Clinical eTMF Guide
Introduction
Using this guide
Clinical eTMF Architecture
Package Deployment
Access Package Deployment
Definitions
Clinical eTMF Hub
Clinical eTMF Reference Lists
Reference List Population
Facilities Lists
Trial/Facility Relationship
Clinical Trial Workspace Template
Investigational Product List
Security and Notification Groups
Protocol Information View
Smart Document Feature
Clinical trial solution
Clinical Trial Workspace
Create a Clinical Trial Workspace
Access the New Clinical Trial Workspace
Clinical Trial Workspace Security and Notifications Groups
Investigational Sites (Facilities)
Investigational Site Locations
Clinical Trial Site Personnel
NextDocs Site Provisioning Timer
Clinical Trial Workspace Files
Trial Master File
CRO File Access
Clinical Trial Workspace Checklists
Trial Checklist Population
Country Checklist
Site Checklist
Master Lists
Clinical Trial Documentation
Create Document
Access Smart Document UI
Document Group
Additional Document Information
Completion
Document Permissions
Review Document
Review Completion
Workflow Overview
Review Audit Log
Review Termination
Approve Document
Skip to Final
Approval Completion
Document Approval
Document Rejection
Workflow Overview
Approval Audit Log
Audit Log for Document Approved
Audit Log for Document Rejected
Approval Workflow Termination
Demote Document
Demote Audit Log
Revision Document
Revision Audit Log
Auto Populate Feature
NextDocs Clinical Trial Workspace Template Creation
Create a Site Collection to be used as a Trial Workspace Template
Create the Site Collection Databases
Add the Template to the Multiple Site Collection Templates
Add the Clinical Trial Workspace Template to the Hub
Configure the Clinical Trial Workspace Template
Export the current site as a template to be used for provisioning
Add the template to the Hub site Workspace Templates list
Add the templates that will be used by Smart Document to create documents
Clinical eTMF Guide
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Introduction
Use this guide understand the components of the Clinical eTMF feature and how they interact within the baseline Clinical eTMF solution.
Clinical eTMF Hub
Learn how to use the clinical eTMF site to store and manage each clinical trial workspace.
Clinical trial solution
This section describes how to manage and use Clinical Trial workspaces, files and checklists.
Clinical Trial Documentation
Learn how to create, review, approve and manage all the documentation related to clinical trial.