Study impact when replacing a subject number with the randomization number
See how your study is impacted when you replace a subject number with a randomization number.
When the setting Replace Subject Number with Randomization Number is enabled, subjects are still assigned a subject number after being screened or enrolled.
After randomizing a subject, the randomization number replaces the subject number throughout the study, and the original subject number is referred to as the Screening Number.
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 |
|
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.
|
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 |
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 Extracts |
The Subject Data Extract includes three columns
containing data related to the subject number.
For more information, see Subject Data Extract. |
Oracle Clinical One Analytics |
For the following datasets, the Subject folder
contains a SCREENING_NUMBER data element. This is a static
element that always displays a subject's original screening
number.
After you randomize a subject:
For more information about Analytics, see Get started with Oracle Clinical One Analytics |
Oracle Life Sciences Data Management Workbench (DMW) |
|
Oracle CRF Submit archives and reports |
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 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). |
Parent topic: Specify study, enrollment, and visits settings