommend “Casebook Navigation”.
In the Type drop-down, select Object.
In the Target drop-down, select Open in New Window.
In the URL window, enter the following URL, replacing the bolded text (including carets) with your EDC Vault ID: https://${Vault.domain}/ui/veevaHome/switchVaultWithTarget/<EDC-vault-ID>?tg=%2F%23t%2F0TB000000000301%3D%26cn%3Dsubject__v%26cf%3 Dexternal_id__v%26cid=${Object.edc_id__v}&src=cl
Click the Validate button to validate your URL.
Click Save.

Note that you can find your EDC Vault ID by navigating to Admin > Settings in your EDC Vault.

You can configure user actions on your Subject and Monitored Subject objects to allow users to open a related Casebook record. We recommend adding an Open Casebook action on the In Progress and Complete states of the Monitored Subject object lifecycle, and the Active state of the Subject object lifecycle.

Your user action should be a Web Action user action that includes the following condition: If EDC ID is not blank. Learn more about creating user actions. Learn more information about defining user actions.