Essential Document Tracking

The Essential Document Tracking link provides access to the EDT feature for that clinical trial.

EDT is created with a product container and (3) requirements containers:

• Product File Container – contains the product documentation that is related to the products listed in the Investigational Products file.
• Trial Documents Container – contains each requirement that must eventually have a corresponding document in the Trial File on the clinical trial SharePoint workspace.
• Country Documents Container – contains each requirement that must eventually have a corresponding document in the Country File on the clinical trial SharePoint workspace.
• Site Documents Container – contains each requirement that must eventually have a corresponding document in the Site File on the clinical trial SharePoint workspace.

The requirements that are listed in each container are added based upon the requirements listed in the EDT template that was used to create the clinical trial. Each requirement is added with a status of “Missing” indicating that the corresponding document has not yet been added to the SharePoint Trial Master File.