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.

Reach out to your Oracle point of contact if more information is needed.

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

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

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.

• Screen a subject

  You choose the data to send.

• Screen fail a subject, and undo screen failure
  • 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. The status for the subject in the third-party EDC system isn't changed.
  • For undo screen failure, the screen failure date is updated to blank in the third-party EDC system. The status for the subject in the third-party EDC system isn't changed.
• Randomize a subject

  You choose the data to send.

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

• Complete a subject's visit

  You choose the data to send.

• Withdraw a subject, and undo withdrawal
  • For subject 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 undo subject withdrawal, 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.
  • Data for these events can be sent for subjects who failed screening, as well.
• 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 item in the third-party EDC system.