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.

Vault eTMF is part of the Vault Clinical Operations family of applications. Within a single Vault, your organization can have one, two, or all of these applications. These applications share a common data model, but each provides additional pieces of functionality to help manage the clinical trial process.

eTMF Features

Vault eTMF is built on the Vault platform and therefore has all features that we describe in the platform help topics. In addition, eTMF provides these capabilities specific to planning and managing documents for a clinical trial:

  • TMF Bot: Automates document classification and the setting of key metadata within the Document Inbox and in document workflows.
  • TMF Homepage: View critical metrics related to your trial master file on the TMF Homepage.
  • Object Configuration: Manage and customize the study hierarchy, milestones, and the Person and Organization objects. eTMF also includes Model and Artifact objects to represent the latest TMF Reference Models.
  • Document Types: View documents in the TMF Reference Model structure with the TMF viewer. We’ve based the default document type structure included in Vault eTMF on the TMF Reference Model.
  • Document TMF Auto-Filing: Automatically file documents into the correct TMF binders at the study-, study country-, and site-level.
  • Milestone Templates: Add milestones in bulk to studies, study countries, and study sites that are consistent across studies and follow country-specific business practices.
  • Study Product Defaulting: Automatically default the correct products into the Product field on any documents that have a value in the Study field.
  • Study Selector: Filter documents with the study selector to focus on the documents needed at a particular time.
  • Read & Understood Workflows: Facilitate the distribution of approved documents to study team members and track who has acknowledged receipt of those documents with Read & Understood workflows.
  • CRF Import: Many organizations use Medidata Rave EDC or other systems to collect clinical data and assemble subject case report forms. Use eTMF’s CRF Import feature to quickly and easily file all final subject CRFs for a study in a Vault.
  • Medidata CTMS Integration: Use Medidata CTMS as the source for Study, Study Country, Study Site, and Location data in an eTMF Vault and automatically sync visit reports using Medidata.
  • Study Person: Easily administer Vault security by assigning users to roles for a specific study and scope (study countries and study sites).
  • TMF Viewer: Browse dynamically organized content and switch between multiple configured hierarchies with the TMF Viewer.
  • Managing Unblinded Content: Define which users can create unblinded (restricted) content related to a study and which can create blinded (unrestricted) content.
  • Quality Issues: Track, manage, and report on quality issues in your Vault using the Log Quality Issue user action and the Quality Issue object.
  • TMF Index Management: eTMF Vaults include standard objects, fields, and lifecycles to help you define, manage, and version your TMF Index.
  • Study Archival: Archive studies, including study documents, document audit trails, and study-related records after a clinical trial is complete.
  • Document Field Data Migration: You can request that Veeva Support migrate custom Date and Picklist document field data in your Vault to existing standard (__v) Date and Picklist document fields.

Standard Connections

RIM to Clinical Operations Vault Connection

This Vault to Vault Connection between a RIM Submissions Vault and a Clinical Operations eTMF automates data sharing between the two applications, supporting the automatic transfer of Product, Study, and Site data and documents. See details about the RIM to Clinical Operations Vault Connection.

Learn about using the Vault eTMF application in these articles:

Admin Articles

Learn about configuring the Vault eTMF application in these articles: