Before File Reviews can be created, one or more File Review Templates must be configured by a Business Administrator or other user with TMF Manage File Review Templates permissions. A File Review Template defines the characteristics for a particular type of File Review, including the following:

• The minimum percentage of Study Items to include as Review Items
• The types of Study Items to include as Review Items (e.g., empty Study Items)
• Mandatory Document Types
• Excluded Document Types
• Limits on Finalized Documents and Empty Study Items
• The groups of users who can create and manage, conduct, and view File Reviews

Once templates are defined, authorized users can create new File Reviews based on the templates.

Note: A File Review Template must be made effective for it to be available for use during File Review creation.

The File Review Templates List Page in eTMF displays a list of File Review Templates defined and options for managing those templates. From the File Review Templates List Page, you can also create new File Review Templates.

To access the File Review Templates List Page, select “View Configurations” from the More Actions Menu in the Global Header and select “File Review Templates” from the Breadcrumb Menu.