Using the Clinical Operations - EDC Connection, organizations with both a Clinical Operations CTMS Vault and a CDMS EDC Vault can exchange data in near-real time.
The Clinical Operations - EDC Connection exchanges the following data:
From CTMS source Vault to EDC target Vault:
- Studies (Updates only, creation of the Study is still manual in EDC)
- Study Countries
- Study Sites
From EDC source Vault to CTMS target Vault:
| Label in EDC Source Vault | Label in CTMS Target Vault |
|---|---|
| Events | Subject Visits |
| Event Definitions | Visit Definitions |
| Procedures | Procedures (Requires Vault Payments) |
| Subjects | Subjects |
| Protocol Deviations | Protocol Deviation types of Issues (pdv__ctms) |
The connection also updates the Visit Method field on the Subject object.
To use the Clinical Operations - EDC Connection, an Admin must complete several configuration steps and activate the connection.
How the Clinical Operations - EDC Connection Works
The Clinical Operations - EDC Connection enables Vault to create and update records in a connected Vault after a user makes a change to an affected record in the source Vault. Once an Admin activates the connection between EDC and CTMS, record data begins flowing between the Vaults based on the Connect to Vault CDMS and Connect to Clinical Operations fields on the Study object:
- For Studies in CTMS with the Connect to Vault CDMS field set to Yes, Vault updates existing Study records and creates or updates Study Countries and Sites in EDC as you create or update those records in CTMS.
- For Studies in EDC with the Connect to Vault Clinical Operations field set to Yes, Vault creates or updates Subjects, Subject Visits, Visit Definitions, and Protocol Deviation types of Issues in CTMS as you create or update those records in EDC. It also updates the Visit Method field on the Subject object. In CTMS Vaults with the Vault Payments add-on product, Vault also creates or updates Procedures.
- For Studies in CTMS with the Connect to Vault CDMS set to Yes and that include Subject records, Vault attempts to link Subjects in CTMS to Subjects in EDC using the External (RTSM) ID field if the two Subject records are not yet linked by the Global ID. Once the Subject Records are linked, Subject information flows from EDC to CTMS. This can be useful, for example, if your organization tracks Subjects for pre-screening purposes in CTMS before they are enrolled in EDC.
Creating a New Study with the Clinical Operations - EDC Connection
The connection requires that you create the Study record in each Vault:
- In the CTMS Vault, create a Study record and set the Connect to Vault CDMS field to No on the Study record details page. Then, copy the Global ID field value from the study.
- In the EDC Vault, create a Study record and paste the Global ID value from the previous step to its Link field value. Set the Connect to Vault Clinical Operations field to Yes.
- In the CTMS Vault, set the created Study’s Connect to Vault CDMS field value to Yes.
Pausing the Clinical Operations to CDMS Connection for Individual Studies
If needed, you can pause the Clinical Operations to CDMS Connection at the individual Study level. When you pause the connection for a Study, the connection does not create, update or delete any data for that Study in either Vault. All the Clinical Operations to CDMS Connection integrations for the Study on both Vaults are paused, including deletions. In the Clinical Operations and CDMS Vaults, the Study is still active for data entry, payments, monitoring, and other functionality-only the connection is paused. Other connected studies continue to flow as usual, including updating their last successful run time.
When you are ready, you can resume the connection for the Study. Once you resume, the connection picks up the data for that Study since the last time the connection successfully ran, including any deletions.
In general, it is best to pause the Clinical Operations to CDMS Connection for relatively short periods of time (up to a few weeks). If you need to pause the connection for a longer time, consider disconnecting the Study and reconnecting when you want the connection to resume.
You can see whether a Study was paused or resumed from the Study CDMS Connectivity related object record.
To pause the Clinical Operations to CDMS Connection for a Study:
- In your Clinical Operations Vault, locate the Study you wish to pause.
- From the All Actions Menu, click Pause Connected Study.
- Vault displays a message to confirm you are pausing the Study. Click Yes to confirm. Click No to return to the previous view.