eTMF Overview

eTMF is a cloud-based electronic trial master file system that enables organizations to efficiently manage their clinical trials. With full support for the latest versions of the TMF Reference Model, eTMF Vault gives sponsors and CROs real-time access to clinical documentation at every point in a trial’s set-up, execution, and archival.

eTMF Features

Vault Clinical Basics eTMF provides a pre-configured environment for managing an electronic trial master file. This Vault consists of two main areas:

  • Clinical Admin
  • TMF Workspace

You will use the Tab Collections menu to toggle between these areas as necessary to complete your tasks. In addition to the tabs, there is also a Create button. The functionality of Create varies depending on the tab you have selected.

Clinical Admin

When you launch the Vault Basics Clinical application, the system automatically displays the Clinical Admin Window.This window includes these tabs:

  • Studies: allows creation and management of studies
  • Quality Issues: allows management of quality issues for TMF documents
  • Global Directory: allows management of organizations and personnel
  • Products: allows management of available products in Vault
  • Reports: provides a set of pre-defined reports and dashboards that end-users can view.
  • Users: allows management of access to available studies in Vault
  • Loader: allows you to load data to your Vault or extract data from your Vault in bulk.
  • Help: allows access to Vault Basics Help

TMF Workspace

To access the TMF workspace, select it from the Tab collections drop-down.This window includes these tabs:

  • Home: allows users to view all tasks and workflows associated with their user profile
  • Library: allows users to create a customized view of all items in their Vault Clinical Library
  • TMF Viewer: allows staff and inspectors to navigate the TMF in TMF RM v3.0 format
  • Reports: allows users to view a set of pre: defined reports and dashboards t
  • TMF Archive: allows users to view a list of all documents that have been archived
  • Help: allows access to Vault Basics Help