Send Procedure Notifications to CTMS (Studio)

You can configure your study to send information about procedures to your organization’s CTMS vault. For example, if you have a Form that collects data about a CT scan, you can have EDC send that information to CTMS to be tracked as a Procedure for payments (learn more about Vault Payments). The Create Integration Record rule action creates an Integration Record, which initiates the process to send the Procedure to CTMS.

Prerequisites

Feature Enablement

This feature must be enabled in your Study by a Vault Owner. For studies created after the 23R2 release (August 2023), this feature is automatically enabled. Procedures defined prior to enablement must be removed before the feature is enabled to ensure successful deployment and prevent errors. Once the feature flag is removed, the procedures should be reconfigured in Studio in the DEV environment.

To enable this feature:

  1. Navigate to Admin > Business Admin > Study Configurations.
  2. Click your Study to open its Study Configuration record.
  3. Click Edit.
  4. For Integration Configuration Version, select Configuration Deployed.
  5. Click Save.
Configuration

An administrator in the CTMS vault must create the required Procedure Definition records for each Procedure that your organization will collect data for in EDC.

Required Permissions

Users with the CDMS Lead Data Manager study role can perform the actions described below by default. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Studio Tab

Ability to access the Studio tab
Functional Permission View Integration Mappings

Ability to view Integration Mappings from EDC Tools > Integration Configuration
Functional Permission Edit Integration Mappings

Ability to edit Integration Mappings from EDC Tools > Integration Configuration

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

How to Configure the Integration

Create an Integration Configuration for each Procedure that you want to track.

To create an Integration Configuration:

  1. Navigate to Studio > Integration Configuration for your Study.
  2. Click + New Integration Configuration.
  3. Enter a Name for the integration.
  4. Select Procedures for Integration Type.
  5. Select an Event Group and Event as a Casebook Reference to map to. You can also select a Form. This selection determines which Event and Form describe the procedure.
  6. Select a Status.
  7. Select a Reference Type.
  8. Click into the Reference Value field to set the value.
  9. Depending on your selection for Reference Type, do one of the following for Reference Value:
    • Study Reference: Either leave the selection at the Form-level or also select an Item Group and Item as the Study Reference, then click Save.
    • Static Value: Enter the value (up to 128 characters) and then click away from the Reference Value field.
    • Map Values to System Actions: Select a Field Value for each System Action. Then, click Save.
  10. Repeat steps 7 through 9 for each Field Mapping.
  11. Click Save.

Repeat these steps for each Procedure.

In the current release, repeating Item Groups are not supported.

Field Mappings

Field mapping references can be Study References or Static Values. Some references can use Map Values to System Actions.

A Study Reference mapping pulls the information from a data entry user-entered value collected as part of the study. For example, a date-type Item on the Form. A Static Value fills the field with whatever value you provide for the Reference Value.

For the Procedure Status field, you can also choose to Map Values to System Actions. This option allows you to choose certain system actions, such as form submission, to map to statuses.

The table below describes each Field Mapping available for Procedures:

Field Mappings for Procedures
Field Required Description
Procedure Date Yes The Date of the Procedure sent to CTMS.

*Procedures cannot be created for partial dates.
Procedure Definition Yes

The Procedure Definition to use when sending the information to CTMS. CTMS creates a Procedure based on this definition when the EDC data is received.

Use Static Value as the Reference Type and enter the Name of the Procedure Definition record (from CTMS) as the Reference Value. This must be an exact match. Work with the administrator of your organization’s CTMS vault to get this value.
Procedure Status Yes

The Status assigned to the Procedure in CTMS.

If you choose Map Values to System Actions for the Reference Type, you can map the Submitted, Deleted, and Reset system actions to statuses. Then, EDC will send an update to CTMS each time a data entry performs one of those actions on the EDC Form.

If you use a Study Reference or Static Value, it must yield one of the following status values: Did Not Occur, Planned, Blank, Submitted, or In Progress.
Visit Name No The Name of the visit sent to CTMS to populate the Visit Name (Event Name).

Edit an Integration Configuration

You can edit an Integration Configuration while your Study is in progress.

Any changes you make to an Integration Configuration will not apply to existing Procedures. To apply those configuration changes, existing procedure Forms must be resubmitted.

To edit an Integration Configuration:

  1. Navigate to Studio > Integration Configurations for your Study.
  2. Locate the Integration Configuration you want to edit in the list.
  3. Hover over the Name of the Integration Configuration to show the Actions menu.
  4. From the Actions menu, select Edit.
  5. Make your changes.
  6. Click Save.

Delete an Integration Configuration

You can delete an Integration Configuration.

When you delete the configuration for the procedure, it only stops Vault from creating any new Procedures. Vault doesn’t delete any existing Procedure records in CTMS.

To delete an Integration Configuration:

  1. Navigate to Studio > Integration Configurations for your Study.
  2. Locate the Integration Configuration you want to delete in the list.
  3. Hover over the Name of the Integration Configuration to show the Actions menu.
  4. From the Actions menu, select Delete.
  5. In the confirmation dialog, click Delete.

Create Integration Records via Rules

You can use a Rule with the Create Integration Record action type to create an Integration Record when certain conditions are met. When Vault creates an Integration Record, CDMS sends your Procedure to CTMS.

Known Issue: When the criteria specified aren’t met for Procedures driven by rules, Vault still creates a Procedure with the Blank status.

To create a Create Integration Record rule:

  1. Navigate to Studio > Rules for your Study.
  2. Enter your rule details and expression. For more information, see Creating Rules.
  3. For the Action, select Create Integration Record.
  4. Click Select Integration Configuration.
  5. For Integration Definition, select the Integration Configuration you created.
  6. Click Save.
  7. To save your rule, click Save.