Updates to user permissions

As part of Clinical One Cloud Service 26.3 and 26.3.0.1, we have introduced changes to permissions related to study settings, supply settings, regions, sites, and queries management.

Updates to study settings permissions

New permissions have been added to provide more granular control over which users can edit different study settings. Clinical One Cloud Service now has separate authorization controls to update the Rescreen Subject Settings and for the Enrollment and Custom Enrollment Settings. As a result, custom roles can now be configured to limit users with edit access to only one of these sections.

The following new permissions are added as part of Clinical One Cloud Service 26.3.0.1:

Permission	Description
Edit Rescreen Subject Settings	This permission allows users to only edit the rescreen subject settings.
Edit Enrollment and Custom Enrollment Settings	This permission allows users to edit both the Enrollment Settings and the Custom Enrollment Settings sections.

The existing permission Edit Study Settings remains unchanged, allowing users to update all sections within the Study Settings tab without restriction. Study user administrators may need to update custom roles, but only need to replace this permission with any of the new ones if they want to restrict a user's access to specific management activities.

The existing permission View Study Settings allows users to view all sections in the study settings tab, including those that users may not have access to edit.

Updates to supply settings permissions

New permissions have been added to provide more granular control over which users can edit different supply settings. Clinical One Cloud Service now has separate authorization controls to update the Schedule Settings section, the resupply strategies and blinded groups; and for the Locally Sourced Kits Settings. As a result, custom roles can now be configured to limit users with edit access to only one of these sections.

The following new permissions are added as part of Clinical One Cloud Service 26.3.0.1:

Permission	Description
Manage Schedule Settings and Resupply	This permission allows users to only edit the Schedule Settings section on the main page of the Supply Settings tab, and the sections on the sidebar, which include: Min/Max Resupply Predictive Resupply Blinded Groups (when used in the study)
Manage Locally Sourced Kit Settings	This permission allows users to edit the Locally Sourced Kits Settings section only.

The existing permission Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies remains unchanged, allowing users to update all sections within the Supply Settings tab without restriction. Study user administrators may need to update custom roles, but only need to replace this permission with any of the new ones if they want to restrict a user's access to specific management activities.

The existing permission View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies allows users to view all sections in the Supply Settings tab, including those that users may not have access to edit.

Updates to region management permissions

Randomization Regions settings are managed from the Study Settings tab. Many sponsor level roles have the rights to manage the study settings, but, when the randomization is stratified by region, updating regions would impact randomization. Starting from Clinical One Cloud Service 26.3, to prevent unintended impacts on randomization, the ability to create or edit regions is now only controlled by the Edit Regions permission. Users assigned with the Edit Study Settings permission no longer have the ability to create regions, unless they are also assigned with the Edit Regions permission.

The Edit Regions permission is limited to the Statistician template study role, and is now removed from Study Manager and Rules Designer template study roles.

Updates to site management permissions

When managing sites, you define the following from the Create or Edit site dialogs:

• Site information (Info tab)
• Site addresses (Addresses tab)
• Kits shipping addresses (Kits tab)

Not all users with the ability to create sites should have access to the kits information. For example, Clinical Supplies Managers may only need to update the site addresses and the kits details. Similarly, Site Administrators typically should not be able to modify where the kits are being shipped.

Two new permissions are added as part of Clinical One Cloud Service 26.3 to further control the exact site management tabs that a user can access:

Permission	Description
Manage Site Shipping Address and associated Kits	This permission allows users to only update the site addresses and the kits details. With this permission users can only edit sites, not create them.
Add and Manage Site No Kits	This permission allows to create and edit sites, but only allows users to define the site information and its addresses (no access to the kits details).

The existing Create and Manage Sites permission remains unchanged, allowing users to create sites and to update all site details. Study user administrators may need to update custom roles, but only need to replace this permission with any of the new ones if they want to restrict a user's access to specific site management activities.

Updates to query management permissions

As part of Clinical One Cloud Service 26.3, there is an update on the different permissions that allow to re-assign queries:

• The Answer Assigned Queries permission no longer allows to re-assign queries.
• The Create Queries now allows to re-assign queries.

You can find more information about all these permissions in the Add Users Guide after the assessment environment upgrade.