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Appendix A: Shortcut Keys Available in Review

Amy Chen

This collection provides guidance on using the desktop-based GlobalSubmit Review application to evaluate eCTD and NeeS submissions. Topics include application access, document lifecycle review, annotations, reporting, file sharing, and navigation features—designed to mirror the regulatory agency’s view and streamline the submission review process.

Review (Desktop-Based) 

Basic Features of Review Introduction

Navigation Pane

Details Pane

Views Pane

Preview Pane

The interface is broken into to four panes: Navigation Pane, Details Pane, Views Pane, and Preview Pane

Basic Features of Review

Customize Review Introduction

Re-Size Panes

Auto Hide

Re-Position and Undock Preview Pane

Modify Preferences

Displayed Columns

Customize panes, review preferences, and columns

Customize Review

Reviewed Checkbox Information

Columns Available on Details and Inventory Tabs

Once files have been fully QC’d, the Reviewed column can be checked off.

Reviewed Checkbox

Filter Modules or Sequences

Filter by Content

Filter by Sequence

Filter by Regulatory Activity

By default, Review displays all modules and all sequences.

Annotations Introduction

Create Annotations

Search for Annotations

The Annotations tab allows you to enter comments about the submission.

Annotations

CrossCheck Introduction

Preview Pane in CrossCheck

The CrossCheck tab displays all bookmarks and links that are contained within files in the selected node and its subsections, from the Navigation pane. Each bookmark or link is displayed as a row.

CrossCheck

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