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:
- Configure a View Set Definition with the appropriate View Definitions to export subject milestone data.
- Create a Connection between your EDC vault, your FTP server, and your CTMS vault from EDC Tools > Connections.
- 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.
Study, Study Country, and Study Site record data is not pushed from your EDC vault to your CTMS vault. You must populate these records within both CTMS and EDC.
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.
- Configure a View Set Definition with the appropriate View Definitions to export subject milestone data.
- Create a Connection between your EDC vault, your FTP server, and your CTMS vault from EDC Tools > Connections.
- 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.
Related Permissions
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 EventObject: 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.