Understand impact of subject number assignments on study data

Learn how the timing of subject number assignment - whether during subject addition or after submitting screening forms - affects study data, data propagation in downstream applications, and overall system behavior.

Note:

When a subject number is assigned after the screening forms are submitted, there is common downstream impact regardless of whether the screening is successful or fails:
  • Subject data is available for all applicable integrations, reports, CRF Submit archives, Oracle Clinical One Analytics datasets, and Oracle Central Coding.

    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.

  • Custom JavaScript rules and Source Data Verification (SDV) workflows are triggered.
  • Manual queries can be raised on subject data, while automated queries are triggered by custom JavaScript rules and validation rules.
  • EHR linking occurs later by selecting the appropriate option on the Manage drop-down.

When a subject number is assigned depends on the study configuration and user actions. The following table shows the differences across use cases and their impact on study data.

Subject number assignment type and use case Study data impact
Subject numbers are assigned upon addition - site user adds and screens a subject (whether successfully or not)
  • The system checks enrollment or screening limits. If limits are reached, the system prevents the screening, as well as the subject number assignment, and shows an error. Any data that was collected and saved during the screening visit would remain.
  • If within limits, the system assigns a subject number (whether manually or automatically) when adding a subject .
  • As soon as the subject is added to the study, data on the subject is available in the applicable integrations, reports, CRF Submit archives, and Oracle Clinical One Analytics datasets.
  • The subject's status changes to Screened or Screen Failed only after the screening visit is complete.
Subject numbers are assigned upon addition - site user cancels or leaves the screening forms
  • The subject is already assigned a number, so they remain visible on the Subjects page with a status of New.
  • Any data collected until then is automatically saved and preserved in the system.
  • The subject's status remains New until screening is completed (whether successfully or not).
Subject numbers are assigned upon screening - site user screens a candidate (whether successfully or not)
  • The system checks enrollment or screening limits. If limits are reached, the system prevents the screening, as well as the subject number assignment, and shows an error. No data is saved or propagated.
  • If within limits, and the study assigns numbers automatically, the candidate is screened and a subject number is assigned successfully. If the study requires site users to manually assign subject numbers, the site user is prompted to enter a valid subject number and submits the screening data. If the site user cancels the manual subject number assignment, the previously collected data is still displayed in the screening forms, but that data isn't saved or submitted in the system.
  • The subject's status changes to Screened or Screen Failed only after the screening forms are submitted.
  • Site users cannot manually screen fail a subject until the subject has been screened.
Subject numbers are assigned upon screening - site user collects data but cancels or leaves forms without submitting data
  • The system shows a warning to prevent accidental data loss.
  • The system doesn't assign a subject number if the site user cancels, doesn't submit, or leaves the screening form.
  • No new subject appears on the Subjects page.
  • No subject data is displayed in reports, CRF Submit archives, Oracle Clinical One Analytics datasets, Oracle Central Coding, or other integrations.
  • Manual queries, automated queries, notifications, and other custom JavaScript rules cannot be raised for that specific subject until a subject number is assigned.

Parent topic: Specify study, enrollment, and visits settings