Note: While the FTP connection described in this article continues to function, we have introduced a CDMS and Clinical Operations Vault Connection using Spark messaging as the recommended path to transfer record data.
The EDC to CTMS FTP connection feature provides a cross-domain connection between your EDC and CTMS Vaults. You can leverage EDC data while working in your CTMS Vault by reporting on Subject statuses and status dates captured within EDC. This connection also allows you to navigate to and work with a Subject’s casebook in EDC from the Subject or Monitored Subject record in CTMS.
Note: This feature is only available to organizations with both CTMS and EDC Vaults.
eHow the FTP Connection Works
With this connection, Vault EDC extracts Subject statuses and status dates in a CSV, connects to your CTMS Vault, and places the extracted CSV into a configured folder on the FTP. Vault CTMS then ingests the CSV and creates new Subject records or updates records accordingly. Data syncing happens automatically, with your EDC Vault “pushing” updates to your CTMS Vault daily.
Note: Entering Subject data in your CTMS Vault does not update related fields in EDC Vaults.
Using Data Record Syncing
About the EDC ID Field
The EDC ID field is a unique identifier that allows Vault EDC to connect a Subject with the correct Site and push data to your CTMS Vault. This field is available on the following objects:
- Study Country
- Study Site
- Monitored Subject
- Subject Visit
- Monitored Subject Visit
- Visit Definition
- Study Arm
Populating the EDC ID Field
For the connection to work correctly, the EDC ID field in your CTMS Vault must match the Study, Study Country, and Study Site record names in your EDC 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.
Vault populates the EDC ID field based on the name you enter when you create Study, Study Country, and Study Site records in CTMS. For example, if you created a Study record with the name
Study-0123, the EDC ID field would default to
Study-0123. If you then created a Study Country record from the Study record with the name
United States, the EDC ID field would be:
The table below illustrates how Vault populates the EDC ID field:
|Object||Study||Study Country||Study Site||CTMS EDC ID|
|Study Country||Study-0123||United States||
|Study Site||Study-0123||United States||001||
|Study Site||Study-0123||United States||002||
If a Study, Study Country, or Study Site already exists in your EDC Vault and has a different name, you’ll need to update the EDC ID field manually to reference the correct EDC record name. For example, if the EDC ID field on your Study Site record is
Study-0123|United States|001 but the Study record name in your EDC Vault is
STUDY 123, you would update the EDC ID field on the Study Site record in your CTMS Vault to:
STUDY 123|United States|001. You’d also need to update the EDC ID field on the related Study and Study Country records to reference
STUDY 123. You can update this field manually or via the Vault Loader.
Note: Vault does not push Study, Study Country, and Study Site record data from your EDC Vault to your CTMS Vault. You must populate these records within both CTMS and EDC.
Subjects & Subject Statuses
Using this connection, you can update a Subject’s current status and the date the Subject entered that status in your EDC Vault, and view this data from your CTMS Vault.
In your CTMS Vault, you can see the following integrated dates and data for Subject records:
- Study, Study Country, and Study Site
- Screened Date
- Screen Failed Date
- Enrolled Date
- Randomized Date
- Withdrawn Date
- End of Treatment Date
- Complete Date
- EDC ID
- Subject ID
- Subject Status
Opening a Casebook
When configured, cross-domain users with access to both EDC and CTMS Vaults can open a Subject’s casebook in EDC directly from their CTMS Vaults. Navigate to a Subject or Monitored Subject record and select Open Casebook from the Actions menu. Vault opens the related Casebook record within EDC.
What actions you can perform in EDC depends on your permissions. For example, a CRA could navigate to a casebook and perform source data verification (SDV) in their EDC Vault, while a Data Manager might open a casebook to create a query. For more information about working in EDC, see the EDC Help Documentation.
The following permissions allow you to work with data integrated across your CTMS and EDC Vaults:
|Security Profile||Objects: Subject: Edit||
Ability to view integrated EDC date and perform the Open Casebook action from a Subject record; note that users must also be cross-domain users with an EDC Vault.
|Security Profile||Objects: Monitored Subject: Edit||
Ability to view integrated EDC date and perform the Open Casebook action from a Monitored Subject record; note that users must also be cross-domain users with an EDC Vault.