Integration support for the Enrollment visit type

Select integrations have been updated to support the transfer of subject enrollment data to downstream systems for studies that use the Enrollment visit type.

Studies can include an Enrollment visit that, when completed, triggers the enrollment event. The enrollment event invokes the appropriate integration to send subject enrollment data to downstream systems. Previously, the enrollment event was triggered only when the first visit after the Screening visit was completed. Study designers can now choose either approach.

Note:

For more information, see New enrollment visit type.

For information about the following integrations, see the Digital Gateway User Guide after the assessment environment upgrade.

Integration Details
Oracle Siebel CTMS Study Version Template (SVT)
  • If an Enrollment visit is included in a study version, the integration sends it to CTMS, where CTMS creates a corresponding template.
  • To support this feature, add the Enrollment visit to the VisitType codelist section in the integration configuration file. Reach out to your Oracle point of contact to request the configuration update.
Oracle Siebel CTMS Subject Visit (SV)
  • After the Enrollment visit is completed in Clinical One Cloud Service, the integration updates the subject status to Enrolled, populates the Subject Status Date field with the enrollment date from Clinical One Cloud Service, and sets the visit status to Complete in CTMS.
  • If you undo enrollment, the integration reverts the subject status to Screened and the Enrollment visit status to Incomplete in CTMS to match the subject and visit status in Clinical One Cloud Service.
  • The existing enrollment template (SubjectEnrollmentIntegration_CTMS_SV_Std.xml) supports Enrollment visit events.
Multi-IWR
  • IWR vendors can trigger the enrollment action by using the REST API POST call. For more information, see About the external REST API call.

    Note: User-entered enrollment dates and edits to enrollment dates are not supported.

  • To support this feature, an integration configuration update is needed. Reach out to your Oracle point of contact to request the configuration update.
SAP Actual Enrollment
  • This integration generates a cumulative extract that includes completed visits and the number of subjects who completed each visit.
  • If your study includes an Enrollment visit, the extract includes both the Enrollment visit and the Enrollment visit date from Clinical One Cloud Service.
  • Configuration changes are not required to support this feature.