Required Roles: Workspace Manager (to configure), authorized Editors/Reviewers (to access)
Required Permissions: Folder-level permission to view unblinded data
Index
Overview
In regulated clinical and research environments, access to unblinded data must be carefully controlled to protect study integrity, maintain compliance, and prevent unintended disclosure or bias.
Kivo provides dedicated permission controls that allow Workspace Managers to explicitly grant or restrict access to unblinded content at the folder level. This ensures that only authorized users can upload or view unblinded documents—such as treatment allocation materials, unblinded analyses, interim reports, or restricted safety data—while all other users remain appropriately blinded.
Because exposure to unblinded information carries compliance and operational risk, Kivo treats unblinded access as a separate, explicit permission in addition to standard Read or Edit access. This article explains how unblinded data is handled in Kivo, how access is configured, and best practices for managing sensitive content.
How Kivo Controls Access to Unblinded Data
Access to unblinded data in Kivo is controlled through a dedicated permission toggle at the folder level. This permission works in addition to standard Read or Edit access.
Key characteristics of unblinded data control in Kivo include:
Unblinded access must be explicitly enabled for a user.
Users without this permission will not be able to view or upload unblinded documents.
Permissions are evaluated in the context of the folder where the document resides.
Inherited permissions apply, consistent with Kivo’s cascading permission model.
This approach allows teams to maintain a single folder structure while still enforcing strict access controls for sensitive content.
Granting Permission to View Unblinded Data
Only Workspace Managers can grant permission to view unblinded data.
To enable unblinded access for a user:
Enter Manager Mode.
Navigate to the cabinet or folder that contains unblinded content.
Select the folder and open Edit from the three-dot menu.
Scroll to the Permissions section.
Add the user (or locate the existing user entry).
Toggle View Unblinded Data to ON.
Once enabled, the permission applies to that folder and any child folders, unless overridden at a higher level.
What Authorized Users Can Do
Users who have permission to view unblinded data can:
Upload unblinded documents to the appropriate folders
View unblinded documents stored in those folders
Users without this permission:
Will not be able to view unblinded content
Cannot upload unblinded documents
Remain fully blinded, even if they have standard Read or Edit access
This separation ensures that study teams, auditors, and external collaborators only see information appropriate to their role.
Best Practices for Managing Unblinded Content
Limit access strictly. Only grant unblinded permissions to users who absolutely require it.
Use dedicated folders. Store unblinded documents in clearly designated folders to reduce the risk of accidental exposure.
Rely on group permissions where possible. For data monitoring committees or independent reviewers, use groups to manage access consistently.
Review permissions regularly. Periodically audit folder permissions to ensure access remains appropriate as teams change.
Document your process. Maintain internal SOPs that describe how unblinded data is handled in Kivo for inspection readiness.
Proper use of unblinded data permissions helps maintain compliance, protect study integrity, and ensure confidence in your clinical and regulatory processes.
Document Management > Access & Administration > Handling Unblinded Data in Kivo