Blind subject randomization numbers

Sponsor users can now hide randomization numbers in their studies to prevent unblinding.

In some cases, your study may call for blinding randomization numbers. For example, randomization numbers in large global studies can be potentially unblinding when blinded sponsor users have access to multiple countries' site data. By suppressing randomization numbers in your study, you prevent possible unblinding situations.

Details for sponsor users

As a sponsor user, here's what you should be aware of in your workflow:

Users assigned the existing Manage Subject Number Configurations permission can prevent randomization numbers from appearing in the system's user interface (UI) for their studies.
On the Study Settings tab, the new Blind Randomization Number setting allows you to hide subject randomization numbers throughout the system's UI for your study when set to Yes. Instead, Blind Randomization Number is displayed throughout the UI in places where a subject randomization number would typically appear.

Note:
Setting the Blind Randomization Number option to Yes, disables the Replace Subject Number with Randomization Number option.
Conversely, both the Replace Subject Number with Randomization Number and Blind Randomization Number settings can be set to No, and both are set to No by default.
- When the Blind Randomization Number setting is configured to Yes, the Subject Randomization notification displays the randomization number as Blinded.
- When a subject completes the randomization or dispensation visit, in the Randomization and Dispensation dialog, the randomization number shows as Blinded.
- Randomization numbers appear as Blinded in non-subject data forms for blinded users.
- When the Blind Randomization Number setting is set to Yes, randomization numbers are displayed as Blinded for blinded users in the Subject History side panel.
- The Blind Randomization Number setting configuration is taken into account at the time a report is run. If a user changes this setting from Yes to No after generating the report, the report is not impacted and the randomization number is shown in the report.

Impact on reports, extracts, archives, and datasets

The following reporting changes are introduced for this new feature when the Blind Randomization Number setting is configured to Yes:

Note:

You can configure your study to use blinded randomization numbers, but they won’t yet be available in the expected Blinded Kits and Blinded Subject Event datasets. They will be appropriately displayed in the blinded datasets once the new Analytics architecture is implemented for your organization's studies. More details on this feature and its release will be available soon. For more information on the Analytics re-architecture, see Improved performance in Oracle Clinical One Analytics with new data elements to track data reliability.

Report, extract, archive, dataset	Type of change	Description
Kit Dispensation report	Modified column data	The Subject's Randomization Number column displays as Blinded.
Randomization List (Blinded) report	Modified column data	The Randomization Number column displays as Blinded.
Subject Events report	Modified column data	The Randomization Number column displays as Blinded.
Oracle CRF Submit archives	Modified PDF output data	Randomization number instances display as Blinded.
Blinded Kits dataset	Modified data element description	When a randomization number is blinded, the RAND_NUMBER data element displays 0.
Blinded Subject Event dataset	Modified data element description	When a randomization number is blinded, the RAND_NUMBER data element displays 0.

Parent topic: Randomization and trial supply management