User management

Several new permissions give you more control and flexibility over managing workflow tasks, and the permissions required to update a study name have changed.

User permissions

New permissions for Confidentiality statement, CDA and Survey tasks

We added three new user permissions that separate the Confidentiality Statement, CDA and Survey tasks from the general Not Required permission.

If your Oracle Site Select role includes permission to manage other users or teams, you'll now see the new permissions under the Site management permission group, and you can add them to roles and teams as preferred:

• Complete task as Not required: Sign and return CDA: Allows you to mark a site's CDA task as Completed – Not required in the Site details Workflow drawer. The existing permission Complete tasks as not required will no longer allow you to mark a Sign and return CDA workflow task as Not required.
• Complete task as Not required: Feasibility survey: Allows the user to mark a site's Feasibility survey task as Completed – Not required. The existing permission Complete tasks as not required will no longer allow you to mark a Feasibility workflow task as Not required.
• Complete task as Not Required: Confidentiality Statement: Allows the user to mark a site's Confidentiality statement task as Completed – Not required. The existing permission Complete tasks as not required will no longer allow you to mark a Confidentiality statement workflow task as Not required.

Note:

Please use care when completing tasks as Not Required. Currently, once a task is marked as Not Required, the action cannot be undone.

New permissions for Generic Document submissions

This release introduces additional flexibility around how generic document review permissions are assigned and managed. We’ve separated the review permissions for generic document tasks from the broader CDA task settings.

You’ll find two new permissions in the CDA/Document Management permission group. If your Oracle Site Select role allows you to manage roles or teams, you can assign these as needed:

1. Review and Approve All Generic Document Submissions: Allows the user to view, review, and approve all generic document submissions.
2. Review and Approve Generic Document Submissions for assigned sites Only: Allows the user to view, review, and approve only the generic documents for sites assigned to them.

As part of your account’s upgrade to Release 25.1, users with existing CDA permissions will automatically receive one of the new generic document permissions as follows:

• Users with Negotiation for assigned CDA/Document submissions only or Review and Approve All CDA/Document Submissions will now have Review and Approve All Generic Document Submissions permission
• Users with Review and Approve Assigned CDA/Document Submissions Only will now have Review and Approve Generic Document Submissions for Assigned Sites Only permission

Please note that CDA and generic document permissions are not linked by default. When assigning roles or creating teams, selecting a CDA permission will not automatically assign a corresponding generic document permission. Be sure to manually add the appropriate generic document permission when needed.

EPIC: SEL-17867

Study names

In this release, we modified the permissions required to edit a study name. Previously, you needed Study details management and Study administration permissions. With this enhancement, you’ll need Study details management and Account study creation permissions to edit the study name.

EPIC: SEL-17867