Outbound subject data integration

You can send subject event data from Oracle Clinical One Platform to a third-party Electronic Data Capture (EDC) system, based on the configuration settings you specify in the Oracle Clinical One Platform.

Configuration Service details for this integration

B92665: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.

Note:

For more information see, Oracle Life Sciences Cloud Consulting Professional Services, Service Descriptions and Metrics.

If you require more information, reach out to your Oracle point of contact.

Which data can Oracle Clinical One Platform share with a third-party EDC system?

Note:

For this type of integration, you must not apply data flags to any form fields in a Oracle Clinical One Platform study. Including data flags in an integrated study will cause integration failures.

All event data is sent to a third-party EDC system at the intervals defined in the integration schedule.

Type of data Details
Screen a subject

You choose the data to send from Oracle Clinical One Platform to the third-party EDC system.

Oracle Clinical One Platform sends screening data to the third-party EDC system based on one of two screening events.
  • Integrate data at visit complete: The screening visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Screen button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the screening visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Screening, the Screen button is enabled, and when selected, the data is integrated.

    For more information about this option, see Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the screen event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.
    • The study design must include the Informed Consent Date as a required question in order to integrate it with the screening event.
    • Integration template updates are required. Reach out to your Oracle point of contact for assistance.
Screen fail a subject, undo a subject's screen failure, or update a user's screen failure date and reason
  • For screen failure, the screen failure date and reason along with any other relevant information related to the screen failure event are sent to the third-party EDC system. You can map these fields to any form you use to collect the screen failure reason. In the third-party EDC system, the subject's status isn't changed.
  • For undo screen failure, the screen failure date is updated to blank in the third-party EDC system. In the third-party EDC system, the subject's status isn't changed.
Randomize a subject

You choose the data to send from Oracle Clinical One Platform to the third-party EDC system.

Note: Data for these events can be sent for subjects who failed screening, as well.

Oracle Clinical One Platform sends randomization data to the third-party EDC system based on one of two randomization events.
  • Integrate data at visit complete: The randomization visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Randomize button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the randomization visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Randomization, the Randomize button is enabled, and when selected, the data is integrated.

    For more information about this option, see Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the randomize event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.
    • Integration template updates are required. Reach out to your Oracle point of contact for assistance.
Complete a study for a subject, undo a subject's study completion, or update a subject's study completion date
  • For a subject's study completion event, the completion user-entered date and reason, as well as any other relevant information for a subject's completion event, is sent to the third-party EDC system.
  • For the undo study complete event, the completion date and other details that were sent to the third-party EDC system are cleared. In the third-party EDC system, the subject's status isn't changed.
  • In the Oracle Clinical One Platform, if a user manually clears question fields in the resurfaced study completion visit, no job failures occur for this action. Jobs associated with the clear event should succeed in Oracle Clinical One Digital Gateway.
  • In the Oracle Clinical One Platform, if a user manually updates question fields in the resurfaced study completion visit, this updated value will integrate into third-party EDC system without any jobs failing.
Withdraw a subject, undo a subject's withdrawal, or update a subject's withdrawal date and reason
  • Data for these events can be sent for subjects who failed screening, as well.
  • For a subject's withdrawal, the withdrawal form in the third-party EDC system is updated with the withdrawal date and reason, as well as any other relevant information.
  • For the undo subject withdrawal event, the completion date and other details that were sent are cleared out in the third-party EDC system. Oracle Clinical One Platform retains the information in the withdrawal form.
  • In the Oracle Clinical One Platform, if a user manually clears question fields in the resurfaced withdrawal visit, no job failures occur for this action. Jobs associated with the clear event should succeed inOracle Clinical One Digital Gateway.
  • In the Oracle Clinical One Platform, if a user manually updates question fields in the resurfaced withdrawal visit, this updated value will integrate into third-party EDC system without any jobs failing.
Code break

If a user performed a code break in Oracle Clinical One Platform, Oracle Clinical One Platform sends the date and time when the code break was performed to the third-party EDC system.

Kit replacement

Note: If your study uses non-serialized kits and you would like data about non-serialized inventory sent to the third-party EDC system, reach out to your Oracle point of contact.

When a kit is replaced, the dispensed kit information is updated with the replacement kit information on the specified form and question in the third-party EDC system.

Parent topic: EDC Systems