Support for undoing subject events

The undoing of a subject's Withdrawal and Study Completion visits is now supported for specific Oracle Clinical One Digital Gateway integrations with Oracle Clinical One Platform studies.

Details for integration managers

Moreover, user-edited dates and details for a subject's Withdrawal and Study Completion can be integrated. The integration logic for sending data related to Screen Failure, Study Completion, or Withdrawal events is not changing as part of this feature.

For more information about this new enhancement, see Manage subject event related data and visits better.

The following integrations now support the transmission of data related to a subject's Withdrawal, Screen Failure, and Study Completion visits. This includes data related to undone events or edited dates for the Withdrawal and Study Completion events:
  • The integration between Oracle Clinical One Platform and Oracle InForm
  • The integration with Medidata Rave
  • The integration between Oracle Clinical One Platform and Oracle's Siebel Clinical Trial Management System (CTMS).

Reach out to your Oracle point of contact if you would like to update the integration's configuration to support the integration of data related to a subject's Withdrawal, Screen Failure, and Study Completion events. If you don't update the integration configuration file, the data doesn't integrate.

You can find additional information in the Digital Gateway User Guide after the Release Assessment Environment (RAE) upgrade.