Product File Document Library

Upon activation of Clinical eTMF, the system creates a product level SharePoint document library at the hub site to manage product-level documents. This library contains a folder for each product listed in the Investigational Products list. The Product File Container on a workspace contains links to a filtered view of the hub Product File library folders containing the product documentation related to the product(s) associated with the clinical trial.

Documents are added to the Product File using the Smart Document feature. These documents can be processed through a lifecycle to be approved.