Choose when subject numbers are assigned

With the new Assign Subject Number study-level setting, study managers can choose when subject numbers are assigned, either when the subject is added or after screening.

Sponsors can now configure how subject numbers are assigned, choosing between assignment at the time of subject addition or after the completion of the Screening visit. This enhances alignment with operational requirements and strengthens control over subject data.

Before you work with this feature

No new permission or role is introduced along with this feature. However, as a user manager in your study, you must ensure that the sponsor user configuring this setting is assigned the View Study Settings and Edit Study Settings permissions.

Details for study managers or other sponsor users

If you're a study manager or any other sponsor user who's in charge of configuring your study's settings, here's what's new for you:

  • On the Study Settings tab, there's a new setting available called Assign Subject Number.

    Note:

    This setting is set to When subject is added by default.

    You can only set it to When subject is screened if your study has a Screening visit as the first visit in the study's schedule.

  • The Assign Subject Number setting is only displayed if the setting Allow Subjects to be Manually Added is set to Yes.
  • If the Assign Subject Number setting is set to When subject is screened, the Allow Screen Fail before Screening option - for the Screen Failed Subjects setting - is unavailable.
  • The Apply to All Modes button is unavailable for use due to the setting's mode-specific nature. This means that you must configure the setting in each mode (Testing, Training, or Production) separately.

  • The Assign Subject Number setting can be updated for a specific study mode when the study version and design at the site support it. However, if prerequisites aren't met, the setting cannot be changed.

    For example, if the study version associated with sites in Testing mode lacks a screening visit as the first scheduled and required visit in the schedule, you cannot switch from When subject is added to When subject is screened.

You can find additional information about this new setting in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Details for study designers

There's nothing new in your workflow. However, remember to always work with your study manager to ensure that you align the study's design with the way the Assign Subject Number setting is configured. If this setting must be set to When subject is screened, you need to include a required screening visit as the first visit in the schedule and follow specific requirements when designing forms.

You can find additional information about your design requirements for screening visits in the Study Designer User Guide after the RAE upgrade.

Details for site users

If subject number assignment during subject addition is enabled in your study, your workflow remains the same. The application assigns a subject number when you select Add Subject to add a new subject.

If subject number assignment is only allowed when screening has occurred, you'll first have to screen a subject before adding them to the study. Furthermore, you'll encounter the following User Interface (UI) and workflow changes:
  • The Add Subject button label is updated to Screen Candidate.
  • Upon completing the Screening visit forms, you can select Cancel or Submit. Selecting Submit completes the screening process, assigns a new subject number, and adds the subject in the study with a Screened or Screen Failed status, as indicated by a new dialog that informs you of the screening state.
  • If your study includes additional visits after the Screening visit, the new dialog displays a Next Visit button. You can click it to move to the next visit (if applicable). The Return to All Subjects button lets you return to the Subjects page.
  • The Manage Subjects button isn't enabled until you complete the Screening visit and the subject is assigned a number in the application.

You can find additional information about this new feature in the Site User Guide after the RAE upgrade.

Impact on reports, archives, and Analytics datasets

Note:

CRF Submit archives and Oracle Clinical One Analytics datasets include only subjects with assigned subject numbers, as expected, whether assigned at addition or after completing the Screening visit.

The following reporting changes are introduced for this new setting:

Report Type of change Description
Study Design report New data point The Study Settings section displays the name of the configured Assign Subject Number setting. It also displays the last update time, and the user who made the update.
Study Settings report New column The Study Settings tab now includes a new column: Assign Subject Number. The tab also displays the last update time, and the user who made the update.

You can find additional information about this new setting in the Reporting Guide after the RAE upgrade.

Impact on integrations

If your study includes integrations with Oracle Clinical One Analytics, Oracle Clinical One Digital Gateway, or Oracle DMW, no subject-specific data is sent to any of these downstream applications until a subject number is assigned.

If your study integrates with Oracle Central Coding and the Code data for new and screen failed subjects setting on the Study Settings tab is disabled, Oracle Central Coding data will not be sent until the subject is enrolled or randomized.

Already working in a live study?

You can update the new Assign Subject Number setting if the study version and design meet the prerequisites for the selected study mode (Testing, Training, Production). If the prerequisites aren't met, the setting cannot be changed.

You can find additional information about these prerequisites in the Sponsor and CRO User Guide after the RAE upgrade.

Parent topic: Data collection