# About the Clinical Operations-EDC Connection Using the Clinical Operations-EDC Connection, organizations with both a Clinical Operations CTMS or eTMF Vault and an EDC Vault can exchange data in near-real time. The Clinical Operations-EDC Connection exchanges the following data: **From Clinical Operations 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 Clinical Operations target Vault**: | Label in EDC Source Vault | Label in Clinical Operations Target Vault | |---|---| | _Events_ | _Subject Visits_ | | _Event Definitions_ | _Visit Definitions_ | | _Procedures_ | _Procedures_ (Requires Payments) | | _Procedure Definitions_ | _Procedure Definitions_ (Requires Payments) | | _Subjects_ | _Subjects_ | | _Protocol Deviations_ | _Protocol Deviation_ types of Issues (`pdv__ctms`) | | _Closeout CRFs_ | _Site Closeout PDF_ (`site_closeout_pdf__v`) | 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 Clinical Operations, 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 Clinical Operations 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 Clinical Operations. * 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 Clinical Operations as you create or update those records in EDC. It also updates the _Visit Method_ field on the _Subject_ object. In Clinical Operations Vaults with the Payments add-on product, Vault also creates or updates _Procedures_ and _Procedure Definitions_. * For _Studies_ in Clinical Operations with the _Connect to Vault CDMS_ set to **Yes** and that include _Subject_ records, Vault attempts to link _Subjects_ in Clinical Operations 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 Clinical Operations. This can be useful, for example, if your organization tracks _Subjects_ for prescreening purposes in Clinical Operations before they are enrolled in EDC.

Note: When Subjects transfer to a new Site, EDC and Clinical Operations Vaults display corresponding records differently. In EDC Vaults, the related Subject Visit, Procedure, and Protocol Deviation records update the Site value to the new site and populate the Originating Site field with the original site where the Subject Visit occurred. In Clinical Operations Vaults, Subject Visit, Procedure, and Protocol Deviation records that happen prior to the Subject transfer remain unchanged and keep the original Site value. Any Subject Visit, Procedure, and Protocol Deviation records created after the Subject transfer will be associated with the new site.

## Creating a New Study with the Clinical Operations-EDC Connection The connection requires that you create the _Study_ record in each Vault: 1. In the Clinical Operations 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. 2. 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**. 3. In the Clinical Operations Vault, set the created _Study_'s _Connect to Vault CDMS_ field value to **Yes**.

Note: Record creation via a Veeva Connection does not validate the CDMS Object uniqueness configuration.

## Pausing the Clinical Operations-EDC Connection for Individual Studies If needed, you can pause the Clinical Operations-EDC 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-EDC Connection integrations for the _Study_ on both Vaults are paused, including deletions. In the Clinical Operations and EDC 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-EDC 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-EDC Connection for a _Study_: 1. In your Clinical Operations Vault, locate the _Study_ you wish to pause. 2. From the All Actions Menu, click **Pause Connected Study**. 3. Vault displays a message to confirm you are pausing the _Study_. Click **Yes** to confirm. Click **No** to return to the previous view.