About the eCOA-Clinical Operations Connection

With the eCOA-Clinical Operations Connection, organizations with both an eCOA Vault and Clinical Operations Vault can exchange data and documents in near-real time. The eCOA-Clinical Operations Connection exchanges the following data.

Data created and updated in the Clinical Operations Vault and sent to the eCOA Vault:

  • Studies
  • Study Countries
  • Study Sites

Documents created and updated as CrossLinks from the eCOA source Vault to Clinical Operations target Vault:

  • Study Design Specification
  • End-of-Study Participant Reports (Final Subject Data in Clinical Operations)

To use the eCOA-Clinical Operations Connection, an Admin must complete configuration steps and activate the connection.

How the eCOA-Clinical Operations Connection Works

For Studies in Clinical Operations with the Connect to Vault eCOA field set to Yes, Vault creates new records or updates existing records in the following scenarios:

  • When a user creates or edits a Study record, Vault creates or updates the Study record in the eCOA Vault.
  • When a user creates or edits a Study Country record in the Clinical Operations Vault, Vault creates or updates the Study Country record in the eCOA Vault.
  • When a user creates or edits a Study Site record in the Clinical Operations Vault, Vault creates or updates the Study Site record in the eCOA Vault.
  • When the system generates a Study Design Specification in the eCOA Vault, Vault creates or updates a CrossLink in the Clinical Operations Vault.
  • When the system generates an End-of-Study Participant Report in the eCOA Vault, Vault creates or updates a CrossLink in the Clinical Operations Vault.

About Record Creation & Update

When creating a record through the connection, Vault also populates the Link (link__sys) field on the target record with the source record’s Global ID (global_id__sys). These fields let Vault know which records to update in the target Vault when you update data in the source Vault.

The following fields are transferred:

  • Study object
    • Study Number as Study Number
    • Lifecycle State as Clinical Operations Study Status
  • Study Country object
    • Study Number as Study Number
    • Country as Country
    • Study Country Name as Study Country Name
  • Study Site object
    • Study Country as Study Country
    • Study Site Number as Study Site Number
    • Site Name as Site Name
    • Site Timezone as Site Timezone
    • Lifecycle State as Clinical Operations Site Status
  • eCOA End-of-Study Participant Report documents
    • Name as Document Name 
    • Title as Document Title
    • Study as Study
    • Study Country as Study Country
    • Study Site as Study Site
    • Content as Content
    • Global ID as Source Link
    • Major Version as Major Version
    • Minor Version as Minor Version
  • eCOA Study Design Specification documents
    • Name as Document Name
    • Title as Document Title
    • Study as Study
    • Content as Content
    • Global ID as Source Link
    • Major Version as Major Version
    • Minor Version as Minor Version