About the Clinical Operations - EDC Connection

With the Clinical Operations - EDC Connection , you can easily leverage data from your EDC vault for operational reporting within your Clinical Operations (CTMS or eTMF) vault. For example, you can report on subject statuses and status dates captured in Veeva EDC, as well as navigate from a Subject within Veeva CTMS to a subject’s Casebook in Veeva EDC. Once configured, the connection shares data automatically, eliminating manual exports and imports.

This feature is only available to organizations with both Clinical Operations and EDC vaults.

Transferring Closeout PDFs

With the Clinical Operations - EDC Connection, any Closeout PDFs you generate are automatically sent to eTMF if the following conditions are met:

  • The Clinical Operations - EDC connection is active.
  • The study is connected to Clinical Operations.
  • The CDMS to CTMS Site Closeout PDF Data integration is active (this integration is active by default).
  • Your organization is using eTMF.

If these conditions are met, every time you generate Closeout PDFs for a site, a new version of the PDFs is generated and sent to eTMF. This process is automatic, and there are no additional steps to be performed on your end.

Exporting Subject Milestone Data

You can define subject milestone exports in Veeva EDC that update subject information in an associated Clinical Operations vault for operational reporting. This feature ensures you easily keep concurrent milestone data for your subjects across both vaults.

This export contains the following fields:

  • Study
  • Country
  • Site
  • Subject ID
  • Subject Status
  • Screened Date
  • Screen Failed Date
  • Randomized Date
  • Enrolled Date
  • Withdrawn Date
  • End of Treatment Date
  • End of Study Date

Transferring Visit Cycles for Payments

The connection supports visit cycles for payments by transferring Event Group and Event Label definitions and sequences from EDC to CTMS. This feature eliminates the manual data entry step for repeating visits and automatically links the following data to CTMS Payments:

  • Event Group and Event Label definitions
  • Visit sequences
  • Repeating visit override labels

Connecting Vaults

We’ve retired all FTP content for the Clinical Operations - EDC Connection. If you require additional information about this change, reach out to Veeva Support.

You can connect your Clinical Operations vault to your EDC vault via the Integration feature. To integrate, the feature must be enabled in your EDC vault. When integrated, Veeva EDC and Veeva Clinical Operations can automatically exchange record data in near-real time.

For example, whenever a data entry user creates a new Subject in EDC (by creating a new Casebook in the Data Entry tab), Clinical Operations automatically creates a new, matching Subject in the Clinical Operations vault.

The connection also directly retrieves Event review status roll up calculations for SDV and DMR from Event Operational Summary records in EDC, including data for log events.

For a breakdown of all data exchanged, see the Integrations Chart in the Clinical Operations Help.

Setting Study Object Fields

The EDC/Clinical Operations 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 where the Connect to Vault CDMS field is set to Yes, Vault creates or updates records in EDC as you create or update those records in Clinical Operations. Similarly for Studies in EDC where the Connect to Vault Clinical Operations field is set to Yes, Vault creates or updates records in Clinical Operations as you create or update those records in EDC.

Note, the connection only updates Studies. It cannot create Study records.

Object Uniqueness: Veeva EDC has site uniqueness requirements that differ from Clinical Operations. Creating records through the Connection can bypass an object’s uniqueness configuration in EDC. When a record is created manually through the UI, the object’s uniqueness still applies.

See Configuration for the EDC/Clinical Operations Connection for configuration instructions.

Actions within Veeva Clinical Operations

When configured, users with access to both EDC and Clinical Operations vaults can open a Subject’s casebook in EDC directly from their Clinical Operations vaults. What actions those users can perform in EDC depends on their 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.