1. Change Log
  2. Oracle Clinical One Platform and Oracle Clinical One Digital Gateway 23.3 (December 2023)
  3. What's new
  4. Data collection
  5. Replace the subject number with the randomization number after randomization

Replace the subject number with the randomization number after randomization

A new study setting allows the subject number to be replaced by the randomization number after randomization.

Before you work with this feature

  • To view and configure this new setting for replacing the subject number, a sponsor user must be assigned the new permission called Manage Subject Number Configuration.

    Tip:

    To access the Study Settings tab, a user must be assigned the existing View Study Settings and Edit Study Settings permissions.

Details for sponsor users

  • With the appropriate permission, you can find the new setting on the Study Settings tab. The setting is called Replace Subject Number with Randomization Number.
  • This new feature is available in all modes: Testing, Training, and Production and it is mode-specific. This means you can enable the setting in Production mode, where no subjects have been screened or enrolled, even if subjects were already screened or enrolled in Testing or Training mode.
  • Subjects are still initially assigned a subject number after being screened or enrolled. After randomization, the subject number is replaced by the randomization number, and the original subject number is referred to as the screening number in the User Interface (UI) and reports.
  • The new subject number is propagated throughout the system in the following application areas:
    • The User Interface (UI)
    • All dialog windows
    • Post-randomization notifications
    • All reports that include the subject number
    • The Subject Data Extract
    • Oracle CRF Submit archives and reports
    • Select Oracle Clinical One Digital Gateway configured integrations

Impact on reports and notifications

  • The Subject Data report includes a new column called Screening Number.
  • The Subject Number column in the Subject Events report has been renamed to Screening Number.
  • The Subject Data Extract includes a new column, called SCRNID, to collect the Screening Number.

    WARNING:

    As stated above, a new column, SCRNID, has been added to the Subject Data Extract, resulting in a new header. If you have programming based on the column positions in the extract, modifications to your programming may be required.

Already working in a live study?

  • This feature is available for existing studies started before 23.3, when no subjects have been screened or enrolled.
  • The setting is grayed out if subjects were screened or enrolled in a specific mode.

More information about this feature can be found in the Sponsor and CRO User Guide, under Study Settings, after the Release Assessment Environment (RAE) upgrade.