Pre-Requisite

The Clinical Research Associate (CRA) user responsible for creating and managing Site Visit Documentation in a Site must have the Site & Visit Editor permission.

Unblinded users will have the right to create unblinded site visits and related documentation, which will only be visible to other unblinded personnel.

Important

• Any details created within a site visit type designated as Unblinded will be restricted from view by users who do not have an unblinded access permission for the Study or Site.
• Unblinded designation on site visits is typically limited to only site visits where users want to restrict the visibility of potentially confidential restricted data (e.g., activities)
• If there are no site visit report templates designated as Unblinded, and the visit is of an unblinded type, users will not be able to generate documents without configuration changes/updates. Those changes have to go through the change management process.
• Unblinded site visit document will only auto-file to an unblinded eTMF.
• The 'Open' Label is not the same as Unblinded in Trial Interactive’s CTMS designations.

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