Enhancements to Oracle Siebel CTMS integrations

Updates include additional support for integrating screening and enrollment dates, undoing subject enrollment, and integrating email addresses associated with site accounts.

Oracle Siebel CTMS Subject Visit Integration: Additional Support for Screening and Enrollment dates

Starting in Clinical One Cloud Service 26.2, after selecting Screen, users are presented with a dialog box where they can accept the default screening date (today's date) or, if applicable, select a different screening date. Users can also edit screening and enrollment dates after event completion. For more information about this enhancement, see Enhancements to screening and enrollment management.

The Oracle Siebel CTMS Subject Visit (SV) Integration has been enhanced to support these new capabilities. Additional details will be available in the Digital Gateway User Guide after the assessment environment upgrade is complete.

Key details:
  • After screening is complete, Clinical One Cloud Service sends the default screening date (today's date) or user-entered screening date to CTMS. The screening date populates the Encounter Date and Status Date fields in CTMS if the screening visit is the first visit in the study design.
  • Edits to screening and enrollment dates made using the Edit Screened and Edit Enrolled options available from the Manage drop-down menu on the Subjects page are sent to the CTMS Status Date field after the event is completed.
  • Modifying the screening or enrollment date for a subject whose status has progressed beyond Screened or Enrolled (for example, Withdrawn or Completed) does not change the subject status or associated dates in CTMS. This behavior preserves subject status history while allowing corrections to the screening or enrollment date.

Integration template updates:

A new integration template must be adopted to support the following use cases. Reach out to your Oracle point of contact to implement the new template.
  • To support integration of the default or user-selected screening date with the Status Date field in CTMS.
  • To support integration of edited screening and enrollment dates with the CTMS Status Date field.

If the new template is not adopted, the system date is integrated instead in both scenarios.

Oracle Siebel CTMS Subject Visit Integration: Support for Undo Subject Enrollment

Starting in Clinical One Cloud Service 26.2, users can undo subject enrollment to revert the subject status to Screened, allowing the subject to be screen failed. For more information about this enhancement , see Enhancements to screening and enrollment management.

The Oracle Siebel CTMS Subject Visit (SV) integration has been enhanced to support this new capability.

Key details:
  • When subject enrollment is undone, the subject’s status is updated to Screened in Clinical One Cloud Service and sent to CTMS along with the event date, which is mapped to the subject’s Status Date field.
  • Subsequent subject status updates (for example, Screen Fail) continue to integrate as expected.

Integration template updates

A new integration template must be adopted to support the following use case. Reach out to your Oracle point of contact to implement the new template.
  • To support integration of the undo enrollment event details with CTMS, you must adopt the updated integration template. If the template is not adopted, the undo enrollment event is not integrated with CTMS, and the status does not revert from Enrolled to Screened.

Oracle Siebel CTMS Site Integration: Email address mapping to Clinical One Cloud Service

Starting in Clinical One Cloud Service 26.2, a new email address field is available in CTMS when creating site accounts. This email address can be integrated into Clinical One Cloud Service, reducing manual data entry and helping prevent duplicate site records by maintaining CTMS as the source of truth.

For more information about this integration, see Oracle Siebel CTMS Site Integration.

Key details:
  • If an email address is entered in CTMS, it is sent to Clinical One Cloud Service and populates the Organization (site) Primary Address email field under Global Settings–Organizations when the Organization (Institution) is created by the integration.
  • If no email address is entered in CTMS, the site integrates successfully, but no email address is populated in Clinical One Cloud Service.
  • Email addresses added or updated manually in Clinical One Cloud Service do not sync back to CTMS.

    Note:

    Enter email addresses only in the CTMS site account and not directly in Clinical One Cloud Service. Updates made directly in Clinical One Cloud Service may be overwritten or may result in duplicate Organization (site) Primary Address records in future integrations.
Integration template updates:
  • To support this enhancement, you must first upgrade to CTMS 26.3.
  • You must adopt a new integration template with additional mappings. Contact your Oracle point of contact to implement the template. Updates to existing templates are not supported.

Parent topic: Integrations