Which data can be shared with a third-party electronic data capture system?

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

• 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.

• 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.
• Code break

  If a user performs 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

  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.