How settings are impacted when replacing a subject number with randomization number

When you replace a subject's number with a randomization number, multiple settings in your study might be impacted.

When the setting is enabled, subjects are still assigned a subject number after being screened or enrolled. The randomization number then replaces the subject number after randomization, and the original subject number is now referred to as the Screening Number.

The new subject number is updated throughout the study. The table below provides information about how the setting impacts your study.

Table 4-2 Details about the impact to your studies

Impacted area	Details
User interface	The new subject number is displayed in the user interface anywhere the original subject number was displayed, including all dialog windows. When sorting subjects on the all-subjects screen, the system uses the Screening Number (the original subject number assigned after screening or enrollment). This ensures sorting reflects the order in which subjects were added to the study. When searching for subjects on the all-subjects screen, users can search using Screening Number (the original subject number assigned after screening or enrollment) or the new subject number (assigned after randomization).
Randomization lists	If the randomization number is updated in the Randomization List after the number was assigned to a subject, the updated value overwrites the randomization number (subject number) in the study. Note: While in Testing mode, Oracle Clinical One Platform restricts the use of duplicate subject numbers. To ensure accurate testing and avoid issues, do not import the same randomization list after randomization testing has started. This ensures the system does not attempt to use the same randomization number twice.
Re-randomization	The new subject number, assigned after initial randomization, is not updated if a subject is re-randomized.
Randomized in error	Replacing the subject number with the randomization number only occurs once per subject. The one exception is if a subject is randomized in error. The randomization number, assigned in error, remains associated with the subject until it is updated to Randomized in Error in the Randomization List. When that is done, the subject number is reverted to the subject number assigned after screening or enrollment. If the subject is randomized in the future, the randomization number replaces the subject number. Note: If a randomization number is manually assigned to a subject randomized in error, the subject number is not updated. For more information, see Manually assign a randomization number to a subject.
Update Subject Number(s) permission	Selecting Update Subject Number(s) from the Manage Subjects drop-down on the All Subjects screen results in an update to the Screening Number, not the new Subject Number.
The Subject Number Format setting	The Subject Number Format setting on the Study Settings tab does not apply to the randomization number assigned to a subject; it only applies to the initial number assigned to a subject after screening or enrollment, which is also reflected in the Screening Number.
Notifications	Notifications include the current subject number displayed in the user interface. Notifications sent as a part of or after randomization include the new subject number. For more information about notifications, see the Notifications and Permissions Guide.
Standard reports	For more information about standard reports, see the Reporting Guide. Once the subject number is changed, the new subject number is associated with all data, including data collected before the change. The following reports are uniquely impacted: Subject Data report The report output includes a column to capture the Screening Number, populated with the original subject number assigned after screening or enrollment. After randomization, the Subject Number column displays the randomization number, and the Screening Number column remains unchanged. Study Design report The setting that controls this functionality is not available in design mode, sometimes called draft mode, and, therefore, is not included in the report when generated in design mode. The setting appears in the report output for the three other modes (Testing, Training, and Production) if the permission that controls the setting is added to any study role. Subject Events Report Before randomization, the Current Subject Number and Screening Number columns display the subject number assigned after screening or enrollment. The Previous Subject Number column also displays N/A. After randomization, data is displayed in the following ways: Current Subject Number column displays the randomization number. The original subject number (assigned after screening or enrollment) is displayed in the Screening Number column. And the Previous Subject Number column displays N/A. Note: If the Screening Number is edited, the new number appears in the Screening Number column, and the previous Screening Number is displayed in the Previous Subject Number column. The report contains an entry to record the activity. The Event Type and Reason columns are populated with Randomization Number assigned to subject number.
Subject Data Extracts	The Subject Data Extract includes three columns containing data related to the subject number. USUBJID: Also referred to as the subject GUID. This is a unique value across all studies and does not change if the subject number does. SUBJID: This is a unique value within a study and contains the original subject number or the new subject number after randomization. SCRNID: This is the Screening Number, the original subject number assigned after screening or enrollment. The Screening Number is displayed even if the setting is not enabled. The value is updated if the Update Subject Number(s) option is used under Manage Subjects on the subject listings page. For more information, see Subject Data Extract.
Oracle Clinical One Analytics	Integrating the updated subject number is planned for a future release. Until then, the new subject number is not present in Oracle Clinical One Analytics. For more information about Analytics, see Get started with Oracle Clinical One Analytics
Oracle Life Sciences Data Management Workbench (DMW)	The integration between Oracle Clinical One Platform and DMW continues to work. This is because the subject GUID, which does not change if the subject number does, is the unique identifier used when exchanging data between the two systems. However, even though the integration continues to work, the updated subject number is not currently present in DMW. Integrating the updated subject number is planned for a future release.
Oracle CRF Submit archives and reports	Requests that use Now for the As of Date include the new subject number once a subject is randomized. Requests that use an As of Date before randomization reflect the initial Subject Number assigned after screening or enrollment, and a date used after randomization reflects the new subject number. The Subject ID column in the Download Log report may contain a single subject's original and new subject numbers. This is because the report is an audit history for downloads of PDFs and reports, which can occur before and after randomization. For more information about Oracle CRF Submit, see Oracle CRF Submit archives and reports
Oracle Clinical One Digital Gateway configured integrations	Note: Review this section in future releases to see additionally supported Oracle Clinical One Digital Gateway configured integrations. Oracle Clinical One Platform can send the updated subject number to an integrated third-party system. Make sure the other system is capable of processing such an update. If not, you may want to reconsider enabling this setting. Supported integrations Oracle Clinical One Platform to Oracle InForm In addition to the new setting being enabled, a configuration update is required to take advantage of this feature. Work with your Oracle Services Consultant to apply the necessary updates.
Oracle Central Coding	This feature is not supported in Oracle Central Coding. Verbatim terms, present in Oracle Central Coding, entered before and after randomization, remain associated with the original subject number assigned after screening or enrollment.
Subject migration	The APIs that migrate subjects populate the database with the original subject number (assigned after screening or enrollment) and the new subject number (assigned after randomization).