Certara.AI

Alondra Sandoval

This collection provides comprehensive guidance on assembling and publishing eCTD v3.3 and earlier submissions using the desktop-based GlobalSubmit Publish application. Topics include managing applications and sequences, structuring content, linking and bookmarking, validating submissions, and preparing compliant packages for delivery to regulatory authorities across multiple regions.

Publish (Desktop-Based) 

This section provides some general background and key concepts for using Publish.

Background

How to Use Publish Views and Live Validation in GlobalSubmit eCTD Suite for Efficient eCTD Submission Management

Publish and the GlobalSubmit Quality Suite

Understanding eCTD Applications, Sequences, and Regulatory Activities: A Guide to Efficient eCTD Submission Management

Applications – Sequences – Regulatory Activities

Understanding eCTD File Management: Files vs File References in Regulatory Submissions

Files and File References

Understanding eCTD File Management: Source Files vs Published Files in Regulatory Submissions

Architecture and File Transfer

Understanding eCTD States: Managing File and Section Status for Regulatory Submissions

States

Mastering Publish Functionality: Menus, Tabs, and Shortcut Keys for Efficient eCTD Submission Management

Usage Notes

Understanding eCTD Publishing Permissions and Workflow: Reserving Sections, Applying States, and Saving Changes

Summary of Key Points

Customizing Publish: Settings and Features for Efficient eCTD Compilation and Regulatory Compliance

Customize Publish

A Comprehensive Step-by-Step Guide to Creating a New Application

Create a New Application

Converting Existing Applications for Use in Publish: A Guide to Getting Started

Import an Existing Application

Managing Existing Applications in Publish: How to Open, Edit, and Update Properties

Modify Application Properties

How to remove an application from GlobalSubmit Publish Desktop

Remove an Application

How to manage applications within GlobalSubmit Desktop

Manage Applications

How to add a new sequence in GlobalSubmit Publish Desktop

Add a New Sequence

Streamlining Sequence Creation: How to Use Repeat Sections in Publish

Add Existing Repeat Sections

Opening and Modifying Existing Applications in Publish: A Step-by-Step Guide

Add a Grouped Submission

How to Edit Sequence Properties in Publish

Modify Sequence Properties

Editing Sequence Content in Publish: Understanding the Differences Between Origin, Life Cycle, and Current Views

Edit a Sequence

How to Place a Reservation on an In Progress Sequence or Section in Publish

Reverse for Edit

Conflict Resolution in Publish: Managing Multiple Users and Reservations

Manage Reservations

How to manage a sequence within GlobalSubmit Desktop

Manage a Sequence

Repeatable Sections and/or Studies

Add Application Metadata Repeatable Sections

Section Administration

Non-STF Study Node Extensions

Manage Content in a Sequence

Add File References

Modify Content

Move File References

Copy File References

Remove File References

Manage Lifecycle

Remove a Sequence

How to structure a sequence within GlobalSubmit Desktop

Structure a Sequence 

Upload Tab

How to save changes within GlobalSubmit Desktop

Save Changes

Link and Bookmark Window

Hyperlinks

Add Links

Delete Links

Edit Links

Move Links

Bookmarks

How to manage links and bookmarks within GlobalSubmit Desktop

Link and Bookmark Management

LINK in Publish

Process Changes in LINK in Publish

LINK Interface

Bookmarks by Font

Links from Current File

Page Layout

Import/Export References

Process PDF Metadata

Document Properties

Queue

How to manage links in Publish within GlobalSubmit Desktop

Publish to the File System

How to Publish and Validate a Sequence within GlobalSubmit Desktop

Publish and Validate a Sequence

How to manage states in GlobalSubmit Publish Desktop

Manage States

Managing File Reference States in eCTD Submissions: Understanding In Progress and Final States

File Reference State

Understanding Sequence States in eCTD Submissions: In Progress, Submission Ready, and Submitted

Sequence State

eCTD Regulatory Activity State Management: Best Practices for Managing the Submission Process

Regulatory Activity State

How to manage states within GlobalSubmit Desktop

Manage Standard File Reference Titles

How to manage Standard File Reference Titles within GlobalSubmit Desktop

Clone a Sequence

How to clone a sequence within GlobalSubmit Desktop

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