Clinical eTMF-EDT Guide
Introduction
Using this guide
eTMF Architecture
Clinical eTMF Architecture
Package Deployment
Access Package Deployment
EDT Security
Definitions
EDT & eTMF Hubs
eTMF Hub
Clinical eTMF Reference Lists
Clinical Trial Workspace Template
Product File Document Library
Investigational Product List
Hub Security and Authorization
Smart Document Feature
EDT Hub
Dashboard
Index Management
Settings
Clinical Trial Creation
Add a New Clinical Trial
View or Edit a Clinical Trial
eTMF Trial Site
Clinical Trial Workspace Security and Notifications Groups
eTMF Trial Components
Trial Master File
Essential Document Tracking
Investigation Sites
Clinical Trial Site Locations
Clinical Trial Site Personnel
EDT Trial Site Feature
Essential Document Tracking Components
Dashboard
Explorer
Template Management
Clinical eTMF Trial Documents
eTMF Clinical Trial Document Processing
EDT Requirement Status
Create a Document from a Requirement
Document Expiration
Review Document from a Requirement
Approve Document
Reset Document
Revision Document
Clinical eTMF-EDT Guide
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Introduction
This document provides orientation on eTMF components and the EDT feature and how they interact within the Clinical eTMF solution.
EDT & eTMF Hubs
Learn how EDT and eTMF sites can help you to store and manage clinical trial workspace.
Clinical Trial Creation
Clinical eTMF-EDT allows the user to select a template on which to base the workspace and to apply the predefined security scheme.
Clinical eTMF Trial Documents
Use the Trial Master File structure to author and maintain clinical trial documents.