Introduction

This document provides orientation on eTMF components and the EDT feature and how they interact within the Clinical eTMF solution.

To comply with regulatory requirements of clinical trials, organisations must maintain and store the required documents and images in a Trial Master File (TMF). This file is now maintained in an electronic form known as the elecronic Trial Master File (eTMF). The Clinical eTMF module allows users to easily manage clinical trials using SharePoint workspaces and workflows that help them create, review, and approve dcouments related to the eTMF.

The application uses role-based access control to provide access to all members based on their respective role and trial responsibilities, thus improving communication among the clinical team members.

Clinical eTMF features Essential Document Tracking (EDT), which allows users to manage and control the quality of regulated clinical trial content to demonstrate its compliance with good clinical practice methodologies to investigators, sponsors, and monitors.

The features described in this document make up the baseline solution. Keep in mind that the deployment environment may vary depending on the local configuration and requirements.