The Review Manager for a File Review can add new Non Document Review Items on an ad hoc basis (for example, if the Review Manager determines a necessary verification that was not included during File Review creation).

Prerequisites: To add a Non Document Review Item to a File Review, you must be a member of the TMF Create File Reviews feature group and you must be a member of a Review Manager Group for the template on which the File Review was based.

1. Navigate to the Study Item List of the study for the File Review.
2. From the Study Items Breadcrumb Menu, select “File Reviews.” The File Reviews List Page is displayed.
3. Select the hyperlink for the File Review you want to work with. The File Review Items List Page is displayed.
4. Select the gear icon above the list and select “Add Non Document Review Item” from the Actions Menu. The Create Non Document Review Item screen appears.
5. In the Name field, enter text for the Non Document Review Item.
6. Select “Create.”

A placeholder for the Non Document Review Item is added to the File Review Items List Page.