Configuration for the EDC/CTMS Spark Connection


For the spark integration to work, an Admin must configure the relevant components and activate the connection. This setup requires configuration steps in both the EDC (CDMS) and CTMS vaults.

Prerequisites

  • Your organization must have a CTMS (Clinical Operations) vault and an EDC (CDMS) vault.
  • Your organization must use Set Subject Status rules.

Required Permissions

Users with the Vault Owner permission can perform all of these configuration actions by default. If your vault uses custom Security Profiles to allow users within your organization to access the Admin area, you must have the following permissions:

Type Permission Controls
Security Profile Application: Manage Connections Ability to access Admin > Connections and establish Connections
Security Profile Objects: Study: Edit,
Objects: Study Country: Edit,
Objects: Country: Edit,
Objects: Study Site: Edit
Ability to edit records in the Study, Study Country, Country, and Study Site objects

Learn more about permission sets.

Vault EDC/CTMS Spark Connection Components

The following standard components exist for use with the Vault EDC/CTMS Spark Connection:

Connection

The following Connection record is available from Admin > Connections:

  • CDMS/Clinical Operations Connection (cdms_clinops_connection__v) is available in both your CTMS vault and EDC vault.

Note that you’ll still need to establish the Vault to Vault connection before you can use it.

Integration Points

The CDMS/Clinical Operations Connection record includes the following default Integration records with standard Integration Point records in your CDMS vault:

Integration Name Integration Point Name Sent From Sent To Included Data
CDMS to CTMS Subject Data Subject Transfer EDC CTMS
  • End of Study Date
  • End of Treatment Date
  • Enrolled Date
  • Subject ID
  • Randomized Date
  • Screen Fialed Date
  • Screened Date
  • Site
  • Study
  • Study Country
  • Subject Status
  • Withdrawn Date
  • Global ID
CDMS to CTMS Subject Event Data Event Definition Transfer EDC CTMS
  • Description
  • Event Type
  • Help Content
  • Name
  • Study
  • Private Key
Event Transfer EDC CTMS
  • DMR Date
  • Event Date
  • Event Definition
  • Event Sequence
  • Event Status
  • Name
  • Overdue Date
  • Planned Date
  • Review for DMR
  • Review for SDV
  • SDV Date
  • Site
  • Study
  • Study Country
  • Subject
  • Global ID
CTMS to CDMS Study Data Study Transfer CTMS EDC
  • Study Number
  • Study Phase
  • Lifecycle State
  • Global ID
Study Country Transfer CTMS EDC
  • Country
  • Study Country Name
  • Study Number
  • Global ID
Study Site Transfer CTMS EDC
  • Study Site Number
  • Site Name
  • Lifecycle State
  • Study Country
  • Site Timezone
  • Global ID

Configuration Overview

The following tasks are required to configure the connection:

  • In the CTMS vault: Add fields and a user action to the relevant objects. See details here.
  • In the EDC vault: Create Set Subject Status rules for the Subject Status field if they don’t already exist.
  • In the EDC vault: Create or update the Study Status and Site Status reference lookups as necessary.
  • In both the CTMS and EDC vaults: Map objects, object field reference lookups, and connect any pre-existing records across both vaults.
  • Establish the connection in both vaults.

For any configurations in the CTMS vault, instructions are available here.

Configure the Study & Site Status Reference Lookups

In EDC, there are Reference Lookups for the following fields:

  • Study > Study Status: The Study lifecycle in CTMS maps to the Study Status picklist values in EDC.
  • Site > Site Status: The Site lifecycle state in CTMS maps to the Study Status picklist values in EDC.

If your CTMS vault has custom Study or Site lifecycle states, add them as additional Reference Lookups in the EDC vault:

  1. In the EDC vault, navigate to Admin > Connections > CDMS to CTMS Connection > Reference Lookups.
  2. Select the study_status__v or site_status__v reference lookup.
  3. Click Add.
  4. For Source Key, enter the Name of the custom lifecycle state from the CTMS vault.
  5. Select the appropriate Target Key in EDC. This is the Study Status that you want to associate with the custom lifecycle state.
  6. Click Save.
  7. Repeat these steps for all custom Study or Site lifecycle states in CTMS.

Configure the Study Phase Reference Lookup

Each Study Phase in Clinical Operations must map to a Study Phase in EDC. Because Study Phase is a system-configured field in EDC and a custom field in CTMSClinical Operations, this mapping must be configured manually:

  1. In the EDC vault, navigate to Admin > Connections > CDMS to CTMS Connection > Reference Lookups.
  2. Select the study_phase__v reference lookup.
  3. Click Export Template.
  4. Open the exported CSV file in an editor.
  5. In the CTMS vault, navigate to Admin > Business Admin > Picklists and click into the Study Phase picklist.
  6. Copy and paste the source name (Picklist Value Label) and source key (Picklist Value Name) to the CSV file. Ensure that you match the Picklist Value Label _and name from the CTMS vault with the _Picklist Value Label and name from the EDC vault. Multiple items from CTMS can map to one item in EDC. You can add custom picklist values to EDC as desired. Every picklist value from the CTMS vault should be mapped to avoid errors. The resulting CSV file may look similar to this example: Example template CSV file

  7. Save the CSV file in the editor.
  8. In the EDC vault, navigate to Admin > Connections > CDMS/Clinical Operations Connection > Reference Lookups and load the reference lookup template onto the study_phase__v reference lookup.

Mapping the Country Object

Country object records must be mapped between EDC and CTMS in order to create Study Country object records:

  1. In both the CTMS vault and the EDC vault, use Vault Loader to export Country object records. Ensure that you select the Include Non-editable Fields checkbox.
  2. Open the resulting CSV files in an editor.
  3. Use a VLOOKUP function to populate the appropriate Link field (in EDC) with the value from the Global ID field (in CTMS) in an input spreadsheet file. For more information on using a VLOOKUP function, see the documentation for your spreadsheet editor.
  4. If any Countries do not automatically resolve via the VLOOKUP function, manually add them to the input spreadsheet. Any countries that exist in one vault but not the other should be created and mapped in the other vault.
  5. Save the file with the completed id and link__sys columns.
  6. Load the CSV file into the EDC vault.

Connecting Existing Record Data

Depending on your configuration prior to implementing this Spark Messaging connection, there may be different versions of data in each vault. This section describes what to do in each of these scenarios.

All steps described in this section should be completed before setting the Connect to Vault CDMS in CTMS vaults or the Connect to Vault Clinical Operations in EDC vaults to “Yes”.

Locate the situation that most closely matches yours, click to expand it, and follow the steps.

  • Create the Study manually in EDC, add the Global ID for that Study from CTMS into the Link field for that Study in EDC.
  • Set the Connect to Vault CDMS field in CTMS to “Yes”.
  • The Spark Messaging connection updates the Study in EDC with data from CTMS, and creates all the Study Countries and Sites from the CTMS data for that Study.
  • For each Study, take the Global ID from CTMS and copy its value to the Link field for the corresponding Study in EDC.
  • For each Study Country, take the Global ID from CTMS and copy its value to the Link field for the corresponding Study Country in EDC.
  • For each Site, take the Global ID from CTMS and copy its value to the Link field for the corresponding Site in EDC.
  • Set the Connect to Vault CDMS field in CTMS to “Yes”.
  • The Spark Messaging connection updates the Study, Study Country and Site in EDC with data from CTMS
  • Note that these steps can also be performed with Vault Loader in EDC.
  • Create all Studies, Study Countries, and Sites from EDC in CTMS.
  • For each Study, take the Global ID from CTMS and copy its value to the Link field for that Study in EDC.
  • For each Study Country, take the Global ID from CTMS and copy its value to the Link field for that Study Country in EDC.
  • For each Site, take the Global ID from CTMS and copy its value to the Link field for that Site in EDC.
  • Set the Connect to Vault CDMS field in CTMS to “Yes”.
  • The Spark Messaging connection updates the Study, Study Country and Site in EDC with data from CTMS.
  • Note that these steps can also be performed with Vault Loader in EDC.
  • This is not a valid case for this Spark Messaging connection, this information may be pulled in from an external EDC system.
  • Ensure the Study, Study Country, and Site are connected to CTMS per the steps provided in the previous configuration sections.
  • For each Subject, take the Global ID from EDC and copy its value to the Link field for the corresponding Subject in CTMS.
  • For each Event, take the Global ID from EDC and copy its value to the Link field for the corresponding Subject Visit in CTMS.
  • For the latest version of Event Definitions, take the Private Key from CTMS and copy its value to the Link field for that Visit Definition in EDC.
  • Set the Connect to Vault CTMS field in EDC to “Yes”.
  • The Spark Messaging connection updates the Subject, Subject Visit and Visit Definitions in CTMS with data from EDC.
  • Note that these steps can also be performed with Vault Loader in CTMS.
  • Ensure the Study, Study Country and Site are connected to CTMS per the steps provided in the previous configuration sections.
  • Set the Connect to Vault CDMS field in CTMS to “Yes”.
  • The Spark Messaging connection updates the Subject, Subject Visit and Visit Definitions in CTMS with data from EDC.

Establish the Connection

Once you’ve completed the required configuration in both vaults, you can establish (activate) the connection. Once the connection is established, Vault EDC and Vault CTMS will begin sharing data.

To establish the connection:

  1. In the EDC vault, navigate to Admin > Connections > CDMS to CTMS Connection.
  2. From the Actions menu, select Download Connection File.
  3. In the Download Connection File dialog, click Download.
  4. In the CTMS vault, navigate to Admin > Connections > CDMS to CTMS Connection.
  5. From the Actions menu, select Connect from File.
  6. Click Choose and select the connection file you downloaded in step 3.
  7. Click Continue.
  8. If the connection file included a Remote Vault ID, the connection is now established. Both connection records are now in an Active state.
  9. Optional: If the configuration file does not include a Remote Vault ID, an Approval Workflow will begin in both vaults. Navigate to the Connection record in each vault and click Complete.
  10. Optional: In the dialog that appears, choose to Approve the connection. The connection record is now in the Approved statue. Once both vaults approve the connection, both records move to the Active state and the connection is established.