Configuring the Clinical Operations to CDMS Vault Connection

Using the Clinical Operations to CDMS Vault Connection, organizations with both a Clinical Operations CTMS Vault and one or more CMDS EDC Vaults can exchange data in near-real time. To use the Clinical Operations to CDMS Vault Connection, you must configure the relevant components, connect any existing data, and activate the connection. This setup requires configuration steps in both Vaults.

Clinical Operations to CDMS Vault Connection Components

Connection

CDMS/Clinical Operations Connection (cdms_clin-ops_connection__v) is available in both your CTMS Vault and EDC Vault in Admin > Connections. You must establish the Vault to Vault connection before you can use this Connection. Once you have configured one connection, you can easily copy it to create a new connection.

Integrations

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

Integration Name

Integration Point Name(s)

Sent From

Sent To

Included Data

Study Data Integration

Study Integration Point

CTMS

EDC

  • Study Number
  • Study Phase
  • Lifecycle State
  • Global ID

Study Country Integration Point

CTMS

EDC

  • Country
  • Study Country Name
  • Study Number
  • Global ID

Site Integration Point

CTMS

EDC

  • Study Site Number
  • Site Name
  • Lifecycle State
  • Study Country
  • Site Timezone
  • Global ID

Subject Data Integration

Subjects Integration Point

EDC

CTMS

  • End of Study Date
  • End of Treatment Date
  • Enrolled Date
  • Subject ID
  • Randomized Date
  • Screen Failed Date
  • Screened Date
  • Site
  • Study
  • Study Country
  • Subject Status
  • Withdrawn Date
  • Global ID

Visit Definitions (Event Definitions)

Visit Definition Integration Point

EDC

CTMS

  • Description
  • Event Type
  • Help Content
  • Name
  • Study
  • Private Key

Subject Visit Data

Subject Visit Integration Point

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
  • SDV Mode*
  • Site
  • Study
  • Study Country
  • Subject
  • Global ID
  • Visit Name**
  • Repeating Visit**

Protocol Deviations

Protocol Deviations Transfer Integration Point

EDC

CTMS
  • Category
  • Content (blinding__v)
  • Date of Deviation
  • Date Identified
  • Description
  • Lifecycle State
  • Link ID
  • Resolution
  • Severity
  • Status
  • Study
  • Study Country
  • Study Site
  • Sub Category
  • Subject
  • Subject Visit
  • Summary

Procedures Integration

Procedures Transfer Integration Point

EDC

CTMS

  • Study
  • Study Country
  • Study Site
  • Subject
  • Subject Visit
  • Procedure Definition
  • Link ID
  • Procedure Status
  • Procedure Date

*The connection only transfers this data if SDV Requiredness is enabled in your Vault.
**The connection only transfers this data if Repeating Visits are enabled in your Vault.

Initial Configuration Overview

You only need to complete the steps in this section once to configure the Clinical Operations to CDMS Vault Connection:

CTMS Object Field Configuration

Update the following object fields in CTMS:

  • Add the Connect to Vault CDMS field to the Study page layout.
  • Add the Study Phase field to the Study object page layout and make it a required field.
  • Add the Site Timezone field to the Site object page layout and make it a required field.
  • Make the Organization field on the Site object a required field.
  • Ensure the Subject ID field on the Subject object is not unique.
  • Ensure the summary_ctms field on the pdv_clin object has a field length of at least 500 characters.
  • Change the Review for SDV field label on the Subject Visit object to SDV Complete?
  • Change the Review for DMR field label on the Subject Visit object to DMR Complete?
  • Change the Review for SDV field label on the Monitored Subject Visit object to SDV Complete?

We recommend creating Formula fields to allow users to easily navigate between the Subject and Subject Visit records in CTMS and the Subject and Event records in EDC. For each object, label the new field Casebook Link, set the Return Type to Link, and enter a Formula Expression that links to the Review tab in EDC:

  • For the Subject object: if(IsBlank(link__sys),null,Hyperlink(Concat('/#t/0TB000000000601 =&cn=subject__v&cf=global_id__sys&cid=', link__sys), 'View in EDC', 'new_window', @Connection.EDC_CTMS_connection__v))
  • For the Subject Visit object: if(IsBlank(link__sys),null,Hyperlink(Concat('/#t/0TB000000000601 =&cn=event__v&cf=global_id__sys&cid=', link__sys), 'View in EDC', 'new_window', @Connection.EDC_CTMS_connection__v))
  • For the Monitored Subject object: if(IsBlank(subject__ctmsr.link__sys),null,Hyperlink(Concat('/#t/0TB000000000601 =&cn=subject__v&cf=global_id__sys&cid=', subject__ctmsr.link__sys), 'View in EDC', 'new_window', @Connection.EDC_CTMS_connection__v))
  • For the Monitored Subject Visit object: if(IsBlank(visit__vr.link__sys),null,Hyperlink(Concat('/#t/0TB000000000601 =&cn=event__v&cf=global_id__sys&cid=', visit__vr.link__sys), 'View in EDC', 'new_window', @Connection.EDC_CTMS_connection__v))

These Formula Expressions will launch the EDC Review tab in a new browser window. If the links do not work as expected, find the Tab ID for the Review > My Studies sub-tab in EDC and substitute that number for “0TB000000000601” in each Formula Expression above.

User Exception Message Configuration

Make the following changes to the User Exception Message object configuration:

  • Navigate to Admin > Configuration > Objects > User Exception Message > Actions and create a new action. Select the Reprocess Request action and click Save.
  • Update the User Exception Message object page layout to include a related object section for User Exception Items. Select the radio button to Prevent record creation.
  • Ensure that the columns in the User Exception Items section are in the following order:
    • Exception Item Name
    • Error Type
    • Error Message
    • Item
    • Item Data

Configuring Flash Reports

We suggest creating a flash report to track and resolve any issues that occur with the connection. First, create a new Report Type:

  1. Navigate to Admin > Configuration > Report Types and click Create.
  2. Populate required fields.
  3. Select User Exception Messages as the Primary Reporting Object.
  4. Click Add Related Object, select User Exception Items (Child) as the Related Object.
  5. Click Save.

Next, create the report:

  1. Navigate to the Reports tab and click Create.
  2. Select the User Exception Message with User Exception Item Report Type and click Continue.
  3. Add the following User Exception Message filters:
    • Status equals Active
    • Created Date is in the last 1 day
    • In the CTMS Vault: Integration in Study Data, Subjects, Subject Visits (Events), Visit Definitions (Event Definitions), Procedures, and Protocol Deviations
    • In the EDC Vault: Integration in EDC to CTMS Subject Data, EDC to CTMS Subject Event Date, and CTMS to EDC Study Data
  4. Click Edit Columns and add the Error Type, Error Message, Item, and Item Date columns.
  5. Save the report.
  6. Schedule the report to run daily and select the Only send when at least one record is returned option from the Email and Vault notification preferences drop-down.
  7. Update the Sharing Settings for the report to ensure it is sent to the necessary users. We recommend sharing with one or more users on your IT team.

Configuring the Study & Site Status Reference Lookup

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

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

If the CTMS Vault has custom Study or Site lifecycle states, you should add additional Reference Lookups in the EDC Vault:

  1. In EDC, 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. Add the Name of the custom lifecycle state from CTMS as the Source Key and select the appropriate Target Key in EDC.
  5. Click Save.
  6. Repeat these steps for all custom Study or Site lifecycle states in CTMS.

Configuring the Study Phase Reference Lookup

Each Study Phase in CTMS must map to a Study Phase in EDC. Because Study Phase is a system-configured field in EDC and a custom field in CTMS, you must configure this mapping 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 EDC. 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 CTMS should be mapped to avoid errors. The resulting CSV file may look like this: Mapping CSV Example
  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 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, add them to the input spreadsheet manually. If any countries exist in one Vault but not the other, create these countries and map them 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.

Configuring the Business Admin Menu in EDC

Navigate to Admin > Configuration > Objects > Study Country and click Edit. Select the Display in Business Admin checkbox and click Save.

Enabling Restricted Data Transfer

By default, the CDMS and Clinical Operations Vault Connection only supports unrestricted (blinded in CTMS) data transfer. You can enable restricted (unblinded in CTMS) data transfer for Subject Visits and Protocol Deviations, allowing users to manage and track all subject activity from CDMS. Access to restricted data is limited to users with access to the unblinded information in CTMS.

When enabled, Vault checks the event in CDMS for restricted data. If present, Vault creates an Unblinded Subject Visit Data object record to store the unblinded data.

This feature also controls the transfer of restricted and unrestricted protocol deviation data. When the Protocol Deviation integration is active, CDMS Vaults only transfer unrestricted protocol deviations by default. Once you enable restricted data transfer, CDMS transfers both restricted and unrestricted protocol deviations.

If deleted item marking is enabled in your Vault, Vault deletes both the blinded and unblinded data in a Subject Visit record, regardless of whether restricted data transfer is enabled. Vault also deletes all protocol deviations for the given Subject Visit.

To enable this feature, navigate to Admin > Settings > Application Settings > CTMS Features and select the Enable Restricted Data Transfer checkbox.

Study Configuration Overview

After you complete the initial configuration, you’ll need to perform the steps in this section for every study in your EDC Vault that you want to connect to your CTMS Vault. Follow the best practice guidelines in this section to ensure that the connection functions correctly.

Configuring the Subject Status Rule in EDC

Subject Status and Subject Status Date field values are important pieces of information in Clinical Operations. We recommend that you create a rule in the EDC Vault to populate Subject Status and Subject Status Dates in the EDC Vault, to be sent to CTMS.

Connecting Existing Record Data

Depending on your configuration prior to implementing this connection, there could be different data in each Vault. This section describes what to do in each of these scenarios.

If Study, Study Country, and Site exist in CTMS, but do not exist in EDC:

  • Create the Study manually in EDC and 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 on the Study record in CTMS to Yes.
  • The 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.

If Study, Study Country, and Site exist in both CTMS and EDC:

  • 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 connection updates the Study, Study Country, and Site in EDC with data from CTMS.

You can also perform these steps with Vault Loader in EDC.

If Study, Study Country, and Site do not exist in CTMS, but exist 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 connection updates the Study, Study Country, and Site in EDC with data from CTMS.

You can also perform these steps with Vault Loader in EDC.

If Subject, Subject Visit, and Visit Definition exist in CTMS, but do not exist in EDC:

This is not a valid case for this connection. You can pull in this information from an external EDC system.

If Subject, Subject Visit, and Visit Definition exist in both CTMS and EDC:

  • Ensure the Study, Study Country, and Site are connected to CTMS per the configuration instructions.
  • 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 connection updates the Subject, Subject Visit, and Visit Definitions in CTMS with data from EDC.

You can also perform these steps with Vault Loader in CTMS.

If Subject, Subject Visit, and Visit Definition do not exist in either CTMS or EDC:

  • Ensure the Study, Study Country, and Site are connected to CTMS per the configuration instructions.
  • Set the Connect to Vault CDMS field on the Study record in CTMS to Yes.
  • The connection updates the Subject, Subject Visit, and Visit Definitions in CTMS with data from EDC.

In addition to the above steps, you should also choose the desired connection in the Study record’s CDMS Connection field.

Connecting a New Study

To connect new studies in EDC to CTMS:

  1. In the CTMS Vault, create the Study record and ensure that the Connect to Vault CDMS field is set to No.
  2. In the EDC Vault, create the Production Study Instance record and ensure that the Connect to Vault CDMS field is set to Yes.
  3. Take the Global ID from the Study record in CTMS and copy its value to the Link field on that Product Study Instance record in EDC.
  4. In the CTMS Vault, change the Connect to Vault CDMS field to Yes.

Connecting Arms and Cohorts

You can enable transferring data about Subject Arms, Cohorts, or both in your connection, depending on business needs. Some additional configuration is required for each arm or cohort you wish to connect:

  1. In the CTMS Vault, navigate to your connection and activate the Field Rule for the Arm or Cohort object, or both.
  2. In CDMS, locate the name of the arm or cohort you wish to connect to.
  3. In CTMS, locate the Arm or Cohort object record you wish to link. Enter the CDMS name into the link__sys field on the record.

Deactivating the Field Rule for Arms or Cohorts does not remove the links; the connection merely ignores them during the data exchange.

Connecting a New Site

When you create new sites in the CTMS Vault, Vault automatically creates them in the EDC Vault. However, you must complete the following steps for each site in the EDC Vault:

  1. In the EDC Vault, navigate to Tools > EDC Tools and select the study.
  2. Navigate to the Sites tab and click on the Site Number that you want to activate.
  3. Enter your site’s Principal Investigator.
  4. Enter an Active Version and click Save.

Configuring Integration Points

Configuring the Protocol Deviations Integration Point

You can configure your CTMS Vault to receive protocol deviation data from an EDC Vault for connected studies. When this feature is enabled, Vault transfers Protocol Deviation types of Issues (pdv__ctms) from EDC.

To enable this feature, you need to activate the Content (blinding__v) field on the Issues (pdv__ctms) Object. To do this, navigate to Admin > Settings > Configuration and click Object Configuration. Select the Issues Object and navigate to the Fields tab. Then, edit the Content (blinding__v) field to set the field to ‘Active’ and click Save.

Once the field is enabled, activate the Protocol Deviation integration:

  1. Navigate to Admin > Connections > CDMS/Clinical Operations Connection.
  2. Find the Protocol Deviation integration in the Integrations section.
  3. From the Actions menu for the Protocol Deviation integration, select Activate.

Configuring Procedures

In CTMS Vaults with Vault Payments you can configure Vault to receive Procedures when records are generated and updated in EDC for a connected study. Note that for Vault to transfer Procedures, the Names of the Procedure Definitions must be identical in both Vaults.

First, you must activate the values for the Procedure Status picklist:

  1. Navigate to Admin > Settings > Application Settings and click Edit.
  2. In the CTMS Features section, set the Enable Procedure Status Standard Picklist Values checkbox.
  3. Click Save.

We recommend reviewing any existing custom procedure definition picklist values in your Vault and setting them to inactive.

After you enable the Procedure Status picklist values, activate the Procedures integration:

  1. Navigate to Admin > Connections > CDMS/Clinical Operations Connection.
  2. Find the Procedures integration in the Integrations section.
  3. From the Actions menu for the Procedures integration, select Activate.

Once the integration is activated, Vault will transfer new Procedure records and updates to existing Procedures from EDC to CTMS.

Configuring Repeating Visits

You can configure your CTMS Vault to receive repeating visit information from EDC. To enable this feature, navigate to Admin > Settings > Application Settings and click Edit. In the CTMS Features section, set the Enable CDMS & Clinical Operations Repeating Visits Integration checkbox, and click Save.

Once enabled, add the following fields to the relevant objects, page layouts, and reports:

  • Visit Name (Repeat Visit Name in EDC)
  • Visit Label (Override Label in EDC)
  • Repeating Visit (Repeat Visit Definitions in EDC)

If your Vault includes the Vault Payments add-on product, Payable Items are generated based on the shared Visit Definition for each Subject Visit.

Configuring SDV Requiredness

You can configure your CTMS Vault to receive SDV requiredness data from EDC. When this feature is enabled, Vault transfers the value of the SDV Mode field from EDC when the event is required.

To enable this feature, navigate to Admin > Settings > Application Settings and click Edit. In the CTMS Features section, set the Enable CDMS & Clinical Operations SDV Requiredness Integration checkbox and click Save.

Deleted Item Marking

When users delete Event, Subject, Procedure, and Protocol Deviation records in CDMS, the Clinical Operations to CDMS Connection can automatically mark these records as deleted in the CTMS Vault. This ensures both Vaults contain the most up to date information.

This setting is enabled by default for new customers whose Clinical Operations Vault is based on the Clinical Operations template. If you are not sure if this applies to your Vault, please contact Vault Support. Customers with existing Clinical Operations Vaults must contact Vault Support to enable the setting. Though not recommended, you can also contact Vault Support to disable Deleted Item Marking setting if needed.

Field Updates for Deleted Items

After the Connection finds a deletion in CDMS, records in the CTMS Vault are updated as follows:

Subject (subject__clin)

Field Label Field Name Value After Deletion Comments
Link link__sys Blank  
Subject Status subject_status_clin “Deleted in CDMS” New picklist value: deleted_in_cdms__v
End of Study Date end_of_study_date__v Blank  
End of Treatment Date end_of_treatment_date__v Blank  
Enrolled Date enrolled_date__v Blank  
Randomized Date randomized_date__v Blank  
Screen Failed Date screen_failed_date__v Blank  
Screened Date screened_date__v Blank  
Withdrawn Date withrawn_date__v Blank  
Casebook Link casebook_link__c Blank Custom field which may not exist in all Vaults. Blanking link__sys will cause this field to be blank.

Subject Visit (visit__v)

Field Label Field Name Value After Deletion Comments
Link link__sys Blank  
Visit Status visit_status__v “Deleted in CDMS” New picklist value: deleted_in_cdms__v
SDV Complete Date sdv_date__v Blank  
SDV Mode sdv_mode__v Blank  
Review for DMR rev_dmr__v Blank  
DMR Complete Date dmr_date__v Blank  

Procedure (procedure__v)

Field Label Field Name Value After Deletion Comments
Link link__sys Blank  
Procedure Status procedure_status__v “Deleted in CDMS” New picklist value: deleted_in_cdms__v
Procedure Date procedure_date__v Blank  

Protocol Deviation (pdv_ctms)

Field Label Field Name Value After Deletion Comments
Link link__sys Blank  
Protocol Deviation Status pdv_cdms_status__v “Deleted in CDMS” New picklist value: deleted_in_cdms__v

Connecting a New CDMS Vault

Once you have successfully established a CDMS Vault connection, you can easily connect a new one by copying the existing connection. To connect another CDMS Vault after the first:

  1. From your existing connection record’s actions menu, select Copy to new to create a new connection record that copies the existing one.
  2. Activate the connection.
  3. Update the CDMS Connection field of any connected studies, including your currently connected studies, with the new connection’s value.
  4. Connect the new studies.

Refreshing and Reprocessing

There are several ways to refresh the connection between the CTMS and EDC Vaults after the initial configuration.

Single Study Refresh

Should you find a single Study’s data to be out of sync, contact Vault Support and have them perform a refresh on that Study.

Reprocess Request

The Reprocess Request action triggers the CTMS Vault to pull data from the EDC Vault as if a change had been made in the EDC Vault. This may be necessary if you fixed an issue with the User Exception Message or User Exception Item objects and want to verify the fix. To reprocess the data:

  1. In the CTMS Vault, navigate to Admin > Connections > User Exception Messages.
  2. Open the User Exception Message that you want to reprocess.
  3. Select Reprocess Request from the Actions menu.

User Exception Messages

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 Clinical Operations to CDMS Vault Connection. If either Vault is unable to process incoming data, Vault creates a User Exception Message record to capture the failure and individual User Exception Item records for each item that failed.

User Exception Message Error Types

All User Exception Messages contain references to the applicable Integration and Integration Point. Some error types that you may see are:

Error Type Description
CONNECTION_ERROR There is a connection error between the Vaults. This may occur if your Vault is in maintenance mode.
MESSAGE_PROCESSING_ERROR There are issues delivering the Spark Message or with the query or API that is being called. This may occur if additional Field Rules were manually created or if a Field Rule that is required for the data transfer is Inactive.
ITEM_PROCESSING_ERROR There are issues creating records in the target Vault. This may occur if there are missing reference lookups, missing required information, missing mapped data, or permission issues.

User Exception Item Error Types

All User Exception Items contain a reference to the applicable User Exception Message, the Item field containing the Global ID from the source of the record that failed to be created, and the Item Data field containing the actual data used to create the record. Some error types that you may see are:

Error Type Description
INVALID_DATA A record failed due to incorrect data or a reference cannot be resolved via the self-referencing query.
ITEM_NOT_FOUND A field can’t be found because a custom Field Rule was added.
OPERATION_NOT_ALLOWED The record was not created due to a permission issue.
REFERENCE_NOT_FOUND A Reference Lookup for a record can’t be resolved.

You need a System Admin security profile as well as the following permissions to set up the standard Clinical Operations to CDMS connection:

Permission Type Permission Effect
Security Profile Admin: Application: Manage Connections Ability to access the Connections tab in Admin and activate the Connections
Security Profile Object: User Exception Item, User Exception Message: Read Ability to see User Exception Item and User Exception Message records if a connection failure occurs