Configuration for the EDC/CTMS FTP Connection


There are three main tasks you must complete in your EDC vault before using this EDC/CTMS integration:

  1. Configure a View Set Definition with the appropriate View Definitions to export subject milestone data.
  2. Create a Connection between your EDC vault, your FTP server, and your CTMS vault from EDC Tools > Connections.
  3. Schedule a Data Export job to export the data using the configured View Set Definition and Connection.

See details for each task in the following sections.

Prerequisites

You must already have created your Study, Study Countries, and Study Sites before using this feature. Provide the verbatim Name value for each of those records to the person responsible for creating the equivalent records in the CTMS vault. That person will fill the EDC ID field on each record with the corresponding Name from the EDC vault, if those records already exist, or they will create records with the matching Names.

About the EDC ID Field

The following objects in Vault CTMS use the EDC ID field to integrate with Vault EDC. Each of these EDC ID values must match the Name of the equivalent record in Vault EDC. Vault EDC and Vault CTMS’s Clinical Vault Loader use this field as an identifier when creating and updating Subject records.

  • Study
  • Study Country
  • Study Site
  • Subject
  • Monitored Subject

For the connection to work correctly, the Study, Study Country, and Study Site record names in your EDC vault must match the EDC ID field in your CTMS vault. We recommend creating Study, Study Country, and Study Site records with the same names in both your EDC and CTMS vaults to ensure correct data.

The table below illustrates how Vault populates the EDC ID field in CTMS vaults:

Object Study Study Country Study Site CTMS EDC ID    
Study Study-0123     Study-0123    
Study Country Study-0123 United States   Study-0123 United States  
Study Country Study-0123 Canada   Study-0123 Canada  
Study Site Study-0123 United States 001 Study-0123 United States 001
Study Site Study-0123 United States 002 Study-0123 United States 002
Study Site Study-0123 Canada 003 Study-0123 Canada 003

Connection Configurations

There are three main tasks you must complete in your EDC vault before using this feature.

  1. Configure a View Set Definition with the appropriate View Definitions to export subject milestone data.
  2. Create a Connection between your EDC vault, your FTP server, and your CTMS vault from EDC Tools > Connections.
  3. Schedule a Data Export job to export the data using the configured View Set Definition and Connection.

See details for each task in the following sections.

When you create your FTP Connection, you will need to enter the Username and Password of a connection user in the CTMS vault. The CTMS user who performs connection tasks must not have the Vault Owner security profile.

Configuring the View Set Definition

You must create at least one View Set Definition and one View Definition to use the connection. The View Definition must contain the following mappings to correctly update data in Vault CTMS. See these instructions about creating views.

Choose the Export Set Type. Name your View Set Definition “subject_clin.edc_id__v” and your View Definition “subject_clin.edc_id__v.csv”.

Column Definition Name Order Binding Type Column Binding
study_clin.edc_id__v 1 Direct Object: Study (study__v)
Study Country 2 Direct Object: Study Country (study_country__v)
Value: Name (name__v)
study_country__v.edc_id__v 3 Derived Formula: 
concatenate({study__clin.edc_id__v}, “ | “, {Study Country})
Site 4 Direct Object: Site (site__v)
Value: Name (name__v)
site__v.edc_id__v 5 Derived Formula:
concatenate({study__clin.edc_id__v}, “ | “, {Site})
name__v 6 Direct Object: Subject (subject__v)
Field: Name (name__v)
Subject Status 7 Direct Object: Subject (subject__v)
Value: Subject Status (subject_status__v)
subject_status__v 8 Derived Formula:
if(or(textEquals({Subject Status}, "enrolled__v"), textEquals({Subject Status}, "screen_failure__v"), textEquals({Subject Status}, "in_screening__v"), textEquals({Subject Status}, "withdrawn__v"), textEquals({Subject Status}, "complete__v"), textEquals({Subject Status}, "enrolled__v")), substitute({Subject Status}, "__v", "__clin"), if(textEquals({Subject Status}, “pre_screen__v”), “pre_screening”, trim({Subject Status})))
screened_date__v 9 Direct Object Identifier: {Event/Form/Item Group/Item}
* Identify a Date-type Item in your Off Treatment-type Event
Object: Item (item__v)
Value: Value Normalized (value_normalized__v)
Screen Failed Date 10 Derived Object Identifier: {Event/Form/Item Group/Item}
* Identify an Item in your Screened-type Event
Object: Item (item__v)
Value: Event Date (event__vr.event_date__v)
* Date of the Event as related to the Item
screen_failed_date__v 11 Direct Formula:
`text(dateInISO({Screen Failed Date}, "yyyy-mm-dd"), "dd-mmm-yyyy")`
randomized_date__v 12 Direct Object Identifier: {Event/Form/Item Group/Item}
* Identify a Date-type Item in your randomization Event
Object: Item (item__v)
Value: Value Normalized (`value_normalized__v)
enrolled_date__v 13 Direct Object Identifier: {Event/Form/Item Group/Item}
* Identify a Date-type Item in your Enrollment-type Event>
Object: Item (item__v)
Value: Value Normalized (value_normalized__v)
Withdrawn Date 14 Derived Object Identifier: {Event/Form/Item Group/Item}
* Identify an Item in your withdrawn Event
Object: Item (item__v)
Value: event__vr.event_date__v
* Date of the Event as related to the Item
withdrawn_date__v 15 Direct Formula:
text(dateInISO({Withdrawn Date}, "yyyy-mm-dd"), "dd-mmm-yyyy")
end_of_treatment_date__v 16 Direct Object Identifier: {Event/Form/Item Group/Item}
* Identify a Date-type Item in your Off Treatment-type Event
Object: Item (item__v)
Value: Value Normalized (value_normalized__v)
End of Study Date 17 Direct Object Identifier: {Event/Form/Item Group/Item}
* Identify an Item within your Off Study-type Event
Object: Item (item__v)
Value: event__vr.event_date__v
* Date of the Event as related to the Item
end_of_study_date__v 18 Derived Formula:
text(dateInISO({End of Study Date}, "yyyy-mm-dd"), "dd-mmm-yyyy")
edc_id__v 19 Direct Object: Subject (subject__v)
Value: External ID (external_id__v)

Connecting to the FTP Server

To use the Vault EDC & CTMS connection, you must create a Connection between your EDC vault, your FTP server, and your CTMS vault. Use the Veeva Vault Connection Type and enter the information for your vault’s FTP server.

For details about creating a new FTP connection, see Connecting to an FTP Server from EDC Tools.

Scheduling the Job

Lastly, you must configure a recurring, scheduled job to export your subject data from Vault EDC. Navigate to EDC Tools > Jobs > Scheduled Jobs and create a new Data Export job with the recommended configuration below:

Field Recommended Value
Type Data Export
View Set Select the View Set Definition that you configured for use with this connection
Export File Type CSV
External Connection Select the Connection you created to your vault’s FTP server & CTMS vault.
Include Merged View No. Do not select the Include Merged View checkbox.
Frequency Daily
Name Provide a descriptive name that indicates that this is for the Veeva CTMS connection
Run at Work with an Admin of the integrated CTMS vault to select a time.

Ad Hoc Runs

If needed, you can choose to run the Data Export job for the connection on an ad hoc basis, in addition to scheduled instances.

Navigate to the Job from EDC Tools > Jobs > Scheduled Jobs and select Run Now from the job’s Actions menu.