Blinded and Unblinded Support in Siebel Clinical

Siebel Clinical provides the option to have and the ability to manage both blinded and unblinded users for clinical trials in Siebel CRM 20.7 Update and later releases.

Key issues to note about blinded and unblinded support in Siebel Clinical include the following:

1. All users are blinded by default in Siebel Clinical Trial Management System (CTMS).

   • Blinded users can view blinded data.

     Blinded users cannot view unblinded data in Site Visits and Activities.

   • Unblinded users can view unblinded data.

     Unblinded users can either view blinded data in Site Visits and Activities in read-only mode (this is the default behavior) based on a study level preference setting or they cannot view blinded data in Site Visits and Activities at all. The study level preference setting, Hide blinded content for unblinded users, is controlled by the Siebel Clinical administrator – see Controlling Access to Blinded Data for Unblinded Users for more information.

2. The Siebel Clinical administrator can associate either blinded or unblinded users to the study team at the protocol, region, or site level.

3. A user can be blinded at some sites and unblinded at others in the same study, and this is controlled by the Siebel Clinical administrator.

4. Site Visits, Activities, and Document Tracking created by blinded users are blinded.

5. Site Visits, Activities, and Document Tracking created by unblinded users are unblinded.