ToolBox 6.3 Help

ToolBox HelpVERSION 6.3

Disclaimer

This PDF document has been created from the Help file content that is accessed from within the software. This documentis provided for your convenience; however it is always best to check the Help file content from within the software for the

most current information. Additionally, some content may not have transferred as a perfect one-to-one match of the content in the Help file.An example of this is special characters such as customized bullets.

1. ToolBox Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.1.1 ToolBox Overview and Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.1.1.1 Text versus Image-Based Documents and Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

1.1.2 Common Features within the Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141.2 Bookmark Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

1.2.1 Bookmark Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211.2.2 Auto-Return Bookmark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301.2.3 Swap Bookmarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321.2.4 Expand and Shrink Bookmarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331.2.5 Bookmark Attributer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341.2.6 Bookmark Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361.2.7 Bookmark Master and Bookmark Master Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 421.2.8 iBookmark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

1.3 Hyperlink Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511.3.1 Text Quick Linker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511.3.2 Copy Link . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551.3.3 Inter-Document Linker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561.3.4 Keyword Linker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591.3.5 Link Attributer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 651.3.6 Page Linker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

1.4 Bookmark & Hyperlink Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 721.4.1 TOC Bookmarks & Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 721.4.2 Export & Import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 811.4.3 Delete Bookmarks and Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 841.4.4 iDestination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 861.4.5 Bookmark & Link Auditor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 911.4.6 QC Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

1.5 Image PDF Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1021.5.1 iEnhance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

1.5.1.1 Image Enhancement Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1091.5.2 iRedact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1121.5.3 Mask . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

1.6 Copy Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1211.6.1 ISICopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1211.6.2 ISICopy Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1231.6.3 ISICopy Graphic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

1.7 PDF Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1271.7.1 Add and Remove Blank Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1271.7.2 Browse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1281.7.3 Font Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1291.7.4 Goto Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1321.7.5 Hidden Text Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1351.7.6 iOptimize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1411.7.7 Page Stamper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1481.7.8 PDF Correct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1551.7.9 PDF Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1621.7.10 Save PDF As . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1701.7.11 Scale PDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1731.7.12 Search & Replace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

1.8 Advanced Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1851.8.1 EZPDF Maker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1851.8.2 Split PDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1891.8.3 Merge PDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1961.8.4 Page Mapper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1981.8.5 TOC Builder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2021.8.6 Rotation Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2121.8.7 PDF Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

1.9 eSubmission Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2191.9.1 Link LifeCycle Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2211.9.2 MD5 CheckSum Checker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2251.9.3 NeeS-ICH Verification Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2301.9.4 NeeS TOC Builder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

1.10 Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2501.11 Help & Setting Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

1.11.1 iBookmark Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2631.11.2 ISICopy Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2651.11.3 ToolBox Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2671.11.4 Customizing the Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

ToolBox 6.3 Help

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ToolBox Overview

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ToolBox OverviewTools

ToolBox OverviewToolBox™ is a plug-in application for Adobe Acrobat that is specifically designed to minimize and simplify time-consuming and repetitivetasks when working with PDF files. The collection of tools in ToolBox varies from PDF navigation to Bookmark and Hyperlink creation andmanagement to the use of text and graphic copying tools.

ToolBox also provides batch options, increasing the efficiency of working with multiple files. By utilizing the wide array of tools available inToolBox, many repetitive manual tasks are performed in a time-saving, automated process.

Tools

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There are four versions available for ToolBox, each targeting an industry or need. They are:

LegalPharmaProfessionalStandard

These versions vary only in the set of tools that come packaged with ToolBox. The table below identifies the tools that are included in eachversion.

For brief descriptions of each tool see the page.ToolBox Overview and Tools

Tool Group Tool Legal Pharma Professional Standard

Bookmark Tools Auto-Return Bookmarks x x

Bookmark Attributer x x x x

Bookmark Editor x x

Bookmark Master x x

Bookmark Master Batch x x

Bookmark Generator x x x x

Expand/Shrink Bookmarks x x x x

iBookmark x x x

Swap Bookmarks x x

Hyperlink Tools Copy Link x x x x

Inter-Document Linker x x x x

Keyword Linker x x x x

Link Attributer x x x

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Page Linker x x x x

Text Quick Linker x x x x

Bookmark & Hyperlink Tools Bookmark & Link Auditor x x x x

Delete Bookmarks & Links x x x x

Export/Import x x x x

iDestination x x x

TOC Bookmarks & Links x x x x

QC Viewer x x x x

Image PDF Tools iEnhance x x x

iRedact x x x

Mask x x x x

Copy Tools ISICopy x x x x

ISICopy Graphic x x x x

ISICopy Pages x x x x

PDF Tools Add/Remove Blank Pages x x x x

Browse x x x x

Font Manager x x x x

Goto Plus x x x x

Hidden Text Manager x x x x

Page Stamper x x x x

PDF Options x x x

iOptimize x x

Save PDF As x x

Scale PDF x x x x

Search & Replace x x x

Advanced EZPDF Maker x x

Merge PDF x x x x

Page Mapper x x x x

PDF Information x x

Rotation Manager x x x x

Split PDF x x x x

TOC Builder x x x x

eSubmission Tools Link LifeCycle Report x

MD5 CheckSum Checker x

NeeS TOC Builder x

NeeS/ICH Verification Check x

Batch x x x x

Help & Setting Tools iBookmark Preferences x x x

ISICopy Preferences x x x x

ISIToolBox Preferences x x x x

ToolBox 6.3 Help

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ISIToolBox ToolBar x x x x

ISIToolBox Help x x x x

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General Information

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About this Help ContentTypographical ConventionsAssumptionsContact CSC Regulatory Solutions GroupCopyright Notice

About this Help Content

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This help content is meant to be utilized as reference information. All ToolBox tools are described in detail and process examples areprovided to illustrate how each tool can be used. This help content does not provide the comprehensive instruction, however. A morethorough understanding of ToolBox tools and their uses can be gained by enrolling in one of our training courses. For more information,please email [email protected]

Typographical Conventions

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Bold body text within examples or descriptions indicates specific actions to be executed. (eg, Click the button.) It alsoStartcan specifiy a message, option, or function where adding the bold attribute helps to clarify the information.

Assumptions

This help information assumes that you are familiar with:

The basic operation of Microsoft Windows, Internet Explorer, and Adobe AcrobatUse of a mouse and standard menus and commandsManipulating applications and document windows on the screen

For help with any of these techniques, please refer to Microsoft and Adobe user documentation.

Contact CSC Regulatory Solutions Group

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Mail: CSC, 100 S. Jefferson Road Whippany, NJ 07981

Telephone: 973-560-0404

Training eMail: [email protected]

Support: (Note: This email address is in transition, however, this address can be used until notified otherwise.)[email protected]

Web: www.csc.com

Copyright Notice

Copyright © 2014 Computer Sciences Corporation, Inc. All rights reserved.

This help information (including the software featured in it) is furnished under license and may be used or copied only in accordance with the

http://www.csc.com

ToolBox 6.3 Help

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terms of such license. This help content is furnished for informational use only, is subject to change without notice, and should not beconstrued as a commitment by CSC.

CSC assumes no responsibility or liability for any errors or inaccuracies that may appear in this content. Except as permitted by such license,no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic,mechanical, recording, or otherwise, in whole or in part without the prior written permission of CSC. This restriction does not limit the right touse information contained in this help content, without restriction, if it is obtained from another source without restriction.

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ToolBox Overview and Tools

Page Content:

ToolBox OverviewTools

Tool DescriptionsAdobe Acrobat Compatibility and Accessing the ToolBox Tools

Accessing ToolBoxToolBox Tool Bar

ToolBox Overview

ToolBox™ is a plug-in application for Adobe Acrobat that is specifically designed to minimize and simplify time-consuming and repetitivetasks when working with PDF files. The collection of tools in ToolBox varies from PDF navigation to Bookmark and Hyperlink creation andmanagement to the use of text and graphic copying tools.

ToolBox also provides batch options, increasing the efficiency of working with multiple files. By utilizing the wide array of tools available inToolBox, many repetitive manual tasks are performed in a time-saving, automated process.

Each tool in ToolBox is easy to use, however, since many of the tools perform similar tasks, it may be a challenge to choose the tool that ismost efficient for the specific task. One suggestion is to have a basic understanding of each tool. The list of tools and descriptions on thispage provides this basic information. Click on the tool name to view more detailed information on that specific tool.

Tools

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There are four versions available for ToolBox, each targeting an industry or need. They are: * Legal* Pharma* Professional* Standard

See the page for a table that identifies the tools that are included in each version.ToolBox Overview

Tool Descriptions


-- Use this tool to automatically create bookmarks within one or more documents that link back to a singleAuto-Return Bookmarkfile. The Auto-Return Bookmarks tool was designed specifically to meet the Food and Drug Administration (FDA) requirements forelectronic submissions.

-- Use this tool to modify bookmark properties in the open PDF document. Additionally, settings in BookmarkBookmark AttributerAttributer can be saved as styles for later use.

Use this tool to add, modify, and delete bookmarks in a PDF document. Navigation tools in the dialog box allowBookmark Editor --for easy browsing within the document.

-- Use this tool to create bookmarks based on selected text (Bookmark by Font), a selected area (Bookmark byBookmark GeneratorArea), entered keywords (Bookmark by Keyword) or hyperlinks (Bookmark from Links) in a PDF document. To use Bookmark by

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Font, heading levels should be consistent throughout a document and unique from level to level. Keywords and selected text areascan also be used to create bookmarks. The Bookmark from Links option will use internal hyperlinks (hyperlinks with destinationswithin the same document) to create bookmarks. External hyperlinks (hyperlinks with destinations to another document) will beignored.

-- Use this tool to create bookmarks for patient data listings using keywords and selected areas. Additionally,Bookmark Mastersettings entered in this tool can be saved as an LST file, which can then be used in the Bookmark Master Batch to create bookmarksin multiple files simultaneously.

-- Use the LST file saved in the Bookmark Master tool to perform a batch bookmark process for similarBookmark Master Batchdocuments with the same bookmark settings.

-- Use this tool to expand or collapse of all bookmarks in the open PDF document. Save theExpand and Shrink Bookmarksdocument to retain the result of this action.

-- Use this tool to create bookmarks from selected text within a text-based or image-based PDF document. iBookmarkiBookmarkuses Optical Character Recognition (OCR) when used on an image-based document. See the iBookmark Preferences for settings tobe used with this tool.

-- Use this tool to switch the position of bookmarks in the hierarchy. Swap Bookmarks was designed to meet theSwap BookmarksFood and Drug Administration requirements for electronic submission of Case Report Forms (CRFs).

-- Use this tool to copy an existing hyperlink in the PDF document and paste it to other locations within the sameCopy Linkdocument. Hyperlink properties can be modified before pasting.

-- Use this tool to create hyperlinks to external files or web pages (URLs). By selecting an area of a page inInter-Document Linkerthe open PDF document, ToolBox will search that area on one or more pages and convert file paths and/or URLs found within theselected area to hyperlinks.

- Use this tool to create hyperlinks throughout a document by identifying keywords, specifying the destination andKeyword Linker -properties for each keyword, and specifying the page range that will be used to search for the keywords. The list of keywords and allthe associated settings can be saved and used to create hyperlinks in other documents.

-- Use this tool to modify hyperlink properties in the open PDF document to ensure that they are consistent inLink Attributer appearance. Once properties have been defined, they can be saved as a style and used in other PDF documents.

-- Use this tool to create a hyperlink around each page number by selecting an area of a page that will be scanned. ThePage Linkerdestination of each hyperlink will be the actual page number in the PDF document. For example, if number 29 is found during thescan, a hyperlink will be created with destination of page 29 in the open PDF document. This tool is typically used to createhyperlinks for a table of contents, index, list of tables, list of figures, etc.

-- Use this tool to quickly create individual hyperlinks in a PDF document by using the Adobe Acrobat Select TextText Quick Linkertool. Hyperlink destinations can be internal (within the same document), external (to another document), or to a web location.

-- Use this tool to audit, modify, spell check, and delete bookmarks and hyperlinks. The auditing feature isBookmark & Link Auditorused to ensure that destinations exist for the bookmarks and hyperlinks. The tool also provides the option to view the properties forselected bookmarks and hyperlinks.

-- Use this tool to remove bookmarks and/or hyperlinks from documents. Hyperlinks can be deleted onDelete Bookmarks and Linksall pages, the current page, or specified pages. It also can be used to delete only broken bookmarks and/or hyperlinks.

-- Use this tool to export or import bookmarks, hyperlinks and their attributes to/from a CSV or an Excel file. UsingExport & Importthis tool, bookmarks and hyperlinks can be easily modified in Microsoft Excel.

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-- Use this tool to generate named destinations from a PDF document's bookmarks or by entering the namediDestinationdestinations manually. Using named destinations points hyperlinks and bookmarks to specific content rather than a page number.This option ensures that destinations will remain accurate even if the content is moved to another page.

-- Use this tool to generate bookmarks from the table of contents (TOC) and hyperlink the entries in theTOC Bookmarks & LinksTOC.

-- Use this tool to validate bookmarks and hyperlinks. If invalid destinations are found or if properties are incorrect,QC Viewermodifications can be made directly in the QC Viewer dialog box.

-- Use this tool to improve the quality of image-based PDF documents by applying filters to correct specific image flaws.iEnhanceFilters can be customized and new filters can be created.

-- Use this tool to permanently black out or white out unwanted content from image and text-based PDF documents.iRedactAdditionally, this tool can be used to automatically find, redact and replace text in text-based PDF documents.

-- Use this tool to hide a selected area of a page without removing it permanently (whereas the iRedact tool removes contentMaskpermanently). Masked text can still be found using Search. Using the Show/Hide feature in the tool, selected text can be set todisplay in a different color.

-- Use this tool to copy a selected area of text from either a text-based or image-based PDF document. OCR technology isISICopyused to copy content from image-based documents. The text is copied to the clipboard and can then be pasted into any application.

-- Use this tool to copy content from a selected area as an image. Content can be copied from a text-based orISICopy Graphicimage-based PDF document. ISICopy Graphic copies data directly from the file instead of the screen, allowing for a higher resolutioncopy.

-- Use this tool to copy one or more pages of content from either a text-based or image-based PDF document. OCRISICopy Pagestechnology is used to copy content from image-based documents. The text is copied to the clipboard and then can be pasted intoany application.

-- Use this tool to delete or insert one or more blank pages in a PDF document. The tool will scan allAdd and Remove Blank Pagespages or a range of pages to remove blank pages in a document. Blank pages can be added by specifiying a location for the pages.

-- Use this tool to view each page within a PDF document. The amount of time that each page is displayed for is set in theBrowseToolBox Preferences.

-- Use this tool to display a listing of all fonts used in the open PDF document. The list will contain details such asFont ManagerPage Number, Type, Encoded standard, and if it is an Embedded Font. The information in the list can be exported as an Excel orCSV file format. This tool is useful when attempting to identify PDF files that may be problematic during the publishing process.

-- Use this tool to calculate the page offset when the PDF page number and paper page number do not match. This toolGoto Plusalso is used to browse through document pages.

-- Use this tool to delete hidden text from an image-based or text-based PDF document. Hidden text can beHidden Text Managerremoved by page, a selected area, or word by word.

-- Use this tool to convert a batch of PDF documents to a specified PDF version and optimize the files for fast web view.iOptimizeICH guidance specifies that PDF version 1.4 should be used for all submission documents. Often, when PDF documents originatefrom multiple sources, the PDF version may be different and files may not be optimized.

-- Use this tool to stamp page numbers or other desired text in the header of footer in a PDF document. This tool alsoPage Stampercan be used to stamp a watermark in the document.

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- Use this tool to correct damaged or malformed PDF files. Also known as "Refry."PDF Correct

-- Use this tool to modify document information fields in multiple documents at the same time. Custom informationPDF Optionsfields also can be added.

-- Use this tool to convert multiple PDF documents to a different file type (such as TIFF).Save PDF As

-- Use this tool to resize selected PDF document pages or to scale down the content. Scaling down the page content canScale PDFbe useful to ensure adequate margins. Resizing a page can be useful to change letter-size documents to A4-sized documents.

-- Use this tool to search for specified text in a PDF document and replace it with new text or a redactionSearch & Replacerectangle. All instances of one or several keywords can be replaced automatically or individually. This tool can be used on bothtext-based and image-based documents.

-- Use this tool to generate PDF files from a range of source file types. The tool identifies the source file by itsEZPDF Makerextension and uses Adobe Distiller to generate the PDF file. Converted files can be merged into a single PDF file or split intoseparate files.

-- Use this tool to combine multiple PDF documents into a single PDF document. Adjustments can be made to ensureMerge PDFthat existing bookmark and hyperlink destinations are still accurate after the merge.

-- Use this tool to map Roman numeral pages so that they can be recognized during hyperlinking and bookmarkingPage Mapperprocesses.

-- Use this tool to generate a report containing detailed information about multiple PDF files. This information can bePDF Informationexported to a CSV file. The CSV file can be viewed in other applications, such as Excel.

-- Use this tool to display the current orientation of a PDF file. This is useful when attempting to identify theRotation Managerorientation of image-based PDF files during the publishing process. It provides the capability to physically change the PDF pagerotation. The rotation information can be exported as an Excel or CSV file.

-- Use this tool to split a single PDF document into several individual PDF files based on level one bookmarks or a rangeSplit PDFof pages. Bookmark and hyperlink destinations are adjusted to ensure they maintain accuracy.

-- Use this tool to create a TOC for a single or batch of PDF documents. This tool is useful when working withTOC Builderdocuments that do not currently have a TOC or currently have an inaccurate TOC. For example, if several documents were merged,the existing TOC is out of date; TOC Builder can be used to create a new TOC.

-- Use this tool to locate broken lifecycle links in Japanese submissions.Link LifeCycle Report

-- Use this tool to check and update MD5 checksums without having to go back to an eCTD compilingMD5 CheckSum Checkersystem (such as eCTDXPress) to recompile an entire sequence.

-- Use this tool to create the overall and module TOCs for a NeeS submission.NeeS TOC Builder

-- Use this tool to ensure the files, folders, and paths in a selected submission are ICH compliant.NeeS-ICH Verification Check

-- Use this tool to perform one or more tasks across multiple files in a single process. Lists of tools and their settings can beBatchsaved and reused for further efficiency.

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-- Use this tool to set the options for the iBookmark tool.iBookmark Preferences

-- Use this tool to set the options for the ISICopy, ISICopy Graphic, and ISICopy Pages tools.ISICopy Preferences

-- Use this tool to set general options for ToolBox and for the Browse and Expand/Shrink tools.ToolBox Preferences

-- Use this tool to access the ToolBox help site.ISIToolBox Help

-- Use this tool to select the tools that will be included in the ToolBox toolbar.Customizing the Toolbar

Adobe Acrobat Compatibility and Accessing the ToolBox Tools


ToolBox is a plug-in application to Adobe Acrobat. ToolBox 6.3 is supported on Adobe Acrobat versions 9.5.2, 10.1.3, and 11. This version ofToolBox is not compatible with Acrobat version 8.x or earlier.

Once ToolBox has been installed, the tools can be accessed at any time simply by starting Adobe Acrobat. If ToolBox has not been installedyet, see the Installation Guide that is located with the product install files, for details on how to install ToolBox.

Accessing ToolBox


There are two ways to access ToolBox tools. All tools are accessible from the ToolBox menu or from the ToolBox tool bar. The ToolBox toolbar can be opened by clicking on the ToolBox icon on the Adobe Acrobat standard tool bar. Alternatively, click on the ToolBox menu, selectHelp & Settings Tools, and then ToolBox ToolBar.

ToolBox ToolBar Without a Document Open

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Opening the Tool Bar from the ToolBox Menu

ToolBox Tool Bar


Once the ToolBox tool bar is open, it can be moved to any convenient area of the screen. Individual tools *cannot* be undocked from theToolBox tool bar.

However, the tool bar can be customized to contain only the tools that you need. Click on the wrench icon located in the tool bar to select thetools to be included in the customized tool bar. The order of the tools can be changed, as well.

If there were no documents open when the ToolBox tool bar was opened, many of the tools will be disabled (as shown in the screen shotabove). When a PDF document is opened, all tools in the panel will be enabled (as shown in the screen shot below).

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ToolBox Tool Bar with all Tools Enabled

Text versus Image-Based Documents and Tools

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Page Content:

Distinguishing Between Text-Based and Image-Based DocumentsText-Based Versus Image-Based Tools Table

Distinguishing Between Text-Based and Image-Based Documents

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Text-based PDF documents are created in another software application, such as Microsoft Word, and then converted to PDF. In these typesof PDF documents, the text is searchable, it can be copied, and minor changes can be made to the content.

PDF documents that are image-based are created from a scan of a paper document (sometimes referred to as a scanned document).

Optical character recognition (OCR) can be run on image-based documents during or after the scanning process. When the OCR process isrun, an invisible layer is created that contains the converted text. Once the OCR process is completed the text is searchable, just as it is withan original text-based document. The ToolBox tools that are designed to work on text-based documents will also work on image-baseddocuments that have the OCR layer.

The PDF Information tool can be run on a document to determine if it is text-based or image-based. The information provided will also revealif the document contains a combination of text-based and image-based pages. Another method of determining if a document is text-based orimage-based is to select text using the Adobe Acrobat text selection tool. If this is possible, then the selected content is text-based. (Keep inmind, however, that some documents can be a combination of text-based and image-based content.)

Text-Based Versus Image-Based Tools Table

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The following table identifies the ToolBox tools that can be used on text-based documents, image-based documents, or both.

Tool Group Tool Text-Based Image-Based

Bookmark Tools Auto-Return Bookmarks x x

Bookmark Attributer x x

Bookmark Editor x x

Bookmark Master x

Bookmark Master Batch x

Bookmark Generator x

Expand/Shrink Bookmarks x x

iBookmark x x

Swap Bookmarks x x

Hyperlink Tools Copy Link x x

Inter-Document Linker x

Keyword Linker x

Link Attributer x x

Page Linker x

Text Quick Linker x x

Bookmark & Hyperlink Tools Bookmark & Link Auditor x x

Delete Bookmarks & Links x x

Export/Import x x

iDestination x x

TOC Bookmarks & Links x

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QC Viewer x x

Image PDF Tools iEnhance x

iRedact x x

Mask x x

Copy Tools ISICopy x x

ISICopy Graphic x x

ISICopy Pages x x

PDF Tools Add/Remove Blank Pages x x

Browse x x

Font Manager x

Goto Plus x x

Hidden Text Manager x

Page Stamper x x

PDF Correct x x

PDF Options x x

iOptimize x x

Save PDF As x x

Scale PDF x x

Search & Replace x

Advanced EZPDF Maker N/A N/A

Merge PDF x x

Page Mapper x

PDF Information x x

Rotation Manager x x

Split PDF x x

TOC Builder x x

eSubmission Tools Link LifeCycle Report N/A N/A

MD5 CheckSum Checker N/A N/A

NeeS TOC Builder N/A N/A

NeeS/ICH Verification Check N/A N/A

Batch N/A N/A

Help & Setting Tools iBookmark Preferences N/A N/A

ISICopy Preferences N/A N/A

ToolBox Preferences N/A N/A

ToolBox ToolBar N/A N/A

ToolBox Help N/A N/A

N/A = Not Applicable

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Common Features within the Tools

Page Content:

Dialog BoxesHyperlink PropertiesMarginsPage Justification

Dialog Box OptionsDestination Action TypeDestination Page

ButtonsArrowsAdd Files Button / Add Directory Buttons and IconsModify ButtonDelete, Delete All, Remove, Remove All, Remove Files ButtonsSort FilesExport, Save, Save As, Save Config., Save List ButtonsImport, Load, Load Config., Load List, Open ButtonsEllipsis ButtonHelp Button

Many of the ToolBox tools have various buttons, options, or actions in common, the majority of which work in the same manner regardless ofthe tool.

Dialog Boxes

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Bookmark Properties Dialog Box

Click the button to select a bookmark appearance and the magnification of the bookmark’s destination page. In someBookmark Propertiesdialog boxes, these options are found within the main dialog box instead of being accessed through a button.

Some of the dialog boxes where Properties can be found are:

Bookmark GeneratorBookmark MastesTOC Bookmarks & Links

Appearance Group Box

Style - Select a font style for the bookmarks from this drop-down list. The options are Plain, Italic, Bold, and Bold & Italic.Color - Select a font color for the bookmarks from this drop-down list.

Action Group Box

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Magnification -- Select an option from this drop-down list to set the magnification at which the bookmark’s destination page willopen. The options are Fit Height, Fit Page, Fit View, Fit Visible, Fit Width, Fixed, and Inherit Zoom. It is recommended to set themagnification to Inherit Zoom. This opens the destination page to the same magnification level set for the original page and isrecommended by ICH guidance. As a result, an agency reviewer (or anyone else viewing the document) can avoid havingto continually modify the zoom settings.Open In – This drop-down box is enabled when the bookmark destination is to an external document. Auto-Return Bookmark andBookmark Attributer will have this option enabled. The selection from this drop-down list will determine if the bookmark’s destinationfile will open in the same Acrobat window or a new window. The options are:

Window set by user preference: This option will open the destination file based on the information selected in AdobeAcrobat’s Preferences dialog box.New Window: This option will open the destination file in a new window when the bookmark is clicked.Existing Window: This option will open the destination file in the same window as the source document when thebookmark is clicked.

Hyperlink Properties

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Click the hyperlink Properties button to set the appearance and action for the hyperlink. Note that the button also may be labeled LinkProperties.

The hyperlink Properties dialog box title bar will reflect the dialog box from which it was selected. Some of the dialog boxes wherehyperlink Properties can be found are:

Text Quick LinkerCopy LinkInter-Document LinkerKeyword LinkerPage LinkerTOC Bookmarks & Links

Appearance Group Box

Line Type – Select the hyperlink border. The choices are Visible Rectangle or Invisible Rectangle. If Visible Rectangle is selected,the Line Style, Line Thickness, and Color options will be enabled.Highlight Style – Select how the hyperlink appearance should change when it is clicked. The choices are: None, Invert, Outline, orInset.Line Thickness – When Visible Rectangle is selected as the Line Type, select a width for the hyperlink border. The choicesare: Thin, Medium, or Thick.Line Style – When Visible Rectangle is selected as the Line Type, select a style for the line. The choices are: Solid, Dashed, orUnderlined. The selection of Underlined will only place a line below the hyperlinked content, a complete border will not display.Color – When Visible Rectangle is selected as the Line Type, select a color for the hyperlink border.

Action Group Box

Magnification – Select an option from this drop-down list to set the magnification at which the hyperlink’s destination page will open.The options are Fit Height, Fit Page, Fit View, Fit Visible, Fit Width, Fixed, and Inherit Zoom. It is recommended to set themagnification to Inherit Zoom. This opens the destination page to the same magnification level that has been set for the original pageand is recommended by ICH guidance. As a result, an agency reviewer (or anyone else viewing the document) can avoid having tocontinually modify the zoom settings.Open In – This drop-down box is enabled when the hyperlink destination is to an external document. The selection from thisdrop-down list will determine if the hyperlink’s destination file will open in the same Acrobat window or a new window. The optionsare:

Window set by user preference: This option will open the destination file based on the information selected in AdobeAcrobat’s Preferences dialog box.New Window: This option will open the destination file in a new window when the hyperlink is clicked.Existing Window: This option will open the destination file in the same window as the source document when the hyperlinkis clicked.

Margins

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Click the button to set the distance from the text to the border. This is only necessary when Visible Rectangle is selected as the LineMarginsType in the Properties dialog box.

The Margins dialog box title bar will reflect the dialog box from which it was selected. Some of the dialogs where Margins can be found are:

Text Quick LinkerCopy LinkInter-Document LinkerKeyword Linker

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Page LinkerTOC Bookmarks & Links

Page Justification

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The options in this dialog box are used to position in which the bookmark's or hyerplink's destination page will display.

Page Justification Dialog Box

Do not use Page Justification – Select this radio button to apply the default Adobe page alignment to display the bookmark's orhyerplink's destination page. This is the default setting.Left Edge of Page – Select this radio button to position the bookmark'sor hyerplink's destination page at the left edge of the viewingwindow.Leftmost Item – Select this radio button to position the bookmark'sor hyerplink's destination page to display the left most element onthe page aligned with the left edge of the viewing window.Leftmost Text – Select this radio button to position the bookmark'sor hyerplink's destination page to display with the left most textaligned with the left edge of the viewing window.Right Edge of Page -- Select this radio button to position the bookmark'sor hyerplink's destination page to display at the right edgeof the viewing window.Heading Text -- Select this radio button to position the bookmark's or hyerplink's destination page to display with the first headingstyle text aligned to the left edge of the viewing window.

Dialog Box Options

Destination Action Type

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Select an option from this drop-down list to specific the destination document of the bookmark or hyperlink. These options are availabe inboth bookmarking and hyperlinking tools.

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Action Type Options

Goto View Internal - Select this option to set the destination to a location within the same document.Goto View External - Select this option to set the destination to a location within another PDF document. If this option is selected,the Destination File (also labeled File) field will be enabled so that the file can be selected. Click the adjacent ellipses (...) button toselect the destination file. The Destination Page can also be selected.Open File - Select this option to set the destination to a non-PDF document (such as an XPT or DOC file). If this option is selected,the Destination File (also labeled File) field will be enabled so that the file can be selected. Click the adjacent ellipses (...) button toselect the destination file. The Destination Page options will not be available. Page 1 of the destination document will open when thebookmark or hyperlink is clicked.Web Link - Select this option to set the destination to a web address. If this option is selected the File field converts to a URL field.Type or copyand paste a URL (web address) into the field.None - Select this option to disable the destination options.

Destination Page

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The selected option is used to determine the bookmark's or hyperlink's destination page. These options are availabe in both bookmarkingand hyperlinking tools. However, the Use Bookmark option is not included in bookmarking tools.The options enabled in this group box aredependent upon the selection made in the Type drop-down list.

Destination Page Options

Current Page - Select this radio button to set the destination page to the currently displayed PDF page. If the Action Type is set toGoto View External, the Current Page option will be disabled.Use Page Number - Select this radio button to set the destination page to a specific page number. The page number is entered inthe adjacent text field.Use Named Destination - Select this radio button to set the destination page to a named destination. If this option is selected, theadjacent ellipsis (...) button is enabled. Click the ellipses button to display a list of the named destinations. If Goto View External wasselected as the Action Type, then the named destinations from the destination document will be displayed. Named destinationsare creeated with the tool.iDestinationUse Bookmark - Select this radio button to set the destination page using the bookmarks in the document. If this option is selected,the adjacent ellipsis (...) button is enabled. Click the ellipses button to display the list of document bookmarks. If Goto View Externalwas selected as the Action Type, then the bookmarks from the destination document will be displayed.

Buttons

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Arrows

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In many of the tools in ToolBox there are arrow buttons that allow for rearrangement of the contents of a list box. The majority of thesearrows work in the same manner regardless of the tool. In some cases the file order is a consideration, such as in the Merge PDF tool. Theorder in which the files are listed will determine the order in which the content will display in the merged file. The TOC Builder is a tool wherefile order is important. In TOC Builder, the order in which the files are listed will determine the content order in the TOC.

When a file is selected, the arrow buttons will be enabled. Use the arrow buttons to move the files around in the list box.

First – Click this button to move a selected file to the top of the list.

Up – Click this button to move a selected file up one place in the list.

Down – Click this button to move a selected file down one place in the list.

Last – Click this button to move a selected file to the bottom of the list.

Add Files Button / Add Directory Buttons and Icons

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In most dialog boxes that utilize the Add Files/Add Direcotry funtion, there are buttons that are used. However, in the updated Batch tool, thebuttons have been replaced with the File and Directory icons.

Click the button or icon to navigate to a directory and select one or more files from within that directory.Add Files

Click the button to navigate to and select a specific directory that contains the files that are needed. All of the files from theAdd Directorydirectory will be loaded in this step. Individual files can be removed once they have been loaded by selecting them from the list and clickingthe or button or icon. Delete Remove

Modify Button

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When an item in a list in a dialog box is selected the selected options for that item will be populated. If options are changed, the Modify buttonwill be enabled. Click the Modify button to save the changes.

Delete, Delete All, Remove, Remove All, Remove Files Buttons

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The Delete or Remove button will be enabled when a list item in a dialog box is selected. Click the button to remove that item from the list.

Click the Delete All, Remove All, or Remove Files button to remove all items from the dialog box list.

Sort Files

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Click this button to arrange the list in alphabetic order.

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Export, Save, Save As, Save Config., Save List Buttons

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Click any of these buttons to save the content or selections to a LST or CSV file. The information and settings saved in these files can beused to bookmark or hyperlink other documents, and also can be shared with other ToolBox users.

Import, Load, Load Config., Load List, Open Buttons

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Click this button to load a previously saved list of documents or settings. The settings or information are stored as LST or CSV files. Onceloaded, changes can be made to the list or settings.

Ellipsis Button

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Click this button to launch a sub-dialog box within a main dialog box.

Help Button

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Click the button to open the product help web site to the page with information on the active dialog box (referred to as context-sensitiveHelphelp).

Online Help Login Window

The online help index file (TBXHELPWEB.dat) is installed in ToolBox plug in folder; usually <Acrobat Folder>\Acrobat\plug ins\CSC)

However, if the online help page is not reachable due to internet access or any other reason, the following error message will appear, and thelocal help file will opened in the web browser.

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Online Help File Unavailable

Local Help File

The default location of the local help file (ToolBox 6.3 Help.pdf) is ToolBox Core install folder, usually <Program Files>\CSC\ToolBox.

Bookmark ToolsThe tools described in this section are the basic bookmarking tools in ToolBox. Using the bookmarking tools significantly reduces the lengthyprocess of manual bookmarking in text-based and image-based PDF documents.

The tools included in this section are:

Bookmark GeneratorAuto-Return BookmarkSwap BookmarksExpand and Shrink BookmarksBookmark AttributerBookmark EditorBookmark Master and Bookmark Master Batch

Either click on a hyperlink above or use the navigation pane to access details on each tool.

Bookmark Generator

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Page Content:

AccessOverview

Bookmark by FontBookmark by AreaBookmark from LinksBookmark by Keyword

Examples:Creating Bookmarks by FontCreating Bookmarks by Area

DetailsFont PropertiesPage JustificationAdvanced OptionsDestination Editor View Option Summary

Access

ToolBox > Bookmark Tools > Bookmark Generator

Or

Overview

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Use this tool to create bookmarks in a PDF document based on selected text (Bookmark by Font), a selected area (Bookmark by Area),entered keywords (Bookmark by Keyword), or hyperlinks (Bookmark from Links).

Up to ten levels of bookmarks can be defined and created using Bookmark Generator. The method of creating bookmarks can be selectedfor each level and options can be selected for the bookmarks (ie, to display expanded or collapsed).

This tool can be used in mode.Batch

Bookmark by Font

Bookmark by Font is used to create bookmarks from document headings. This is typically done when the document does not have a table ofcontents (TOC). If the document has a TOC that represents the heading levels in the document, then it may be best to use the TOC

tool to create bookmarks.Bookmarks & Links

Bookmark by Font is best used when the heading level attributes are consistent throughout a document yet unique from level to level.Bookmark by Font also can be applied when heading level attributes are the same from level to level, but section numbers can be used asthe unique identifier (see below).Advanced Options

If using section numbers, only one level of bookmarks can be created.

Below is an example of heading levels that are consistent throughout a document yet unique from level to level:

Heading Level 1 = Arial, 12 pt, black, upper caseHeading Level 2 = Arial, 12 pt, black, initial capsHeading Level 3 = Arial, 11 pt, black, initial capsHeading Level 4 = Arial, 10 pt, black, initial caps

This scenario is well suited for creating 4 levels of bookmarks that mimic the four heading levels.

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If the content in the header or footer of the document matches a font combination that was identified for bookmarking, SetExclusion Area in the Advanced Options dialog box can be used to exclude these areas from the process.

Bookmark by Area

The Bookmark by Area option is best used when the content to be bookmarked is in the same location on all or most pages in thedocument. Bookmark by Area uses the content within a selected page area to create bookmarks. A designated page range or all pages canbe selected.

For pharmaceutical documents, this option is well suited for electronic CRFs or CRFs that have been scanned with optical characterrecognition (OCR) and have the Domain and Visit information located in the same area on all pages. This tool then can be used incombination with Swap Bookmarks to create the By Domain and By Visit bookmark structure.

Bookmark from Links

The Bookmark from Links option uses internal hyperlinks (hyperlinks with destinations within the same document) to create bookmarks.External hyperlinks (hyperlinks with destinations to a separate document) are ignored.

Use the Bookmarks from Links option to help with performing qualitiy control checks on the table of contents hyperlinkdestinations. For example, if QC'ing of TOC hyperlink destinations is needed, create bookmarks from the TOC links. Thebookmark destination will then mimic the TOC hyperlink destinations. To QC, simply click on each bookmark to verify thedestination.

Bookmark by Keyword

The Bookmark option uses specified words to create bookmarks. The document will be searched for those keywords and bookmarks will becreated for each instance of the word.

Once bookmarks have been created using one or more of these options, other tools ( or ) may be used to adjust theBatch Bookmark Editorbookmarks as needed.

Bookmark Generator can be used on text-based documents or documents that have been scanned with OCR.

Once Bookmark Generator is used, the settings will be maintained the next time the dialog box is opened. The individualsettings can be changed as needed or click the Reset Level Information button to remove all settings.

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Bookmark Generator Dialog Box

Examples:

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Creating Bookmarks by Font

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Select an appropriate level from the drop-down list. The selection determines the maximum number of bookmark levelsMax Levelthat can be created for the current document.Ensure is selected from the drop-down list. Levels contained in the Select Level drop-down list will match theLevel 1 Select Levelnumber of levels selected in the Max Level drop-down list.Select the radio button. The Font Information list box, Font Properties, Add Font, and Delete Font buttons willBookmark by Fontactivate and the cursor will change into a select tool.In the open PDF document, highlight the text to be used to create first level bookmarks. The highlighted text should berepresentative of other same level headings, in terms of font name, size, color and case.Click the button. The selected heading's font, color, case, and size will be added to the Font Information list as theAdd Fontattributes that will be used to identify content that will be used to create level 1 bookmarks.

Some font specifics can be set to include the use of bolded text or a height tolerance. See the below for moreNote: Font Propertiesdetails.To add additional font combinations that should be used to create level 1 bookmarks, repeat steps 4 and 5 until all have been addedto the list.Select from the drop-down list. The Font Information list box will refresh so that different font information can beLevel 2 Select leveladded.Ensure the radio button in selected.Bookmark by FontHighlight the text to be used to create second level bookmarks (bookmarks that will be indented in the bookmark structure). Thehighlighted text should match other headings at the same level in terms of font name, size, color, and case, but it cannot be thesame as level 1 bookmark text style combinations.Click the button. The selected heading's font, color, case, and size will be added to the Font Information list as settingsAdd Font

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that will be used to to identify content that will be used to create level 2 bookmarks.Click the button and select Style, Color, and Magnification settings. Click the button. The selectedBookmark Properties OKproperties will be applied to all bookmark levels in the current PDF document.Click the button. The Bookmark Generator - Advanced Options dialog box will open, providing options that canAdvanced Optionsbe applied to all bookmark levels. Options such as excluding specific areas of the page, using the Destination Editor and deleting oldbookmarks can be selected in the Advanced options. (See below for details on each option.) Click the buttonAdvanced Options OKwhen done selecting options.Select the . This selection determines which pages in the document will be scanned for the font combinations. TypicallyPage Rangethis will be .AllSelect a option. Selecting None will arragne the bookmarks in the order in which they appear in the document.Sort bySelect a option. If selecting Expand also specify the level to which the bookmarks should be expanded.StructureClick the button. Bookmark Generator will search the document for the specified font information and create bookmarksStartaccordingly. Upon completion, the Bookmark Generator dialog box will close.

All selections made will be maintained the next time the dialog box is opened. Click on the button toView Option Summaryreview the selections before creating bookmarks.

If intending to use these same options for additional documents, click the button to save the information. SeeSave Configthe page for more details.Common Features

Creating Bookmarks by Area

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Select an appropriate level from the drop-down list. The selection determines the maximum number of bookmark levelsMax Levelthat can be created for the current document.Ensure is selected from drop-down list.The levels contained in the Select Level drop-down list will match theLevel 1 Select Levelnumber of levels selected in the Max Level drop-down list.Select the radio button. The Select Area button will be enabled.Bookmark by AreaClick the button. The Bookmark Generator dialog box will temporarily close and the cursor will turn into the AreaSelect AreaSelection tool.Using the tool, draw a rectangle around the area of the page that will be used to create bookmarks. The BookmarkArea SelectionGenerator dialog box will reopen and all text residing in the selected area will be used to create bookmarks. The coordinates for theselected area will be displayed in the Left, Top, Right, and Bottom fields.Repeat steps 2-5 for each bookmark level.Click the button and select the Style, Color, and Magnification settings. Click the button. The selectedBookmark Properties OKproperties will be applied to all bookmark levels in the current PDF document. (See the page for more details onCommon FeaturesBookmark Properties.)Click the button. The Bookmark Generator - Advanced Options dialog box will open, providing options that canAdvanced Optionsbe applied to all bookmark levels. Options such as excluding specific areas of the page, using the Destination Editor and deleting oldbookmarks can be selected in the Advanced options. (See below for details on each option.) Click the buttoAdvanced Options OKn when done selecting options.Select the . Selecting a page range or All means the content within the same area on all specified pages will be used toPage Rangecreate bookmarks.Select a option. Selecting None willarragne the bookmarks in the order in which they appear in the document.Sort bySelect a option. If selecting Expand also specify the level to which the bookmarks should be expanded.StructureClick the button. The text appearing in the selected area on the selected page(s) will be used to create bookmarks. UponStartcompletion, the Bookmark Generator dialog box will close.Repeat this process to create additional levels of bookmarks.

Details

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Font Properties

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At times selected font information may required additional parameters set to ensure content is picked up accurately throughout thedocument.

For example, a font that is not embedded in the document may not be picked up to be bookmarked. However, making the proper selectionsin this dialog box will ensure that the font will be recognized for bookmark. Another example would be a case where all document headingsare not formatted consistently (ie, one may have been italicized). Once again, making the right selections in this dialog box will compensatefor these inconsistencies.

Font Properties can be set for each bookmark level. Remember, when selections are made in the Bookmark Generator dialog box, they aremaintained the next time the dialog box is open. Since settings are maintain for the next use, it is good practice to check these settings toensure they are still applicable.

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Bookmark Generator - Font Properties Dialog Box

Typface Name Matching -- If fonts are not embedded in the PDF document, bookmarking content by exact font parameters may notpractical. In these cases, looking for partial font name information, or no font information, and then keying on a specific Font Propertywill help to create the proper bookmarks.

Exact – This is the default setting. When this radio button is selected, only content that matches the font face attributes willbe bookmarked.Partial – If the heading's font face varies, select this radio button to bookmark content that partially matches the font faceattribute (eg, if "Arial-Bold" is the font face attribute, selecting Partial will result in all "Arial" text being bookmarked). Ifselected also select a Font Property to focus the search for font attributes.None – If the font face varies greatly, select this radio button to exclude use of the font face in bookmarking content. Ifselected also select a Font Property to focus the search for font attributes.

Font Properties – When there is some variation in heading styles or if the Partial or None options are selected in Typeface NameMatching, one or more of these options can be selected to ensure that the accurate content is picked up to be bookmarked.

Height – Select this check box to use font height as a key attribute in the search for content to bookmark. This also can beselected if a height variance is necessary. Since the height may vary from heading to heading due to adjustments madeduring PDF conversion, scanning, or OCR, a Height Tolerance can be entered in the edit box below the Font Properties tocompensate.Bold -- If the selected font attributes do not include bold, yet the document contains some bold headings, this check box canbe selected to include the bold attribute in the search parameters. (This can also be used in combination with the TypefaceName Matching option – Partial.) For example, if the selected heading uses Verdana, 12 pt, Bold, yet this is not anembedded font, then Partial and Bold can be selected to ensure the headings are captured for bookmarks.Italic - If the selected font attributes do not include italics, yet there are some headings in the document that are in italics,this check box can be selected so that the search will include the italic attribute.Color – If the selected font attributes identify black as the font color, yet some headings in the document are in anothercolor, this check box can be selected so the search will include headings regardless of font color.Uppercase – If the selected font attributes specifiy that the headings are in initial caps, yet there are some headings in thedocument that are in all uppercars, this check box can be selected so that the search will include the font style if is appearsin all uppercase.

Additional Options -- These options are used to specify some extra information on the content that should NOT be bookmarked.Allow some blank lines in the heading – At times the document headers may have an extra carriage return before or aftercontent that should be bookmarked. Select this check box to create a single bookmark for headings that include blank linesup to the number selected in the adjacent drop-down list. The blank carriage returns will be ignored. (Note that all lines mustbe in the same heading style to be recognized as one heading.) If this check box is not selected, a blank bookmark will becreate for each line.Apply exclude list -- There may be content in the document that should not be bookmarked even though it uses the sameset of attributes used for headers. An example may be a table heading. Select this check box to enable the Exclude listbutton. Click the Exclude list button to open the Bookmark Generator - Exclude List dialog box. Use this dialog box to enterthe words that should be excluded from the bookmarking search process.

Page Justification

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The options in this dialog box are used to position in which the bookmark's destination page will display.

Bookmark Generator - Page Justification Dialog Box

Do not use Page Justification – Select this radio button to apply the default Adobe page alignment to display the bookmark'sdestination page. This is the default setting.Left Edge of Page – Select this radio button to position the bookmark's destination page at the left edge of the viewing window.Leftmost Item – Select this radio button to position the bookmark's destination page to display the left most element on the pagealigned with the left edge of the viewing window.Leftmost Text – Select this radio button to position the bookmark's destination page to display with the left most text aligned withthe left edge of the viewing window.Right Edge of Page -- Select this radio button to position the bookmark's destination page to display at the right edge of the viewingwindow.Heading Text -- Select this radio button to position the bookmark's destination page to display with the first heading style textaligned to the left edge of the viewing window.

Advanced Options

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The options in this dialog box are used to apply specific settings to all bookmark levels.

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Bookmark Generator - Advanced Options Dialog Box

Remove section numbers from bookmarks – If the document headings contain section numbers not wanted in the bookmarkstructure, select this check box to ensure that bookmarks will not include those section numbers.Ignore adjacent repeated headings – If a section in the document is continued on one or more pages, the heading may berepeated. If the heading is not to be repeated in the bookmark structure, select this check box to ignore text that already has beenbookmarked at the same level.Also ignore non-adjacent repeated headings – At times a document heading may be repeated as a sub-heading (eg, headinglevel 2). This check box is selected to prevent this content from being identified as both a level 1 bookmark and a level 2 bookmark.This option will ignore text that already has been bookmarked on any level.Use destination editor -- Select this check box to open the Bookmark Generator - Destination Editor dialog box prior to completingthe bookmarking process. Bookmarks can be reviewed and edited before they are created and added to the document. See Destinat

below for more details.ion EditorUse absolute path -- Select this check box to use the bookmark's absolute path for auditing purposes instead of its relative path.When Use absolute path is selected and a bookmark's destination is changed, it will appear as a broken link in the Bookmark & LinkAuditor dialog box.Use section numbers to match headings – Select this check box to determine the bookmark hierarchy based on section numbersin the heading text. This feature is typically used when the font attributes for each heading level are nearly identical and only onelevel can be set in Bookmark Generator. For example, if heading levels 1 through 4 are all using Arial, 14 pt Bold, then BookmarkGenerator is unable to distinguish the bookmark hierarchy from the font attributes alone. By selecting this check box, the sectionnumber in the heading text (eg, '2.1' in the heading '2.1 Statistical Methods') will be used to determine the bookmark level whencreating bookmarks.Delete old bookmarks before creating new ones -- Select this check box to override existing bookmarks with the newly createdbookmarks. If this is not selected, bookmarks created with Bookmark Generator will be added to bookmarks that already may exist inthe document.Show bookmark pane when document opens – Select this check box to display the Bookmarks pane when the PDF file isopened.Select Area -- Select this check box to include or exclude a selected page area during the bookmarking process. An example whenexclude would be used is if fonts used in the document headers and footers match the fonts selected to create the bookmarks. Usingthe buttons in the Select Area group box, the area of the page can be selected to be excluded.Include/Exclude Area -- Select one of these radio buttons to specify an area of the page (or pages) to include orexclude (respectively) during the bookmarking process. Once a selection is made, the Select Area1 button will be enabled.Select Area1 – Click this button to select an area of the page to include or exclude. The Bookmark Generator dialog box willtemporarily close and the cursor will turn into an area selection tool in order to select an area on the page. Once the area is selected,the Bookmark Generator dialog box will reappear, and the coordinates of the selected area will appear in the Left, Right, Top, andBottom fields.Select Area2 -- If it is necessary to include or exclude another area of the page, select the check box adjacent to the Select Area2button. Click the button to include or exclude another area of the page.

Destination Editor

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When using Bookmark Generator, it may be good practice to review the bookmarks prior to committing them to the document. TheDestination Editor is a selectable Advanced Option.

Once the Bookmark Generator Start button is clicked, the document is scanned searching for content to bookmark. If this option is selected,prior to completing the process and placing the bookmarks in the bookmark pane, the Destination Editor dialog box will open.

In the Destination Editor dialog box there are options to change the title, destination action (Goto View Internal, Goto View External, etc.),destination page, and bookmark properties, delete a bookmark, and add bookmarks.

All of the features in this dialog box work in the same manner as they do in the stand-along Bookmark Editor tool. See the tBookmark Editorool for all details.

To check the destination, double-click on the bookmark in the Destination Editor dialog box. The document will jump to thebookmark's destination.

Bookmark Generator - Destination Editor Dialog Box

View Option Summary

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The View Option Summary provides a view of the bookmark attributes that have been selected.

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Bookmark Generator Setting Summary

Auto-Return Bookmark

Page Content:

AccessOverviewExample

Adding a Return Bookmark to Multiple Files

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ToolBox > Bookmark Tools > Auto-Return Bookmarks

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Overview

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Use this tool to automatically create an external bookmark within one or more documents that link back to a specific file. For example, thesame bookmark can be created in ten separate files that all navigate to a common table of contents. By default, an Auto-Return Bookmark isplaced above existing bookmarks.

The Auto-Return Bookmarks tool was designed specifically to meet the Food and Drug Administration (FDA) requirements for electronicsubmissions (eNDA, eBLA, eIND).

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Pharma Requirement: The CBER division of the FDA requires that all files within an electronic submission havebookmarks navigating back to the main table of contents, the section table of contents and the Roadmap. (ie, Within AutoReturn Bookmark, select the files within the Clinstat folder and set one bookmark to the Clintoc and the other to theBLATOC. Once the individual items have been completed, the entire submission will need a bookmark to the Roadmap.)Note that this is not necessary for submissions in the eCTD format.

Auto-Return Bookmark Dialog Box

Example

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Adding a Return Bookmark to Multiple Files

Click the button. The Browse for Folder dialog box will open, where the folder containing the files needing bookmarksAdd Directorycan be selected.Browse to and select the appropriate folder, then click the button. The Browse for Folder dialog box will close and the path to theOKfiles will be populated in the Files list box.

Click the button to arrange the files in the list in alpha-numeric order.Sort Files

Enter a bookmark title in the field, such as Roadmap.TitleClick the button next to the File field. The Auto-Return Bookmark - Browse File dialog box will open, where the desired destination...document can be selected.Browse to and select the desired destination document, then click the button. The dialog box will close and the document'sOpenpath will appear in the File field.

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Select the check box. This option will overwrite the existing bookmark in the specifiedOverwrite if same bookmark name existsfiles that have the same name as the new bookmark.Click the button. The Bookmark Properties dialog box will open, where the appearance and magnification of bookmarkPropertiestitle can be specified. (See the pages for more details on Bookmark Properties.)Common FeaturesSelect the desired attributes and then click the button. The Bookmark Properties dialog box will close.OKClick the button. The bookmark will be added to the list. Note that if an existing bookmark is selected from the list, this button isAddlabeled as Modify. If changes are made to the selected bookmark (eg, change of title), clicking the Modify button saves the changes.Click the button. Bookmarks to the destination document will be created in all specified files and the dialog box will close. Start

Swap Bookmarks

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ToolBox > Bookmark Tools > Swap Bookmarks

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Overview

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Use this tool to switch and reorganize bookmark positions in the bookmark hierarchy. Swap Bookmarks was designed specifically to meetFood and Drug Administration (FDA) requirements for Case Report Forms (CRFs) that are included in electronic submissions.

Pharma Guidance: The FDA prefers to receive CRFs with bookmarks organized in both By Visit and By Domain structure.

Since CRFs are ordered chronologically according to Visit date, it is easier to first create By Visit bookmarks using or iBookmark Bookmark, and then use Swap Bookmarks to create the By Domain structure.Generator

This tool also can be used in mode.Batch

Swap Bookmarks Dialog Box

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Example

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This example assumes that the By Visit bookmark structure has already been created and that each Domain has been set up as a child levelbookmark under each visit (As shown in the left half of the screenshot below.)

Example of By Visit Bookmarks Swaped to Create By Domain Bookmarks

Select the radio button. This will swap the level two and level three bookmarks. As an example, VISIT 1 isSwap level 2 and level 3a level 2 bookmark in the By Visit bookmark structure shown above and BACKGROUND INFORMATION is a level 3 bookmark.If desired, select the check box and enter the bookmark destination page number inSelect page number for the root bookmarkthe adjacent field. If this check box is not selected, the root bookmark destination will be the same as the first child bookmark.Click the button to set the bookmark appearance. See the page for details on bookmark properties.Properties Common FeaturesSelect the check box and enter a title, such as BY DOMAIN, in the adjacent field. This will group the newlyInsert root bookmarkcreated bookmarks beneath a level 1 bookmark titled BY DOMAIN and will mimic the BY VISIT structure.If desired, select the and/or the check boxes to arrange the newly created bookmarksSort first level Sort second levelalpha-numerically. If these selections are not made, the bookmarks will be ordered as they appear in the BY VISIT structure. TheSort first level check box was selected in the example screenshot above, which sorted the newly created level 2 bookmarksalpha-numerically.Ensure the check box is cleared (not selected). This will prevent Swap Bookmarks from deleting theDelete existing bookmarksoriginal bookmark structure. If this check box is selected, the original BY VISIT bookmarks will be deleted.Click the button. The specified bookmark levels will swap places and will be grouped beneath a new level 1 bookmark titledStart"BY DOMAIN."

Expand and Shrink Bookmarks

Access

ToolBox > Bookmark Tools > Expand/Shrink Bookmarks

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Overview

Use this tool to expand or collapse all bookmarks in an open PDF document.

There is no dialog box associated with this tool. If the bookmarks are expanded in the open document, selecting this tool will collapse them. Ifthe bookmarks are collapsed in the open document, selecting this tool will expand them. If the open document has a combination ofexpanded and collapsed bookmarks, it may be hard to know which option will be applied. In these cases, just select Expand/Shrinkbookmarks repeatedly until the desired option is attained.

See to set a specific level to which the bookmarks will be expanded.ToolBox Preferences

Save the document to retain the result of this action.

Example of Expand/Shrink Bookmarks

Bookmark Attributer

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Overview

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Use this tool to modify bookmark properties in an open PDF document. The properties can be applied to all bookmarks in the document or toa selected bookmark level. In addition to the bookmark appearance and action, the bookmark case and sort order can be set. Setting eachproperty is optional, so only select the necessary check boxes. Settings in Bookmark Attributer can be saved as a Style for later use.

Bookmark Attributer Dialog Box

This tool can also be used in the mode so that bookmark properties can be made consistent across all selectedBatchdocuments.

Examples

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Select the radio button if all bookmarks need modification and if they all need to be consistent. This is the mostAll levelcommon selection. If only a specific level needs modification, however, select the radio button and thenSelect bookmark levelchoose the specific level from the drop-down list.Select the check box and set the bookmark and . (See the page for detailsBookmark appearance Color Style Common Featureson Bookmark Appearance.)Select the check box and set Bookmark Case. The options are: Title Case, lowercase, UPPERCASE, or SentenceBookmark casecase.Click the button to enter words that should not follow the selected Bookmark Case. (See the Exclude List details at theExclude Listbottom of this page.)Select the check box to set the Magnification and Open In options.(See the page for details on theseAction Common Featuresoptions.)If the bookmark level needs to be in ascending (A to Z) or descending (Z to A) order, select the check box, select theSort orderorder from the drop-down list, and then select the bookmark . Clear the check box to leave the bookmarksSort By Level Sort orderin the current order.To save these bookmark settings as a style for future use, enter the new style name (such as CDER) in the text field and clickStylethe button. The name will be added to the Style drop-down list. When these settings need to be used in the future, simply selectAddthe Style name from the drop-down list and the settings will be populated in the dialog box.Click the button. Bookmark Attributer will apply the specified bookmark settings to the specified bookmark levels.StartOnce the process is complete, click the button.Close

If edits are required for specific bookmarks, use the tool.Bookmark Editor

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Details

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Modify Button – When a Style is selected from the drop-down list, changes can be made to the populated settings and then appliedto the document. To save the changes made to the settings, click the Modify button.

Delete Button – When a Style is selected from the drop-down list, clicking the Delete button will remove the saved style fromBookmark Attributer.

The <Default> Style cannot be Deleted.

Exclude List… Button – This option is used to exclude certain words from the bookmark case setting when Bookmark Attributer isrun. For example, if Title Case is selected as the Bookmark Case and “FDA” appears in the bookmarks, add FDA to the exclude listso that it is not changed to “Fda” when Bookmark Attributer is run.

Bookmark Editor - Exclude List

An exclude list can be created and saved as an LST file. To create a list, enter a word in the Exclude List text field and click the Add button.The word will be added to the list box below. Add as many words as necessary. Click the Save or Save As button to save the file as an LSTfile. Name the file and save it in an appropriate location.

Once a file has been created and saved, it can be accessed and reused as needed by clicking on the … (ellipses) button. List entries can bemodified and new entries can be added as needed.

Words added to the Exclude List cannot contain spaces.

Selecting the check box will exclude a word from the bookmark case modification only if the case of that word matches theCase sensitivecase used in the Exclude List. For example, if a product named BrainO were added to the Exclude List and the check box isCase sensitivenot selected, then all instances of BrainO in the document would be excluded from the bookmark case setting when Bookmark Attributer isrun. However, if it is desirable to exclude BrainO only in the exact case form that appears in the Exclude list (and allow all other case forms,such as upper case BRAINO or title case Braino to be modified), then the check box should be selected.Case sensitive

Select the check box to exclude all words containing the added text. For example, if “ex” were added to the list and the “UseUse wildcardwildcard” check box was selected, then all words that contain “ex”, such as “exit” would be excluded from having the case altered.

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Bookmark Editor

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Adding Bookmarks to a Scanned Document From a Bookmark ListModifying BookmarksAdding New Bookmarks

DetailsPositionExpand and Collapse ButtonsAction

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Overview

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Use this tool to add, modify, and delete bookmarks in an open PDF document. The bookmarks from an open PDF document willautomatically be loaded into the Bookmark Editor dialog box when the tool is accessed. The dialog box is where individual bookmark namesand properties can be modified, destinations can be checked for accuracy (and corrected when needed), and new bookmarks can becreated and appropriately placed within the bookmark structure.

If the document does not contain bookmarks, a list of bookmarks can be created and Bookmark Editor can be used to add those bookmarksto any document that has the same or similar headings. Once loaded into the Bookmark Editor dialog box, the bookmarks can be modified asneeded. A scanned legacy study report is an example of a document where this may be an efficient method of adding bookmarks (sinceother, more automated tools such as Bookmark Generator cannot be used on scanned documents).

To QC bookmark destinations, double-click on the first bookmark in the Bookmark Editor list box, the destination page of that bookmark willdisplay. If it is correct, proceed to the next bookmark. If it is incorrect, navigate to the appropriate destination page using the browse buttons(arrows) located at the bottom of the Bookmark Editor dialog box. Once the correct page is displayed, reset the bookmark destination byselecting the Current Page radio button and clicking the Modify button.

Examples

Adding Bookmarks to a Scanned Document From a Bookmark List

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To add bookmarks to a scanned document it is necessary to either have an existing list of bookmarks saved as an LST file or to create thatlist. If a list needs to be created, it can be saved and then used for other documents.

With the scanned document and the Bookmark Editor tool open, click on the button (…) next to the field.Ellipsis List FileIn the Bookmark Titles dialog box, click on the button (…) next to the field to load the bookmark list file. Navigate to andEllipsis Fileselect the LST file. The path to that file will be populated in the File text field and the bookmarks saved in the file will be displayed inthe Bookmark Title List area.Click the button. OK

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Bookmark Titles Dialog Box

Bookmark titles can be added to the LST file by clicking on the button. An untitled bookmark placeholder willNewbe listed. Simply type in the actual bookmark title in the field. If new bookmarks were added to an existingUntitledlist of bookmarks, click the button to replace the existing LST file. Click the button to save theSave Save Asbookmarks as a new LST file.

Adding a New Bookmark to the List

Bookmarks from the uploaded LST tile will be populated in the drop-down list.Title

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Bookmark Editor Dialog Box Showing the Populated Title Drop-Down ListThe next step is to view each page of the document (using the Acrobat navigation arrows at the bottom of the window) anddetermining whether or not there is a heading on that page that requires a bookmark.If there is a heading on the page that needs bookmarking, click the drop-down arrow and select the appropriate bookmark titleTitlethat corresponds to the heading.

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Example of Page with Heading to be BookmarkedSelect as the .Goto View Internal Action TypeSelect as the .Current Page Destination PageClick the button to set the look of the bookmark. (See the page for details on BookmarkBookmark Properties... Common FeaturesAppearance.)Click the button. The bookmark will be added to the list area of the dialog box and to the bookmark pane for the document.Add

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Example of Bookmark Added to the List and to the Bookmark PaneContine through the document page by page to add all necessary bookmarks.

Modifying Bookmarks

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A bookmark’s title, destination, and/or properties can be modified with the Bookmark Editor tool.

Select an existing bookmark from the list box. All of the properties for the selected bookmark will be displayed in the Title, Action,and Destination Page group boxes.If the title of the bookmark needs to change, click in the field and enter in the corrected title.TitleIf the destination needs to change, click the drop-down arrow and select the appropriate action.Action TypeIf the needs to change select the appropriate action. To check the destination, double-click on the bookmark inDestination Pagethe Bookmark Editor dialog box. The document will jump to the bookmark's destination.If the , or needs to be changed, click the button. (See the pageStyle Color Magnification Bookmark Properties Common Featuresfor details on Action, DestinationPage, and Bookmark Properties.)Click the button. All of the modifications will be applied to the selected bookmark. Modify

Adding New Bookmarks

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Select an existing bookmark in the Bookmark Editor list box. This should be a bookmark that is either directly above or below wherethe bookmark should be added. (If the new bookmark should be indented (as a child), select the bookmark above where it should beadded.)Select the bookmark . (See the details below.) Position PositionSelect the destination from the drop-down list in the group box and select the .Type Action Destination PageClick the button, select the desired bookmark properties, and then click the button. Bookmark Properties OKClick the button. The new bookmark will be inserted into the existing bookmark structure.Add

Details

Position

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Position Options

The options in the Position group box provide the ability to add new bookmarks in the needed location in the structure and to create lowerlevel bookmarks (level 2, level 3, etc).

When adding a new bookmark, select an existing bookmark in the list that is either directly above or below the location intended for the newbookmark. Then, select the After radio button to place the added bookmark after the highlighted selection. Select the Before radio button toplace the added bookmark before the highlighted selection.

If it is intended to create a level 2 bookmark, select the existing bookmark in the list that will be the parent to this lower level bookmark. Then,select the Sub-section radio button to nest the added bookmark below and indented from the highlighted selection. This method can also beused to create lower level bookmarks (level 3, level 4).

When adding sub-sections it may be best to first add all of the level 1 bookmarks, and then go back and add level 2, thenlevel 3, etc. This is due to the fact that once a sub-section is created, it is not possible to add the next bookmark as a level1. If a sub-section is created and it is necessary to add higher level bookmarks, add them as the lower level, close theBookmark Editor dialog box, and then click-and-drag the bookmarks to their appropriate location in the bookmark pane.

Expand and Collapse Buttons

The Expand and Collapse buttons only affect the bookmark list within the Bookmark Editor dialog box. The bookmark pane will not beaffected. If it is necessary to expand or collapse the bookmarks in the bookmark pane, use the tool or the AcrobatExpand/Shrink Bookmarks bookmark pane Options.

Action

http://isiproducthelp.paper2pdf.com/display/TBX62/Expand+and+Shrink+Bookmarks

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Bookmark destinations typically are internal locations within the same document. Therefore, Goto View Internal will often be the selectionmade from the Type drop-down list. However, if another type is selected, (such as Goto View External or Open File), the File field and ellipsisbutton are enabled. Click the ellipsis (…) button to browse to and select the document that will be the bookmark’s destination. The path to theselected document will appear in the File field.

If Goto View External is selected, the Destination Page group box also will be enabled. (See the page for details on theCommon FeaturesDestination Page options.) If Open File is selected, the Destination Page options will not be available.

If Web Link is selected as the Type, the File field converts to a URL field. Type or copy and paste a URL into this field.

Bookmark Master and Bookmark Master Batch

Page Content:

AccessOverview

Bookmark By Using a KeywordBookmark By Selecting an AreaBookmark By Tabulation

ExamplesBookmark MasterBookmark Master Batch

DetailsArea Select ControlsCharacterFormatPrefixOpen BookmarkJump Page

Access

ToolBox > Bookmark Tools > Bookmark Master

Or

ToolBox > Bookmark Tools > Bookmark Master Batch

Or

Overview

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Bookmark Master is used to create up to three levels of bookmarks in text-based documents using a tabulation (a list of keywords orphrases), a keyword (and the content that follows the keyword), or an area of a page. This tool is to be used primarily on pharmaceuticalpatient data listings; however, it can be used on other document types, as well.

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Bookmark Master Dialog Box

Because regulatory electronic submissions typically contain many pharmaceutical patient data listing files that will need bookmarks, thesettings selected in Bookmark Master can be saved as an LST file, which then can be used in Bookmark Master Batch to create bookmarksin many documents simultaneously.

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Bookmark Master - Batch Dialog Box

A combination of the following options can be used to create the selected number of bookmark levels.

Bookmark By Using a Keyword

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The option works by entering a search word (or keyword) and specifying the number of words and lines following theBy using a Keywordkeyword that should be bookmarked. In other words, it is the content after the keyword, and not the keyword itself that actually will bebookmarked, it is the content after the keyword.

For example, if Bookmark Master is being used to create Patient Data Listing bookmarks and the various site numbers need to bebookmarked , “Site Number:” can be entered as the search word (or keyword) and then "1" could be entered as the number of words. Theresult would be that each time “Site Number:” is found during the search, the next text element would be bookmarked (creating bookmarkssuch as 01, 02, 03, etc.). A prefix can be added to make the bookmarks more descriptive.

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Bookmark Master, By Tabulation and Site Number Example in a Patient Data Listing File

Bookmark By Selecting an Area

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The option works by identifying a selected area of the page that contains the content to be bookmarked.By selecting an Area

For example, if the pages of a Patient Data Listing file contain one or more patient IDs that are located in a consistent area on each page,that area can be selected and the content within the selected area can be bookmarked.

The content within the selected area can be listed in one of the following ways:

List option - as individual bookmarks, one for each element found in the selected areaCompount option - as a series where the content from each page is listed as a single bookmark with each element separated by aselected value (such as a dash or a comma)From-To option - as a span where the content from each page is listed as a single bookmark and only the first and last value areincluded (separated by selected value)

A prefix can be added to make the bookmarks more descriptive.

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Example of Compound Subject Numbers and From-To Subject Number both with "Subject Number" as the Prefix

Bookmark By Tabulation

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The option uses a list of keywords (or keyword strings) to search for content to be bookmarked. Clicking on the By TabulationBy Tabulationbutton opens the Tabulation dialog box where a list can be created for each bookmark level. These lists can be saved, reused, and modifiedas needed.

Bookmark Master can be used only on text-based or OCR’d documents.

Once Bookmark Master is used, the settings will be maintained the next time the dialog box is opened. Settings can bereset or changed as needed.

Examples

Bookmark Master

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This example will demonstrate how to create bookmarks with two levels using the By Keyword and By Area options.

ToolBox > Bookmark Tools > Bookmark Master

Or

Select the radio button from the Number of Levels Used group box. Tabs for each level will be displayed.2 LevelsClick on the tab.Level 1Select the radio button and enter a keyword in the adjacent field, such as “Site Number:” in the adjacentBy using a Keywordfield. Note that it is important to enter the keyword(s) exactly as they appear in the document. The keyword in this example has acolon at the end.Click the button. The Bookmark Master - Prefix Level 1 dialog box will open.PrefixType the desired prefix (eg, Site) in the Prefix field. This specified text will appear before the bookmark titles. The entered keyword(s)

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can be used as the prefix by selecting the check box.Use Keyword as PrefixClick the button. The Bookmark Master - Prefix Level 1 dialog box will close and a check mark will appear on the Prefix button toOKidentify that a prefix will be used.If necessary click the button to remove a character or content from the end of the text that will be bookmarked.FormatClick the tab.Level 2Select the radio button and click the button. The Bookmark Master dialog box will temporarilyBy selecting an Area Select Areaclose and the cursor will change to the area selection tool.Draw a box around the area of the page that contains text to be bookmarked. Note that it is important to consider the content on allpages. So if a column of text is to be bookmarked, ensure that the box is drawn the full length of the column. The Bookmark Masterdialog box will reopen and the coordinates of the selected area will populate the fields.Select the desired (List, Compound, or From-To). See the details below for a description of each.Area Select ControlsIf needed select the types (Alpha, Numeric, and Punctuation) that will be recognized during the bookmarking process.CharacterIf the bookmarks should be displayed expanded once they are created, selected the and/or check boxes in theLevel 1 Level 2Open Bookmark area.Select the radio button in the Page Range group box.AllType a number (eg, 1) in the field. This will specify that no pages will be skipped during the bookmark creation process.Page JumpSelect the . Typically will be selected. (See the page for more details onMagnification Inherit Zoom Common FeaturesMagnification.)Click the button. This will open the Save List File dialog box. Navigate to a location to save the file and name the fileSave Config...appropriately. The saved settings will be available for future use in files when using Bookmark Master and Bookmark Master Batch.Click the button. The selected area will be searched for the specified keyword and text. A progress bar will appear andStarttrack the status of the process. Upon completion, the dialog box will close and the new bookmarks will appear in the Bookmarkspane.

Example of Bookmarks Created Using 2 Levels: By Keyword was used to bookmark Site Number (see top yellow highlighting) and By Areawas used to bookmark the Subject Numbers

Bookmark Master Batch

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This example demonstrates using the LST file that was save in the Bookmark Master example above to create bookmarks using the samesettings on multiple files.

ToolBox > Bookmark Tools > Bookmark Master Batch

Or

To use the saved LST file, click the button and browse to and select the file that contains the settings from BookmarkLoadMaster; click the button. The dialog box will close and the path to the LST file will appear in the Bookmark Information FileOpenfield.Click the button to add specific files. Click the button to add files within a folder. The Open dialog box willAdd Files Add Directorybe displayed. (See the page for more details on the Add Files and Add Directory buttons.)Common FeaturesBrowse to and select the desired files or directory of files to bookmark, and then click the button. The dialog box will close andOpenthe selected files will appear in the list box.

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To select multiple files within the same folder press and hold down the Ctrl key while making the selections. Toselect a span of files within the same folder, select the first file in the span, then hold down the Shift key and selectthe last file. All files between them will be selected.

If a directory of files is selected, individual files can be removed, if necessary.

Click the button. A progress message box will appear while bookmarks are created to each file in the batch list using theStartsettings in the LST file. Upon completion, the dialog box will close.

Details

Area Select Controls

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These controls specify how bookmarks will appear in the Bookmarks pane. This is applicable when using the optionBy selecting an Areafor creating bookmarks for subject numbers.

The option displays multiple bookmarks for a single page and lists them individually in the bookmark pane. (This is shown in the screenListshot examples above.)

The option provides one bookmark per document page, and will group the bookmarked items together in a string, separatingCompoundthem with the entered value (such as a hyphen or comma). Below is an example of the Subject Numbers bookmarked using the Compoundoption and a hyphen separating each value. The prefix is entered as a parent bookmark.

Example of Compound Subject Numbers with "Subject Number" as the Prefix

The option provides one bookmark per document page. Bookmarks for each page will include and a range of items separated byFrom-Tothe entered value (such as a hyphen or comma). Below is an example of the Subject Numbers bookmarked using the From-To option. Theprefix is entered once and then the first subject number on the page followed by the last subject number on the page.

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Example of From-To Subject Numbers with "Subject Number" as the Prefix

Character

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The options in this group box are used to select character types that will be recognized during the bookmarking process.

Alpha - Select this check box to recognize all alphabetical (A-Z) characters during the bookmarking process.Numeric - Select this check box to recognize all numerical (1,2,3,...) characters during the bookmarking process.Punctuation - Select this check box to recognize all punctuation marks (.,?,:) during the bookmarking process.

Format

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Format is used to customize a portion of the content that is captured for bookmarking. For example, select the Delete all content after __ check box and enter a character such as “:” to not include any characters that may come after the “:” when bookmarking thecharacter

content.

Additionally, the check box can be selected to remove the entered character from the bookmark.Also delete this character

The can be selected to specify a particular character that should be removed from the bookmarked content.Delete Last Character OptionSelect the check box and enter a character that should be deleted when it appears at the end of the bookmark text.

Bookmark Master - Format Level Dialog Box

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Prefix

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The content bookmarked during the search can be displayed with a Prefix in the Bookmark pane. When defining the Bookmark Mastersettings, click on the button. Type the desired prefix in the field, or, if "By Keyword" is the chosen method, selectPrefix User Defined Prefixthe check box to use the word(s) entered in the By Keyword field.Use Keyword as Prefix

Bookmark Master - Prefix Dialog Box

Open Bookmark

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If created bookmarks should be shown expanded in the bookmark pane, select the Level 1 and/or Level 2 check boxes. If these are notselected, the bookmark structure will be collapsed.

Since Level 1 bookmarks in the bookmark pane cannot be collapsed, these options actually refer to Levels 2 and 3,respectively. (eg, Select Level 1 to expand level 2 bookmarks.)

Jump Page

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During bookmarking, the number entered in this field will be the number of pages that are skipped over when searching for keywords and/ora selected page area.

iBookmark

Access

ToolBox > Bookmark Tools > iBookmark

Or

Overview

Use this tool to create bookmarks from selected text within a text-based or image-based PDF document. iBookmark uses Optical CharacterRecognition (OCR) when used on an image-based document.

There is no dialog box associated with this tool. When the tool is selected, the cursor will convert to the cross-hair selection tool (as shown inthe tool’s icon). Text is selected and a bookmark is created.

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iBookmark has many preference settings that allow for customized use. For example, when the “Keep iBookmark active until another tool isselected” option is chosen, bookmarks can be created continuously without having to select the tool each time. See the iBookmark

for details on all options.Preferences

Examples

Set the .iBookmark PreferencesWith a PDF document open, select the iBookmark tool. The cursor converts to the cross-hair selection tool.Use the mouse to draw a box around the text to be bookmarked. Once the mouse button is released, the text within the box willappear as a bookmark.

Each new bookmark will be added to the bottom of the bookmark list. The list can be reorganized by clicking anddragging the individual bookmarks around in the bookmark pane.

If the “Keep iBookmark active until another tool is selected” option is selected in the iBookmark Preferences, repeat step 3 to createadditional bookmarks.

With the proper options set in iBookmark Preferences, a bookmark structure with parent and child bookmarks canbe created. To create a child level bookmark (indented), hold the CTRL key while creating the bookmark. To createa parent level bookmark, hold the SHIFT key while creating the bookmark. To create a root-level bookmark, holdboth the CTRL and SHIFT keys while creating the bookmark.

Details

See the for details on all options.iBookmark Preferences

Hyperlink ToolsThe tools described in this section are the basic hyperlinking tools in ToolBox. Using the hyperlinking tools significantly reduces thetime-consuming and imprecise process of manually creating hyperlinks.


Text Quick LinkerCopy LinkInter-Document LinkerKeyword LinkerLink AttributerPage Linker


Text Quick Linker

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Creating an Internal HyperlinkCreating an External Hyperlink

DetailsOptions

Create multi-line linksClose this dialog box after setting linkKeep selection modeCreate a return linkShow a warning if the link path is absolute

Access

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ToolBox > Hyperlink Tools> Text Quick Linker

Or

Overview

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Use this tool to create individual hyperlinks in a PDF document by selecting text, setting a destination, and choosing the appropriate options.Destinations can be set within the same document (Goto View Internal), to another PDF document (Goto View External), to any other filetype (Open File), or to a web location (Web Link).

This tool can be used on both text-based and image-based documents.

Text Quick Linker Dialog Box

Examples

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Creating an Internal Hyperlink

With the appropriate PDF document open, access the tool.Text Quick LinkerIf working with a text-based document, click the button. If working with an image-based document, click the Select Text Select Areabutton. The cursor will change into the appropriate selection tool (text selection tool or area selection tool).In the PDF document, highlight (or draw a box around – for image-based documents) the text where the hyperlink should be placed.Select from the drop-down list. This will specify that the hyperlink’s destination will be to another pageGoto View Internal Typewithin the same document.Select the method to set the destination page. (See the page for details on the Destination Page options.)Common Features

If setting the destination with either the “Use page number” option (and the page number is unknown) or the"Current page" option, it is possible to scroll through the document to find the appropriate destination page.Alternatively, if bookmarks already have been created in the document, click on the appropriate bookmark todisplay the destination page. The original text selection location will be retained and will be displayed again oncethe hyperlink is created.

Click the button and select the appropriate settings from the and group boxes. (See the Properties Appearance Action Common page for details on the Properties dialog box.) Click the button.Features OK

Click the button and enter the distance from the text to the hyperlink border. This typically is set if the Line Type is set toMarginsVisible Rectangle in the hyperlink Properties. (See the page for details on the Margins dialog box.) Click the bCommon Features OKutton.If not already expanded, click the button to expand the area of the Text Quick Linker dialog box and select theArrow Optionsappropriate check boxes. (See below for details on each.)OptionsClick the button. A hyperlink will be created for the selected text to the specified destination page.Set Link

Creating an External Hyperlink

With the appropriate PDF document open, access the tool.Text Quick LinkerIf working with a text-based document, click the button. If working with an image-based document, click the Select Text Select Areabutton. The cursor will change into the appropriate selection tool (text selection tool or area selection tool).In the PDF document, highlight (or draw a box around – for image-based documents) the text to hyperlink.Select from the drop-down list. This will specify that the hyperlink’s destination is in another PDFGoto View External Typedocument. The field will be enabled.FileClick on the button adjacent to the field, and then navigate to and select the destination file.ellipsis (…) File

The file path will be displayed in the field. Although this displays as an absolute path, the hyperlinks that areFilecreated will be relative. This means that if the files are moved to another directory or storage area, the hyperlinkswill remain accurate (as long as the folder path structure does not change).

Select the method to set the destination page. (See the page for details on the Destination Page options.)Common Features

When setting the destination to an external document, the Current page option will be disabled.

Click the button and select the appropriate settings from the and group box. (See the Properties Appearance Action Commonpage for details on the Properties dialog box.) Click the button.Features OK

Click the button and enter the distance from the text to the hyperlink border. This is typically set when the "Line Type" is setMarginsto "Visible Rectangle" in the hyperlink "Properties." (See the page for details on the Margins dialog box.) Click theCommon Features

button.OKIf not already expanded, click the button to expand the area of the Text Quick Linker dialog box and select theArrow Optionsappropriate check boxes. (See below for details on each.)OptionsClick the button. A hyperlink will be created for the selected text to the specified destination document and page.Set Link

Details

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Options

Create multi-line links

At times hyperlink text may wrap around from one line in a paragraph to the next. In the example screenshots below, the text “Section9.3.2.1” was selected. In the first screenshot, the check box was selected and separate hyperlinks were created forCreate multi-line linkseach text line (both have the same destination) and only the selected text included in the hyperlink.

In the second screenshot, the links check box was cleared and one hyperlink was created and placed around all contentCreate multi-linewithin the lines.

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Hyperlinks created with the Create multi-line links option selected

Hyperlink created without the Create multi-line links option not selected

Close this dialog box after setting link

Select this check box to close the Text Quick Linker dialog box after the Set Link button is clicked and the hyperlink is created.

Keep selection mode

Select this check box to keep the Text Quick Linker dialog open and the cursor as a selection tool after the hyperlink is created.

Create a return link

This option allows for a hyperlink to be placed on the destination page that links back to the originating hyperlink’s page.

To create a return link, select this option and then click on the adjacent button.Setting

Text Quick Linker - Return Link Dialog Box

In the Text Quick Linker - Return Link dialog box enter the desired and in the corresponding text fields. This will be theWidth Heightdimensions (in inches) of the return link box. The box should be large enough to accommodate text that will be entered into the Note field.Select the border for the hyperlink box. Note that if no border is desired, select white as the border color.Color

In the text box, enter the text that will appear within the return link and then select the text , , and from the respectiveNote Font Size Colordrop-down boxes.

Click the button save the return hyperlink settings. OK

Show a warning if the link path is absolute

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Select this check box to generate a warning message that would indicate a relative link path cannot be created and an absolute path will becreated instead. The message will be displayed after the button is clicked. Click the button on the message to continue creatingSet Link OKthe link.

Text Quick Linker, Confirmation Message

Copy Link

Page Content:


Copying a Hyperlink

Access

ToolBox > Hyperlink Tools> Copy Link

Or

Overview

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Use this tool to copy an existing hyperlink in a PDF document and paste it to other pages within the same document. Each pasted hyperlinkwill be in the same page location as the original. Hyperlink destination and properties can be modified before pasting.

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Hyperlink Tools, Copy Link Dialog Box

Examples

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Copying a Hyperlink

Open a PDF document to the page where the link to be copied is found, and then access the tool. Hyperlinks on thatCopy Linkpage will be highlighted.

The Copy Link dialog box will not open until an area of the page is selected.

Using the cursor draw a rectangle around the hyperlink to be copied. The Copy Link dialog box will open.

Only one hyperlink can be copied.

Select the appropriate , , and for the hyperlink that will be pasted on the selected page(s). Even ifDestination Properties Marginthese items are the same as in the original hyperlink, it is best to check them to ensure the proper selections are chosen.Select the required . If is selected, the check box can also be selected so that the hyperlinkPage Range All Exclude current pagewill not be pasted to page it was copied.Click the button. The hyperlink will be pasted to each selected page in the same location as the original hyperlink. Start

Inter-Document Linker

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Page Content:


Creating Inter-Document HyperlinksDetails

Other Files

Access

ToolBox > Hyperlink Tools> Inter-Document Linker

Or

Overview

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This tool is used to create hyperlinks to external files or web pages using file paths and/or URLs. Either a selected area or the entire pagecan be searched for file paths and/or URLs, which, when found, will become the destinations for newly-created hyperlinks.

This tool is used in non-eCTD submissions (ie, eNDA, eBLA) to create hyperlinks from Case Report Form Tables of Contents to each casereport form document.


.

This tool can be used on text-based documents only.

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Inter-Document Linker Dialog Box

Examples

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Creating Inter-Document Hyperlinks

With the appropriate PDF document open, access the tool.Inter-Document LinkerSelect the and/or check box from the group box. If the check box is selected, the and Files URLs Destination Type Files Only pdf

check boxes will be enabled.Other filesSelect the check box to create hyperlinks to only PDF file paths. Select the check box to create hyperlinksOnly pdf Other filesto other file types. (See the section below for more information on selecting file types.) Both of these check boxes can beDetailsselected.If only a specific area of the page should be included in the search for file paths and URLs, then select the radioSelected areabutton. If the whole page should be included in the search, then select the radio button.Entire areaIf the radio button was selected, click the button. The Inter-Document Linker dialog box will temporarilySelected area Selectdisappear and the cursor will change into the area selection tool. Draw a box around the area of the page containing text to behyperlinked. The Inter-Document Linker dialog box will reappear and the coordinates for the selected area will populate the fields. Select the check box, when the link path contains"Do not include text where space from the path is greater than... inches"spaces. This check box allows for the space value to be entered.Select the check box, when the link path is multi-line. This check box"Allow multi-line paths when line distance is less... inches"allows for the space value to be entered.Set the hyperlink and . (See the page for details.)Margins Properties Common FeaturesSelect the . If the All radio button is selected then (or the ) on all pages in the PDF documentPage Range Selected area Entire areawill be searched for file paths or URLs. If only the displayed page should be searched, select the radio button. If onlyCurrent Pagespecific pages should be searched, select the radio button and then enter the specific page numbers or page range.PagesClick the button. Inter-Document Linker will search the PDF document and create hyperlinks for the files paths and/or URLsStartfound. The dialog box will close when the process is completed.

Details

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Other Files

Click the elipsis ( ) button adjacent to the check box, to modify the list of file types that will be included in the hyperlinking... Other Filesprocess. To include a new file type in the hyperlinking process, enter a file type extension in the text field at the top of the dialog box and clickthe button. To remove a file type from the hyperlinking process, select that file type from the list and click the button. Click the Add Delete Re

button to return the list to the default file types. The types shown in the screen shot below are the default file types.store

Inter-Document Linker - Check List Dialog Box

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Keyword Linker

Page Content:


Creating Hyperlinks by Entering a List of Keywords Creating, Saving, and Using an LST File to Select KeywordsSaving the Keyword List for ReuseUsing a Saved Keyword List

DetailsSelect Text Clear HistoryPage JustificationCreate links if source & destination pages are equalModifySelect AreaWildcard Characters

Access

ToolBox > Hyperlink Tools> Keyword Linker

Or

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Overview

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Use this tool to create multiple hyperlinks throughout a document from a list of keywords. Individual hyperlink destinations and properties areassigned to each keyword. The selected page range will be searched for the keywords and a hyperlink will be created for each foundinstance of the keyword. The list of keywords and all the associated settings can be saved and used to create hyperlinks in other documents.

Keyword Linker is typically used when adding hyperlinks to clinical and nonclinical summary documents that referencecontent in study reports.

This tool can be used on text-based or OCR'd documents only.


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Keyword Linker Dialog Box

Examples

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Creating Hyperlinks by Entering a List of Keywords

With the appropriate PDF document open, access the tool.Keyword LinkerType the desired keyword in the field.Keyword

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Select the check box to hyperlink the entered keyword only when it matches the case used in the Keyword field. IfCase sensitivethe keyword should be hyperlinked regardless of case, clear the check box.Case sensitiveSelect the link . (See the page for details.)Action Type Common FeaturesSelect the and . (See the page for details.)Link Properties Margins Common Features If the link “Action Type” is set to “Goto View External”, click the button, then navigate to and select the appropriateDestination Filefile.Select the and . (See the page for details.)Destination Page Page Justification Common FeaturesClick the button. The specified keyword will be added to the Keyword List box.AddRepeat steps 2 – 8 to add as many keywords as needed.Select the . This will be the selection of pages to be searched for the keywords in the list.Page RangeClick the button. The document will be search for the specified keywords and hyperlinks will be created for eachStartkeyword occurrence to their respective destinations. Upon completion, the number of hyperlinks created will be displayed in theKeyword List in the dialog box.

Creating, Saving, and Using an LST File to Select Keywords

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To quickly add keywords that are used in multiple documents, create, save, and reuse an LST file.

This option only creates a list of possible keywords that can be selected for use. It does not maintain property anddestination settings for each keyword. To save a keyword list with all of the settings, use the Save As option.

With the appropriate PDF document open, access the tool.Keyword LinkerClick on the ellipsis button ( ) next to the field in Keyword Linker dialog box. The Keyword Linker – Load List dialog box… List Filewill open.If a list file already exists, it can be loaded by clicking on the ellipsis button ( ) next to the field, navigating to the file, and… List Fileselecting it. The content of the LST file will be displayed in the Keyword List area. Changes or additions can be made to this list.In the Keyword Linker – Load List dialog box there are three options available to create a new keyword list or to make modificationsto an existing list. They are: , , and adding individual keywords manually.Import Bookmarks Import Named Destinations NewIf the document contains bookmarks or named destinations and these are strings of words that may need to be hyperlinked multipletimes in the document, click on either the or button. The Keyword List area will beImport Bookmarks Import Named Destinationspopulated with the bookmarks or named destinations.

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Keyword Linker - Load List Dialog Box

Individual keywords can be added to the list by clicking on the button. An untitled keyword placeholder will be listed. Type in theNewactual keyword title in the field.Untitled

It is possible to use a combination of these three options (Import Bookmarks, Import Named Destinations, andNew).

Keyword Linker - Load List Dialog Box, Adding a New Keyword

If this is a new keyword list, or if modifications made to an existing list are not intended to overwrite the existing list, click the Save

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button. To replace an existing list, click the button.As SaveClick the button. The Keyword Linker – Load List dialog box will close and the path to the saved LST file will be displayed in theOKList File field at the top of the Keyword Linker dialog box. Additionally, the Keyword drop-down list will be populated with thekeywords contained in the LST file.Click the drop-down list and select an appropriate keyword.KeywordSet the , , , and options. (See the page for details.)Action Type Properties Margins Destination Page Common Features Click the button. The keyword will be added to the Keyword List in the Keyword Linker dialog box. (This keyword now will beAddsearched for when the process runs.)Repeat steps 8 – 9 to add as many keywords as necessary.Select a and click the button. The document will be search for the specified keywords, and associated hyperlinksPage Range Startwill be created for each occurrence. Upon completion, the number of hyperlinks created will be displayed in the Keyword List in thedialog box.

Saving the Keyword List for Reuse

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Once a keyword list is created and all properties are set, it may be appropriate to save the list so that it can be reused for other documentsthat need the same or similar hyperlink navigation added.

After the keyword list is created, click the button. The Keyword Linker - Save Keyword List dialog box will open.Save AsNavigate to the location where the file should be saved and enter a name.FileSelect either (Excel) or (comma separated value) from the drop-down list.XLS CSV Save as typeClick the button. The keyword list will be saved as the specific file type.Save

Once a keyword list file has been saved, the button on the Keyword Linker dialog box will be enabled.Open

Using a Saved Keyword List

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With an appropriate document open, access the tool.Keyword LinkerClick on the button and navigate to and select the saved keyword XLS or CSV file. The save keywords will display in theOpenKeyword List area of the dialog box.If any modifications are needed to the , , , or for any of the saved keywords,Action Type Properties Margins Destination Pageselect the keyword from the list, make the changes, and then click the button. The list with the newly modified keyword canModifybe saved as an update to the currently saved list or the list can be saved as a new keyword list. (See the Save and Save As items inthe page.)Common Features If one or more of the listed keywords are not appropriate for this search instance, clear the checkbox next to the unnecessarykeywords in Keyword List. Alternately, one or more keyword lines can be selected and removed from the list by clicking the bDeleteutton. If keywords are deleted, the modified keyword listed can be saved to replace the currently saved list or saved as a newkeyword list. (See the Save and Save As items in the page.)Common Features Select a and click the button. The document will be search for the specified keywords, creating hyperlinks forPage Range Starteach occurrence of the keywords to their respective destinations. Upon completion, the number of hyperlinks created will bedisplayed in the Keyword List in the dialog box.

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Select Text

While the Keyword Linker dialog box is open, it is possible to still scroll through the open document to look for words that need to behyperlinked. Instead of manually typing the words into the Keyword field, click the Select Text button to highlight words; the selected wordswill appear in the Keyword field.

Clear History

Click the button to delete the entries in the drop-down list. This means that all keywords listed in the Registory EditorClear History Keyword(kHKEY CURRENT USER\Software\Image Solutiion.Inc.\Toolbox\keyword Linker\Keyword) will be deleted.

Page Justification

See the page.Common Features

Create links if source & destination pages are equal

Select this check box to create a hyperlink that points to a destination on the same page as the hyperlink source. For example, if the

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hyperlink is on page 12 and the destination is page 12, the hyperlink will still be created.

For pharmaceutical documents, is it recommended that this check box is cleared.

Modify

This button is enabled when the whole keyword line is selected (not just the check box) in the Keyword List. Click the Modify button to enablethe selected settings (Action Type, Properties, Margins, Destination Page Options, etc). Make any necessary changes to the keywordsettings. The Add button will then change into an Update button. Click the Update button to apply the changes.

Select Area

Select the adjacent check box to enable the Select Area button. Click this button to draw a rectangle around a selected area of the displayedPDF page to specify that only that area on each page of the page range is to be searched. If keywords are not within the selected area of thepage, they will not be hyperlinked. The selected location will be shown in either the portrait or landscape page images (depending on theorientation of the actually PDF page) located below the Select Area button.

Wildcard Characters

Keyword Linker supports two wildcards: “?” and “*”. Using a “?” means that one extra character will be allowed in the search (eg, if “Figure1.?” Is the keyword, then “Figure 1.1” would be hyperlinked, but not “Figure 1.11”).

Using an "*" means that multiple characters until the next space will be included in the search (eg, if “Figure 1.” is the keyword, then “Figure1.1” and “Figure 1.111” would both be hyperlinked.

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Link Attributer

Page Content:


Creating and Applying Hyperlink StylesUsing Link Attributer to Align the Borders of Hyperlinks

DetailsAlign Links Dialog Box

Align ButtonsSpace Evenly ButtonsMake Same Size ButtonsUndo Button

Link Attributer -- Edit Style Dialog BoxIgnore links that do not appear around text

Access

ToolBox > Hyperlink Tools> Link Attributer

Or

Overview


Use this tool to modify hyperlink properties in an open PDF document to ensure that they are consistent in appearance throughout thedocument. Once properties have been defined, they can be saved as a style and used in other PDF documents.

This tool can be used on text-based and image-based documents.

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Hperlink Tools,Link Attributer

Examples


Creating and Applying Hyperlink Styles

With an appropriate PDF document open, access the *Link Attributer* tool. The Link Attributer dialog box opens. <Default> isselected as the Style. Properties can be selected for the <Default> style or a new style can be defined and saved for future use.To select the style attributes, click the *Edit Style* button. The Link Attributer - Edit Style dialog box will display.

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Link Attributer - Edit Style Dialog BoxType a new style name (eg, FDA CBER) in the *Style* field.Set the *Appearance*, *Actions*, *Text Color*, and *Margins*. (See the page for details on these selections.)Common FeaturesClick the *Add* button. The new style with the selected attributes will be saved.

If an existing style is selected and changes are made to its settings, click the *Modify* button to save the changes.

Click the *Cancel* button. The Link Attributer - Edit Style dialog box will close. Alternatively, click on the *X* in the upper right cornerto close the dialog box. The new style will be added to the Style drop-down list. In the Link Attributer dialog box, select the newly saved style from the *Style* drop-down list.If it is necessary to view each hyperlink before attributes are changed, select the *Change One by One* radio button, and then clickthe *Find Next Link* button. The page that contains the next hyperlink will display and the hyperlink will be outlined with a greendotted line. If appropriate to change the attributes, click the *Change* button.If it is not necessary to view each hyperlink before changing the attributes, select the *Change by Page Range* radio button. Selectthe All, Current Page, or Pages option, and then click the *Change* button. A progress message box will appear while Link Attributerapplies the specified hyperlink attributes to hyperlinks found within the selected page range.

Using Link Attributer to Align the Borders of Hyperlinks

When there are multiple hyperlinks with visible borders on a page, it is important that they have a neat and even appearance (such ashyperlinks in a table of contents). The Align Links option can be used to create a neat and even appearance.

If the tool was used to create hyperlinks in a TOC, the Align Links option can be used to stretch thosePage Linkerhyperlinks across the full width of the text line.

With an appropriate PDF document open, access the *Link Attributer* tool and then click on the *Align Links* button. The LinkAttributer dialog box will close and the Align Links dialog box will open.

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Align Links Dialog BoxClick the *Select Links* button. The cursor will change into an area selection tool.Draw a rectangle around the area of the page containing the hyperlinks. One hyperlink border will turn red, which indicates it isanchor hyperlink. The anchor hyperlink is used to set the hyperlink size and position in which all other hyperlinks will be aligned. Anyhyperlink in the selected area can be assigned as the anchor hyperlink by simply clicking on it.To resize the anchor hyperlink, select the hyperlink and then drag a frame handle to the desired size and position.Click the *Left* button from the *Align* group box. (This is the first button in the Align group box.) All of the hyperlinks will be alignedto the left most link on the page.Click the *Vertical* button from the *Space Evenly* group box. The vertical space between each link will be even.Click the *Both* button from the *Make Same Size* group box. All hyperlinks will inherit the same width and height as the anchorhyperlink.

The *Undo* button can be used to remove any action applied to the hyperlinks in the selected area.

Repeat this process to align hyperlinks on other pages in the open PDF Document.When done, click the *Close* button. The Link Attributer dialog box will reopen.Click the *Close* button on the Link Attributer dialog box.

Details

Align Links Dialog Box

Align Buttons

Use these buttons to align hyperlinks in the selected area to the left, center, right, top, middle, and/or bottom in relation to the anchor link. Forinstance, if the “Left” option is selected, all links will be aligned to the left of the anchor hyperlink.

Space Evenly Buttons

Use these buttons to adjust the hyperlinks so they are evenly spaced horizontally or vertically in relation to the anchor hyperlink.

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Make Same Size Buttons

Use these buttons to adjust the width and/or height of hyperlink borders so they match the width and/or height of the anchor hyperlink.

Undo Button

Click this button to undo inappropriate adjustments made using the Align, Space Evenly, or Make Same Size options. This button can beclicked multiple times until all adjustments have been undone. If the dialog box is closed and then reopened, the Undo function will no longerbe available.

Link Attributer -- Edit Style Dialog Box

Ignore links that do not appear around text

Select this check box to exclude from modification hyperlinks that are around non-text based content, such as images or pages thatimage-based that contain hyperlinks.

Page Linker

Page Content:


Creating Hyperlinks Around a List of Page Numbers

Access

ToolBox > Hyperlink Tools> Page Linker

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Overview

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Use this tool to create hyperlinks for page numbers that are located within a selected area of a PDF page. The destination of each hyperlinkwill be the actual page number in the PDF document. For example, if number 29 is found during a scan of the selected page area, ahyperlink will be created with a destination of page 29 in the open PDF document. This tool is typically used to create hyperlinks for a table ofcontents, index, list of tables, list of figures, etc.

The technology used by Page Linker recognizes many numbering styles and formats, including:

Arabic Ordinal: 1, 2, 3, 4Chapter-Page: 5-17, 5-18, 5-19, 5-20Chapter.Page: 5.17, 5.18, 5.19, 5.20

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Chapter.Section-Page: 1.1-1, 1.1-2, 1.1-3, 1.1-4Uppercase Roman: I, II, III, IVLowercase Roman: i, ii, iii, ivAppendix-Page: A-1, A-2, A-3, A-4Appendix.Page: A.1, A.2, A.3, A.4Letter-Lowercase Roman: A-i, A-ii, A-iii, A-ivLetter-Uppercase Roman: A-I, A-II, A-III, A-IV

Page Linker even handles complex index pages that include multiple page references under a single same topic. The tool differentiatesbetween these adjacent page numbers, creating links around each page number within the selected area.

This tool can be used on text-based documents only.

Hyperlink Tools, Page Linker

Examples

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Creating Hyperlinks Around a List of Page Numbers

With the appropriate PDF document open, access the tool. The cursor will change to the Page Linker tool.Page LinkerDraw a rectangle around the area of the page that contains the page numbers that should be hyperlinked. The Page Linker dialogbox will display.

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Selected Page Area

It is not necessary to avoid characters other than pages numbers; these will not be recognized.

Set the , , and of the hyperlinks. (See the page for details.)Appearance Magnification Page Justification Common FeaturesClick the button. A hyperlink for each page number will be created with destinations to the specific page.OK

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Hyperlinks Created with Page Linker

See the tool for details on how to extend these hyperlinks (created with the Page Linker tool) acrossLink Attributer the page and align them with the left edge of the text.

Bookmark & Hyperlink ToolsThe tools described in this section incorporate functions that are run or used on both bookmarks and hyperlinks.


TOC Bookmarks & LinksExport & ImportDelete Bookmarks and LinksiDestinationBookmark & Link AuditorQC Viewer


TOC Bookmarks & Links

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Page Content:


Font InformationPage MappingPage OffsetOCR Properties

Access

ToolBox > Bookmark & Hyperlink Tools > TOC Bookmarks & Links

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Overview

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Use this tool to generate bookmarks from table of content (TOC) entries and/or to hyperlink those entries.

By selecting the page area where the TOC resides, the Bookmark & Hyperlink tool creates bookmarks for each TOC entry and sets thebookmark destinations to the corresponding page number listed in the TOC. This tool also is used to hyperlink TOC entries by much thesame method, if the TOC page numbers do not match the PDF page numbers, however, it will be necessary to enter a page offset.Additionally, if the document uses non-Arabic numbers (such as Roman numerals) it may also be necessary to use page mapping.

Often, the document TOC will span more than one page. Additionally, the first page of the TOC may vary from the rest by having a headingthat will cause the entries to start further down the page. The remainder of the TOC pages typically will start in the same location on eachpage. To compensate for this variation, TOC Bookmarks & Links provides the ability to select two different page areas. These selected areaswill be scanned to create the bookmarks and hyperlinks.

Font information, indent position, or sequence numbers can be used to create a multi-level bookmark structure that mimics the levels of theTOC. Font information can only be used when the TOC contains a unique combination of font name and size for each level, however. Inorder to use sequence numbers to create a multi-level bookmark structure, the TOC would need to contain section numbers (ie, 1, 2.1, 3.1.1,4.1.1.1). To use indent position, the format of the TOC entries would need to be indented for each level. If font variation, section numbers, orindentations are not used in the TOC, then the bookmark structure will be flat. In these cases a manual click-and-drag in the bookmark panecan be used to create a parent/child structure for the bookmarks.

This tool can be used on text-based or image-based documents that can be OCR'd using a function built within TOC builder.

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TOC Bookmarks & Links Dialog Box

Examples

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Select the area of the page where the TOC resides. For most documents this will be page 2 of the TOC. If the TOC is only one page,make the selection on that page.

Click the button. The dialog box will be temporarily hidden and the cursor will change into the areaSelect TOC Areaselection tool.Click and draw a box around the area of the page containing the TOC. The dialog box will be shown and the coordinates forthe selected area will be populated. This will specify the area to be used for all or most pages when TOC Bookmarks &Links searches for text to be bookmarked and hyperlinked.

When there are multiple TOC pages and the first page is aligned differently due to a heading, specify the search area for the firstpage.

Select the check box. This will enable the Select Area2 button and will specify that aDifferent area selection for first pagesecond selection area is needed for the first page of the TOC.

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Click the button. The dialog box will be temporarily hidden and the cursor will change into the areaFirst TOC Pageselection tool.On the first page of the TOC, click and draw a box around the area of the page containing the TOC. The dialog box will beshown and the coordinates for the selected area will be populated. This will specify the selection area to be used for the firstpage of the TOC when TOC Bookmarks & Links searches for text to be bookmarked and hyperlinked. (See the screenshotbelow which shows the area selection.)

Specify that hyperlinks should be created around each TOC entry.Select the check box.LinksClick the button. The TOC Bookmark & Link - Link Properties dialog box will open.Link PropertiesSelect the desired properties and then click the button. The dialog box will close.OK

The FDA requires that all submission files contain bookmark and hyperlink navigation of the TOC. TheCDER division of the FDA recommends that hyperlink appearance is a thin, visible rectangle with blacktext. The CBER division of the FDA requires that the hyperlink text color is blue and that the line type isinvisible. The text color can be changed with the tool.Link Attributer

Specify that a bookmark should be created from each TOC entry:Select the check box.BookmarksSelect the method to use to structure the bookmark levels.*- – this will use the section numbers (eg, 1, 1.1, 1.1.1, 1.2.1.1) found in the TOC to determineUse sequence numbersbookmark hierarchy. If there are some TOC entries that do not use sections (as seen in the screenshot below for the List ofIn-Text Tables and List of In-Text Figures entries), the entries without numbers will be handled as Level 1.- – this will use the position of indents for each line of the TOC to determine the bookmarkUse the position of indenthierarchy.- – this will use the font size and style to determine the bookmark hierarchy. ToUse font information to determine levelsuse this feature, select the radio button and then click the Font Information button to specify the attributes.Click the button. The Bookmark Properties dialog box will open.Bookmark PropertiesSelect the desired bookmark properties and then click the button. The dialog box will close.OK

If a document is imaged-based, select the OCR check box and click the OCR button to specify the settings. See the Detail sectionbelow for information on the .OCR PropertiersIf the document page numbering includes non-Arabic numbers (such as Roman numerals), it may be necessary to select the Use

check box. Page mapping defined using the stand-along Page Mapper tool can be usedpage mapping to identify page numbersor a new page map can be created within the TOC Bookmarks & Links dialog box. (See details below.)Page MappingIf the paper page numbers and the PDF page numbers don't match (eg, page '1' starts on the TOC, not the cover page), then aPage Offset may be needed. Type the appropriate offset (eg, 10) in the field. See the details below.Page OffsetSelect the radio button and type in the range of pages containing the TOC (eg, 5-12) in the field. This will specify thePages Pagespages to be searched to generate bookmarks and hyperlinks. If the TOC is one page only, select the radio button.Current PageClick the button. The dialog box will close and TOC bookmarks and hyperlinks will be created within the TOC in the document.Start

Example of Area Selection

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Example of Bookmarks and Hyperlinks Created using the Sequence Numbers to Create the Bookmark Structure

Details

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Font Information

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When using font information to structure bookmark levels, it is necessary to identify the fonts for each level (keep in mind the TOCmust contain a unique combination of font names and sizes for each level).

Once the radio button is selected, the "Font Information" button will be enabled. Click theUse font information to determine levels button to open the "TOC Bookmarks & Links - Font Information" dialog box.Font Information

Using Acrobat's Text Select Tool, select a line of text in the document that represents content that should be identified as a level 1bookmark and click the button in the TOC Bookmarks & Links - Font Information dialog box. The font name and sizeAdd Levelattributes for the selected text will be entered for Level 1. The result is that all text in the selected areas that use this particular fontname and size combination will be identified as a level 1 bookmark.Repeat step 2 as many times as necessary to select text that represent each bookmark level that should be created.Click the button in the TOC Bookmarks & Links - Font Information dialog box to save the font information. This information willOKremain in the dialog box and can be reused for other documents. If the font information is different in the next document, click the De

button and repeat step 2.lete All

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TOC Bookmarks & Links - Font Information Dialog Box

Page Mapping

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When document page numbering includes non-Arabic numbers (such as Roman numerals, which are unrecognizable to TOC Bookmarks &Links), page mapping can be used to associate these pages to PDF page count numbers.

The screenshot below illustrates a document that uses Roman numerals for the document’s introductory pages. Without page mapping,pages numbered with Roman numbers would not be recognized and destinations would be set as page 1. As a result, the remainder of thepages also would have incorrect destinations. However, if Page Mapping is used, the PDF page count numbers will be used to assignbookmark and hyperlink destinations for all pages.

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Example of Document with Roman Numerals

To use this feature, select the check box.Use page mapping to identify page numbers

Ignore numbers not following delimiters: If a line in a multi-line TOC text ending with a number, it could be mistaken for a pagenumber resulting in an incorrect link. This check box allows to avoid that situation by checking for the delimiter in fromt of the pagenumber candidates.Create a new page map: If page mapping was already done using the stand-alone tool, then this check box shouldPage Mapper be cleared and no other selections are necessary. If the stand-alone Page Mapper tool was not used, or if it is unsure whether ornot it was used, then select this check box.Lines to scan at top of page: Enter the number of lines that will be scanned at the top of the PDF page in this edit box. (Up to fourlines at the top of the page can be scanned to search for unrecognizable page numbers.)Lines to scan at bottom of page: Enter the number of lines that will be scanned at the bottom of the PDF page in this edit box. Upto four lines at the bottom of the page can be scanned to search for unrecognizable page numbers.

In the screenshot below, the bookmarks and hyperlinks have been created using TOC Bookmarks & Links, and the page mapping option wasused to associate the pages with the PDF page count. (See the highlighted PDF page count area.)

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Example of Bookmarks and Hyperlinks Create and Page Mapping Applied

Page Offset

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If the document page numbering and PDF page numbering do not match, then it is necessary to enter the appropriate page offset so thatbookmark and hyperlink destinations in the TOC go to the correct pages. This option typically is used when page numbering restarts after theintroductory pages.

For example, the screenshot below shows the document page number is 58 and the PDF page count is 68. To calculate the offset, use thefollowing formula: PDF page count # - document page # = page offset. In the screenshot below the page offset is 10.

Example of Page Offset

Another way to recognize that a page offset exists is that the page numbers in the TOC do not match the PDF page count.

Page mapping and page offset cannot be used simultaneously within the TOC Bookmarks & Links tool. If it is necessary toperform both functions, use the stand-alone tool and then TOC Bookmarks & Links with a Page Offset.Page Mapper

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OCR Properties

OCR: Optical Character Recognition (OCR) is used to capture content in image-based documents and covert them into editable text. Theoptions available enable the OCR result to have a higer accuracy rate depending on the need and the document quality.

TOC Bookmark & Link - OCR Properties

Antialias Graphics: If text within an image needs to be bookmarked and the image is in grayscale (not black/white), it may bebeneficial to select this option. The edges of the grayscale are smoothed out and the word(s) is captured more accurately. This hasno effect on the readability of graphics for the CCIT Group 4 TIFF images when copied.

Anti-aliasing is a technique of blending bitmap-based images and text to reduce the stair-stepping or jaggedappearance. In areas of transition, the edge pixels are blended to give a smoother appearance.

Antialias Text: If text is in grayscale (not black/white), it may be beneficial to select this option. The edges of the grayscale aresmoothed out and the word(s) is captured more accurately. This has no effect on the readability of graphics for the CCIT Group 4TIFF images when copied.Use color image if high accuracy is required: If the document was scanned using color, select this check box to recognize thecolor during the OCR process. This reduces the speed of the OCR process, however, the accuracy of the text will be much higher.Resolution: The resolution refers to the number of pixels per square inch. The higher number of pixels used, the smoother andsharper the image. The selection in this drop-down list determines the number of pixels recognized during the OCR process. Theavailable resolution choices are: 72, 100, 150, 200, 240, 300, and 400.

Additional Setup: Click this button to open the Tiger OCR Setup dialog box. The language is selected here along with the level to be usedwhen unrecognizable characters are encountered. The default settings are typically used.

The option should be selected if the document contains tables and the content within the tables needs to beTable OCRbookmarked.The option, when selected will remove carriage returns (CR) and line feed (LF) charactersRemove new line (CR/LF) characterwhen the selected area to bookmark spans over more than one line.

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Tiger OCR Setup Dialog Box

Export & Import

Page Content:


Exporting Bookmarks and Hyperlinks from a PDF DocumentImporting Bookmarks and Hyperlinks into a PDF Document

DetailsCRFTrack TOC FormatNotesExport OptionsImport OptionsExcel File Example

Access

ToolBox > Bookmark & Hyperlink Tools> Export/Import

Or

Overview

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Use this tool to export or import bookmarks, hyperlinks and their attributes to/from a CSV or an Excel file. Exporting bookmarks andhyperlinks broadens the options available to QC and modify bookmarks and hyperlink. By exporting bookmarks and hyperlinks to a CSV orExcel file, virtually every attribute of a bookmark and hyperlink can be easily modified. After the desired changes have been made, the filecan be saved and then imported into the document. Prior to importing, however, the original bookmarks and hyperlinks in the documentshould be deleted to prevent duplicates. See for details.Delete Bookmarks & Links

Exporting and saving the file can also be used as a method to backup bookmarks and hyperlinks in one or more documents.


Export / Import Dialog Box

Examples

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Exporting Bookmarks and Hyperlinks from a PDF Document

With the appropriate pdf document open, access the tool.Export/ImportSelect the radio button.ExportTo export both hyperlinks and bookmarks, select both the and check boxes.Links BookmarksClick the ellipses ( ) button adjacent to the File field. The Export Bookmarks and Links dialog box will open, where both the name...and saving location of the export file can be specified.Browse to the location where the CSV file should be saved, then type the desired file name in the File name field. Click the buttSaveon. The Export Bookmarks and Links dialog box will close and the specified path will appear in the field.If CSV were the selected file type, then the drop-down list would be enabled. Select the preferred value to separate theDelimiterentries. The options are Comma, Semicolon, Colon, Tab. The Delimiter drop-down list is disabled when Excel (*.xls) is the selectedfile type. See the details below.DelimiterSelect the . If the Links option was not selected, the Page Options will be disabled.Page OptionsClick the button. All bookmarks and hyperlinks in the document will be exported to the specified file type. A confirmationStartmessage will be displayed upon successful export of the bookmarks and hyperlinks.

Importing Bookmarks and Hyperlinks into a PDF Document

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Prior to importing, it is recommended to delete the original bookmarks and hyperlinks in the document to prevent duplicatebookmarks and hyperlinks. See the page for details.Delete Bookmarks & Links

With the appropriate pdf document open, access the tool.Export/ImportSelect the radio button.ImportTo import both hyperlinks and bookmarks, select both the and check boxes.Links BookmarksClick the ellipses ( ) button adjacent to the File field. The Import Bookmarks and Links dialog box will open....Browse to the location where the file containing the saved bookmarks and hyperlinks is. Select the file and click the button.OpenThe Import Bookmarks and Links dialog box will close and the path to the location will appear in the File field.If the page count of the document in which the bookmarks and hyperlinks are being imported to has changed (ie, a page wasadded), enter the number of pages in the field. See the details below.Offset OffsetIf the source Excel file is an export of multiple documents, select the option (links and bookmarks will beImport by “FILE NAME”mapped to the appropriate file. See the option details below.). If the source file is for one file, select the Import by FILE NAME Impo

radio button.rt all entriesSelect the check box.Check Link TextClick the button. All bookmarks and hyperlinks will be imported. A confirmation message will be displayed upon successfulStartimport of the bookmarks and hyperlinks. Click the button to close the confirmation message.OK

Details

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CRFTrack TOC Format

CRFTrack is a software application used for indexing batches of case report forms. Select this check box when the intention is to export thebookmarks from the open PDF document and import them into CRFTrack. This will format the bookmarks in the manner necessary forCRFTrack.

Notes

When neither the Links nor Bookmarks check boxes are selected in the Select Type group box, the Notes option becomes enabled. Selectthe Notes check box to export or import notes (comments) to or from the document. Notes can only be exported or imported as an Excel file.

Export Options

The options in this group box are enabled when the Export radio button is selected.

Delimiter - Select an option from this drop-down list box to set a delimiter type that separates the CSV file information. The availabledelimiter types are: Comma, Colon, Semi-Colon and Tab. Note that, the Delimiter drop-down list will be disabled if the Excel file(*.xls) option is selected in the Save as type drop-down list.Page Options - The options in this group box are enabled when the Export radio button and the Links or Notes check boxes areselected. Select the radio button to export hyperlinks or notes from all pages in the document. Select the option to exportAll Current pagehyperlinks or notes from only the displayed page. Select the radio button and then enter the page numbers to exportPageshyperlinks or notes from specific pages within the document.

Import Options

Offset - When importing into a document where the page numbering differs from the source document, enter a value into this fieldto compensate for the difference. For example, in a case where bookmarks and hyperlinks were exported from a document for QCpurposes and a signature page was added to the front of the document prior importing them back in, entering 1 as the Offset wouldcompensate for the added page and allow the bookmark and hyperlink destinations to remain accurate.

Remember, it is best to delete the existing bookmarks and hyperlinks prior to importing the QC’d ones back into the document. See the Deletpage for details.e Bookmarks & Links

Once importing is completed, it may be necessary to add a bookmark to the newly added page. See the page or Bookmark Editor iBookmarkpage for details on adding bookmarks.

Insert by “FILE NAME” - Select this radio button to import entries by first matching the file name. For example if bookmarks andhyperlinks were exported in batch mode, the associated file names will be included in the output. Those associated file names will beused to import the bookmarks and hyperlinks to the appropriate files.Check Link text - Select this check box to compare the text of the link to the text on the page prior to placing the link. If the exactlink text is found on the prior page, then the link will bot be imported into the file.

Excel File Example

This section explains the Excel file columns for exported bookmarks and hyperlinks.

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Example of Excel File Containing Exported Bookmarks and Hyperlinks

FILE NAME – This column displays the file name and path from where the bookmarks and links were exported.TYPE – This column displays whether the exported item is a bookmark or link.INDENT//SOURCE PG. # – This column displays the bookmark’s level number or the link’s source document page number.TITLE//TEXT – This column displays the bookmark or link name.ACTION – This column displays the action type for the bookmark or link.MAGNIFICATION – This column displays the magnification type for the bookmark's or link’s destination file.DEST. PG. # – This column displays the page number that the bookmark or link will open to in the destination file.DEST. FILE – This column displays the file name and path for the bookmark or link’s destination file.ZOOM – This column displays the percentage of magnification used when the magnification for a bookmark or link is set to fixed.DEST RECT L – This column displays the left coordinate for the link or bookmark rectangle in the destination file.DEST RECT R – This column displays the right coordinate for the link or bookmark rectangle in the destination file.DEST RECT B – This column displays the bottom coordinate for the link or bookmark rectangle in the destination file.DEST RECT T – This column displays the top coordinate for the link or bookmark rectangle in the destination file.LEFT – This column displays the left coordinate for the link or bookmark rectangle in the source file.RIGHT – This column displays the right coordinate for the link or bookmark rectangle in the source file.TOP – This column displays the top coordinate for the link or bookmark rectangle in the source file.BOTTOM – This column displays the bottom coordinate for the link or bookmark rectangle in the source file.COLOR – This column displays the selected color for the bookmark or link.STYLE/WIDTH – This column displays the bookmark’s text style or the link’s width.OPEN IN WINDOW – This column displays the setting for the window in which the destination file will open.OPEN/CLOSE – This column displays whether the bookmark is expanded (open) or shrunk (closed). N/A means that there is nolevel below the selected bookmark.NAMED DEST – This column displays the named destinations that the hyperlink is linked to.ABSOLUTE PATH – This column displays whether the action type for a link is an absolute path. If it is an absolute path, a “1” will bedisplayed, if it is a relative path a “0” will be displayed.FULL PATH – This column displays the absolute path.HIGHLIGHT STYLE – This column displays a link’s highlight style.LINE STYLE – This column displays the rectangle line style for a link.

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Delete Bookmarks and Links

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Deleting Bookmarks and Hyperlinks in a PDF Document

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ToolBox > Bookmark & Hyperlink Tools> Delete Bookmarks & Links

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Overview

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Use this tool to remove bookmarks and/or hyperlinks from PDF documents. Hyperlinks can be deleted on all pages, the current page, or onspecified pages. The tool also can be used to delete only broken bookmarks and/or hyperlinks.


Delete Bookmarks & Links Dialog Box

Examples

Deleting Bookmarks and Hyperlinks in a PDF Document

With the appropriate pdf document open, access the tool.Delete Bookmarks & LinksSelect the check box and then select the radio button. This will specify that all bookmarks,Bookmarks Delete all bookmarksregardless of whether they are working or are broken, will be removed. If it only is necessary to remove bookmarks with destinationsthat do not exist, select the radio button. If this option is selected, it also is possible to remove the childDelete broken bookmarksbookmarks of any broken bookmark by selecting the check box in addition to selecting the Include children Delete broken

radio button.bookmarksSelect the check box and then select the radio button. This will specify that all hyperlinks, regardless ofLinks Delete all linkswhether they are working or broken, will be deleted. If it only is necessary to remove links with destinations that do not exist, selectthe radio button.Delete broken linksIn the group box, select the radio button. This will specify that hyperlinks on all pages will be deleted. If links fromPage Range Allonly the displayed page should be removed, select the radio button. If links from only specific pages should beCurrent pageremoved, select the radio button and then enter the page numbers.Pages

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If the Links check box is not selected, the Page Range options will not be enabled (since bookmarks are notassociated with specific pages).

Click the button. A message communicating the number of bookmarks and links deleted will be displayed. Click on theDelete OKmessage.

In order to permanently remove the bookmarks and/or hyperlinks, the document needs to be saved. Therefore, ifbookmarks and/or hyperlinks are deleted mistakenly, close the PDF document without saving it.

iDestination

Page Content:


Creating Named Destinations from BookmarksCreating Individual Named DestinationsTo Use the Named Destinations

DetailsExport/ImportAdvanced OptionsMagnificationScan

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ToolBox > Bookmark & Hyperlink Tools> iDestination

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Overview

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Use this tool to generate named destinations, either directly from PDF document bookmarks or by manually entering the named destinationsinto the iDestination dialog box. Once named destinations are created, they can be used for setting hyperlink and bookmarkdestinations. Bookmark and hyperlink destinations typically are set to specific page numbers. However, while page numbers are an easy andaccurate way to set destinations, they also can be inflexible. By using named destinations, bookmarks and hyperlinks are set to targetspecific points of content rather than page numbers, ensuring that the links will not break if content is shifted to a previous or subsequentpage.


Technical Note: How do Named Destinations work? When a named destination is created, it is assigned the current pagenumber associated a specific point of content. This means that when a named destination is used to set ahyperllink destination, it is in essence linking to the assigned page number (and not to the content itself). However, if a pdfpage is added or deleted (moving destination content to a different page number), the page numbers associated withnamed destination are automatically updated and therefore, the hyperlinks will not break.

If the source Word document is changed and the PDF is recreated, the named destination process will need to be redone.

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iDestination Dialog Box

Examples

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Creating Named Destinations from Bookmarks

With the appropriate PDF document open, access the tool.iDestinationSelect the appropriate options in the and areas of the dialog box. (See the details of the and Advanced Magnification Advanced M

options below.)agnification DetailsClick the button. iDestination will generate named destinations from the document's bookmarks and listCreate From Bookmarkthem in the dialog box.Save the PDF document. This saves the named destinations with the document. These named destinations will then be availablewhen creating hyperlinks.

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iDestination Dialog Box with Destinations from Bookmarks Created

Creating Individual Named Destinations

With the appropriate PDF document open, access the tool.iDestinationClick the button. The word “Untitled” will appear in the list box along with the currently displayed PDF page number and theNewcurrent magnification.Double-click on the word in the column and enter a destination name. This will be the title of the named destination.Untitled Name

It may be helpful to create the named destinations while viewing the document’s table of contents.

Click on the number (in the Page column) and enter the appropriate destination page. When a hyperlink is created using thePagenamed destination, this will be the destination page.

It is possible to scroll or page through the document to identify the correct page number.

Select the appropriate fom the drop-down list. See the details below.Magnification MagnificationRepeat steps 3-5 to add each required named destination.Save the PDF document. This saves the named destinations with the document. These named destinations will then be availablewhen creating hyperlinks.

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To Use the Named Destinations

Once named destinations are created and saved with the PDF document, they will be available when using any of the bookmarking orhyperlinking tools. The example screenshots below show the "Text Quick Linker" dialog box with the "Name Destination" option selected.When the adjacent elipses ( ) button is clicked, the "Text Quick Linker - Named Destination" dialog box displays. This dialog box...contains the list of named destinations created and saved for that document.

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Text Quick Linker Dialog Box and the Named Destination Option

Details

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Export/Import

Use these buttons to save the named destination list as an Excel or CSV file. The saved file then can be imported into other PDF files thatshould use the same or similar named destinations. See the page for details on how to use these buttons.Common Features

Advanced Options

Remove sequence numberSequence number referes to the document section numbers that may be used in the bookmarks. Select this check box to removesection numbers from the named destinations. For example, if a bookmark title is “9.4 Treatments” and this option is selected, thenthe corresponding named destination will be “Treatments.” It may be best practice to use this option if section number changes areanticipated. If changes are not anticipated, it may be best to leave this checkbox cleared.Replace spaces with underscoresSelect this check box if spaces in the bookmark titles should be replaced with underscores in the named destinations. For example,if a bookmark title is “Primary Objective(s)” and this option is selected, then the corresponding named destination will be“Primary_Objective(s).” Note that although the named destination will be “Primary_Objectives(s)” (with the underscore), it will still linkaccurately to “Primary Objectives (s)” (without the underscore).Replace bookmark action by named destinationSelect this check box to override the bookmark’s magnification setting with the magnification setting selected in the iDestinationdialog box. The magnification can be selected in the “Magnification” group box or in the Magnification column’s drop-down list.

Magnification

Inherit magnification from current page viewSelect this radio button to open the destination file/page in the same magnification as the current view.Select MagnificationSelect this radio and an option from the drop-down list to open the destination file in the selected magnification. The availableoptions are: Fit Height, Fit Page, Fit View, Fit Visible, Fit Width, Fixed, and Inherit Zoom.Magnification Column Once named destinations have been created, click on the drop-down arrow in this column to display the magnification options.Select the appropriate option.

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Magnification Column Drop-Down Options

Inherit Zoom is required for regulatory documents.

Scan

If another PDF document is accessed while the iDestination dialog box is open (either by opening another file or by selecting a previouslyopened PDF document), the button will be enabled. Click the button to search the PDF document for named destinations. If theScan Scandocument contains named destinations, they will display in the iDestination list box.

Bookmark & Link Auditor

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Auditing Multiple FilesSelecting and Scanning FilesAudit

Checking and Modifying DestinationsUsing Go to Source, Go to Destination, and Edit ButtonsUsing the QC Viewer

DetailsBackslash ColumnJS Action ColumnSearch OptionsAction TypesAudit OptionsFind Bookmark Title and Link TextBookmark Spell CheckSave AuditDeleteMake Relative PathReportSet ColumnsContents CheckerQC Viewer

Item NumberSelect TypeCurrent Source FileTypeSource PageTitle/TextPrevNextCurrent ValidationQC bySet As Validation Buttons

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ToolBox > Bookmark & Hyperlink Tools > Bookmark & Link Auditor

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Overview

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The Bookmark & Link Auditor tool is used to perform two levels of QC on bookmarks and hyperlinks. The first is a high level check to confirmbookmark and hyperlink destinations exist (ie, search for broken hyperlinks and bookmark links). However, while this check verifiesthat destinations exist, it does not confirm destination accuracy.

The second QC level is a detailed check of each destination to ensure accuracy. This second level check can be performed directly withinthe Bookmark & Link Auditor dialog box; however, when checking more than just a few links, it is more efficient to perform this check usingthe QC Viewer. The QC Viewer tool is accessible from within the Bookmark & Link Auditor dialog box or as a stand-alone tool. Regardless ofthe access point, the dialog box options are the same.

Bookmark & Link Auditor also provides options to correct inaccurate destinations, modify properties, spell check, and delete bookmarks andhyperlinks. An audit report can be generated and saved as either a PDF or Excel file.

Bookmark & Link Auditor can be used on an open PDF document. However, to run the QC Viewer from either within Bookmark & LinkAuditor or as the stand-alone tool, all PDF documents need to be closed. The intention is to use QC Viewer on multiple documents.

While there are many options in the Bookmark & Link Auditor and QC Viewer dialog boxes, the basic QC process is as follows:

Files will be selected and then scanned to identify each bookmark and/or hyperlink within.An audit will be run on the bookmarks and hyperlinks. The audit will determine if the destination location exists, however it does notconfirm accuracy.Bookmark and hyperlink destinations are manually checked for accuracy, and a validation status is assigned to each.Run a report of the results.

TOC Bookmark & Link Auditor Dialog Box

Examples

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Auditing Multiple Files

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Selecting and Scanning Files

With no PDF files open, access the .Bookmark & Link AuditorTo include both bookmarks and hyperlinks in the audit, select the and check boxes from the Search OptionsLinks Bookmarksgroup box. To display the hyperlink text, select the check box as well. Once the scan is performed, the bookmarksInclude link textand/or hyperlinks will be listed in the Bookmark & Link Auditor dialog box. Hyperlinked text will be displayed in the Title/Text column.Select the radio button from the Action Types group box. This will specify that the document will be search forScan all action typesbookmarks and hyperlinks of all action types (ie, Goto View Internal, Goto View External, etc.).Click on the button.Batch FileTo add multiple files, click on the button. To add all files within a folder, click the button.Add Files Add DirectoryNavigate to and select the appropriate files or directory.

Files from multiple folders or multiple directories can be added by repeating steps 3 and 4.If a directory is selected, individual files can be removed.

Click the button. The files will be searched for bookmarks and/or hyperlinks. When completed the bookmarks and/or hyperlinksScanwill be listed in the dialog box.

See the page for details on the buttons within the Bookmark & Link Auditor – Batch Files dialogCommon Features box.

Proceed to the example below.Audit

Bookmark & Link Auditor - Batch Files

Audit

Select the radio button to check both the hyperlink paths and page numbers for existence. If only the pathsAudit path and page #are to be checked, select the radio button.Audit path onlyClick the button. Bookmark & Link Auditor will verify that the destination for each bookmark and hyperlink exists. The resultsAuditwill be displayed in the column of the list.Valid

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Auto Validated = The path and/or page number destination exists.Invalid = The path and/or page number destination does not exist.N/A = A destination has not been defined for the bookmark or hyperlink.

Checking and Modifying Destinations

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Bookmark & Link Auditor provides options to view the hyperlink sources and destinations. If only a few links are to be checked, it may beeasiest to use the and buttons within the Bookmark & Link Auditor dialog box. If many hyperlinks need toGo to Source Go to Destinationbe check, it typically is more efficient to use the QC Viewer.

Using Go to Source, Go to Destination, and Edit Buttons

This process should be performed on bookmarks and hyperlinks that reported an Auto Validated status from the Auto process.

Select a bookmark or hyperlink in the list.If the item selected is a hyperlink, click the button. The source document will open to the page where the link resides.Go to Source(Note that when a bookmark is selected, the Go to source button will be disabled since all bookmarks reside in the bookmark pane.)For either bookmarks or hyperlinks, click the button. The destination document will open to the page where theGo to Destinationbookmark or hyperlink destination resides. If the destination cannot be found an error message will be displayed.

It may be necessary to move the Bookmark & Link Auditor dialog box out of the way to see the source anddestination pages.

To apply an accurate bookmark or hyperlink destination, click the button.EditSelect the check box, select the appropriate Action Type, Destination Page, and if it is an external document, selectChange Actionthe Destination File. Click the button. The Valid column should now be blank for that item.OKWith that item still selected, right-click in the Valid column and select from the pop-up menu. The word Valid will beSet as Validentered into the column.Repeat steps 1--6 for each Bookmark and Hyperlink.

Using the QC Viewer

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QC Viewer will open only if all PDF documents are closed.

Click on the button. The QC Viewer dialog box will open and the files will be rescanned for bookmarks andLaunch QC Viewerhyperlinks. The right pane of the QC Viewer dialog box displays a document page with navigation and view options at the bottom. The left panecontains options to navigate to each link, view the Source and Destination, make modifications, and apply a validation status. (See"QC Viewer Dialog Box" screenshot below.)The first hyperlink in the documents will be selected.

Additional files or directories can be added to the QC Viewer using the and buttons.Add Files Add Directory

To review bookmarks and hyperlinks, ensure the radio button is selected as the option.Both Select TypeSince the source is already displayed in the right pane, click the button. The destination document will open inGo to Destinationthe right pane to the page where the bookmark or hyperlink destination resides. If the destination cannot be found an error messagewill be displayed.If the destination is inaccurate or cannot be found, select the appropriate and using the corresponding options inAction Destinationthe left pane. (See for details on these options.)Common Features

It may be necessary to review the document to identify the correct destinations.

If a change was made, click the button. The source page will be displayed in the right pane.UpdateClick the button (green check) to indicate that this hyperlink has been reviewed and is accurate. If the hyperlink could not beValidvalidated, select one of the other validation status options. The validation status selections will be added as metadata and displayedin the Bookmark & Link Auditor dialog box and in the report.Automatically, the source of the next hyperlink will display and be highlighted with a red outline.Repeat steps 3--6 to verify each destination.

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Click the button and reopen the Bookmark & Link Auditor tool.CloseRepeat steps 4--7 in the "Running an Audit on Multiple Files" example above to add the same batch of files. The Valid column willshow the Validation Status option that was selected for each bookmark and hyperlink. (See the "Bookmark & Link Auditor Dialog BoxShowing the QC Viewer Validation Status in the Valid Column" screenshot below.)Click the button. The Bookmark & Link Auditor – Report dialog box will open.ReportSelect the appropriate options (see the details below) and click the button. The report will be saved to the selectedReport OKlocation. (See the "Example Excel Report" screenshot below.)

QC Viewer Dialog Box

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Example Excel Report

Details

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Bookmark & Link Auditor Dialog Box

Backslash Column

This column is used to identify when a hyperlink or bookmark path contains a backslash. If the path does contain a backslash, the Backslashcolumn will display .Yes

JS Action Column

This column is used to identify when a file contains an external or open file hyperlink or bookmark. If the file does contain an external oropen file hyperlink or bookmark, the JS Action column will display .Yes

Search Options

Select options in this group box to indicate if the selected documents should be scanned for both bookmarks and hyperlinks or just one or theother. If Links is selected, an option is available to also include the link text in the scan results list.

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Action Types

When bookmarks and hyperlinks are created an Action Type is assigned. Select an option in this group box to indicate if all action types oronly specific action types should be listed once the documents are scanned. If is selected, the specific actionScan selected action typestype options (ie, Goto View Internal, etc.) will be enabled for selection. Select one or more specific action types.

When this option is selected, at least one of the action type check boxes must be selected for the scanning process to start.

If is selected, only destination paths that are using absolute paths (not relative paths) will be listed. If this optionOnly scan absolute pathsis selected, the Goto View External and Open File check boxes will be automatically selected and the Goto View Internal, Web link, andNone check boxes will be disabled. It is recommended that all hyperlinks have relative paths. This will ensure that if the file directory structurechanges, the link will not break.

Audit Options

Once the documents have been scanned, select an Audit Option. If the option is selected, then the audit will checkAudit path and page #that the path and page number exists. If is selected, then the page number will not be verified in the audit.Audit path only

Find Bookmark Title and Link Text

Once documents have been scanned, use this option to search for a specific bookmark or hyperlink in the results list. To use this feature,type the desired keyword into the text field, then click the button. The first bookmark or hyperlink using that keyword will be highlighted.FindClick the button again to go to the next bookmark or hyperlink using the specified keyword. The Title/Text column is searched for theFindkeyword.

Case sensitive - Select this check box to search only for words in the Title/Text column that match the case of each letter, as typedinto the text field.

Bookmark Spell Check

Click this button to open the Bookmark & Link Auditor - Bookmark Spell Check dialog box, which is used to check the spelling of bookmarktitles in the results list. Adobe Acrobat’s built-in dictionary is used for the spell check.

Bookmark & Link Auditor - Bookmark Spell Check Dialog Box

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Save Audit

Once an audit is run and changes are made to the validation status (either by using the right-click options or the Contents checker), click thisbutton to save the Validation Status selections. If the documents are scanned again, the saved audit information will be displayed.

Validation Status selections made using the QC Viewer will automatically be saved.

Delete

Click this button to delete selected bookmarks or hyperlinks from the PDF file. Once the button is clicked the documents will be rescanned.

This deletes the bookmark and/or hyperlink from the document, not just the list. This action cannot be undone!

Make Relative Path

Click this button to convert all absolute paths for bookmarks and hyperlinks in the documents to relative paths.

Report

Click the button to export information in the list box to a desired location. The report can be saved as either a PDF or Excel file. ToReportcreate a report for items filtered in the columns, select the radio button. To create a report from only specific columns,Only filtering resultsuse the Set Columns option to remove any columns not required in the report.

If more than one PDF file were scanned and audited, the report can be generated as a multi-sheet Excel file (one Excel sheet for eachdocument) by selecting from the drop-down list.Multiple sheet

Bookmark & Link Auditor - Report Dialog Box

Set Columns

Columns displayed in the list area of the Bookmark & Link Auditor dialog box can be modified. Click this button to open the Set Columnsdialog box, and select check boxes for the columns that should be displayed. Clear the check boxes for those columns that should not bedisplayed. (Columns set not to display will not be included in the generated report.)

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Bookmark & Link Auditor - Set Columns Dialog Box

Contents Checker

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The Contents Check is another way to verify the destinations of bookmarks and hyperlinks. Contents Checker is used to scan either thebookmarks or hyperlinks in an open PDF document. During the scan process the destination page will be searched for text that matches thesource text. The results of the scan will be listed in the dialog box. One of three results will be displayed for each bookmark or hyperlink:

If destination text exactly matching the source text is found, then the Result column will be empty.If a portion of the source text is found on the destination page, then the Result column will display “Partial source text found.”If the source text is not found on the destination page, then the Destination Text column will be empty and the Result column willdisplay “Not found.”

If the text exactly matches, select the line item in the list and click the button (green check) to indicate an accurate destination. If partialValidtext or no matching text is found, one of the other Validation Status buttons can be selected. Clicking on the validation status buttons willoverride the currently-displayed status for each hyperlink or bookmark in the Bookmark & Link Auditor dialog box list.

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Bookmark & Link Auditor - Content Checker Dialog Box

QC Viewer

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QC Viewer Dialog Box

Item Number

As a document is scanned, each bookmark and hyperlink found is assigned an item number according to the order in which they appear inthe document. The number in the Item Number field relates to the bookmark or hyperlink that is highlighted in the document and alsocorrelates to the Item number column in the Bookmark & Link Auditor dialog box. To go to a specific hyperlink or bookmark, type thecorresponding item number into the field, then click the button.Go

Select Type

Select the appropriate radio buttons to review bookmarks, hyperlinks, or both in the selected document(s).

Current Source File

This displays the name of the file containing the hyperlink or bookmark currently being validated. To validate bookmarks and hyperlinks in adifferent file, select the desired file from the drop-down list.

Type

This static text field indicates whether the item being validated is a hyperlink or bookmark.

Source Page

This static text field displays the page number where the hyperlink is located.

Title/Text

This field displays the bookmark or hyperlinked source text. If the item being validated is a bookmark, this field can be edited. If the itembeing validated is a hyperlink, the field will be static (non-editable).

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See the page for details on actions and properties.Common Features

Prev

Click this button to go to the previous item (either the previous bookmark or hyperlink). The previous bookmark or hyperlink will be selectedand its information will be displayed.

Next

Click this button to go to the next item (either the subsequent bookmark or hyperlink). The next bookmark or hyperlink will be selected and itsinformation will be displayed.

When reviewing each bookmark and hyperlink and setting a validation status, the next item will be automatically selectedonce the status is selected or the Update button is clicked. It will not be necessary to click the Next button.

Current Validation

This static text field displays the current validation status for the selected bookmark or hyperlink.

QC by

This field displays the login ID for the person logged into the computer or environment being used. This information will be saved with theaudit metadata. The name can be modified if needed.

Set As Validation Buttons

These buttons set the validation status for the bookmark or hyperlink as Valid, Invalid, Marked, or Not Validated for auditing purposes. If theAudit button is clicked, the item will be automatically audited to ensure a destination exists.Back to Top

QC Viewer

Access

ToolBox > Bookmark & Hyperlink Tools > QC Viewer

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The QC Viewer also is accessible from the Bookmark & Link Auditor dialog box.

ToolBox > Bookmark & Hyperlink Tools > Bookmark & Link Auditor

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Overview

The QC Viewer typically will be utilized in combination with the Bookmark & Link Auditor tool and can be accessed directly from inside theBookmark & Link Auditor dialog box. Regardless of the access point, however, the tool and functions are the same. Full details on the QCViewer are included on the page.Bookmark & Link Auditor

Image PDF Tools

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The tools described in this section are used to clean, enhance, and correct the appearance of documents and to block outimage-based specific elements within the document in both text-based and image-based documents.


iEnhanceiRedactMask


iEnhance

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Applying Multiple Functions SimultaneouslyModifying a Function

DetailsAdd

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Overview

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When documents have been scanned they are considered image-based PDF. However, there may be elements in a poorly scanneddocument that could be cleaned up to improve the quality. Use the iEnhance tool to run functions that correct specific image flaws. Functionscan be customized and new functions can be created.


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iEnhance Dialog Box

Functions listed in indicate that they can be used on documents scanned in color. When using the color functions, theredimage should cover a minimum of 70 percent of the page area. An error message will be displayed if the image does notcover the minimum page area.

Examples

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Applying Multiple Functions Simultaneously

Multiple functions can be applied simultaneously or they can be applied individually.

With an appropriate PDF document open, access the tool.iEnhanceSelect the appropriate functions from the column, and click the button to moveAvailable Functions right-facing double arrowthem to the column. (In this example the "De-Skew" and "Border Clean" functions will be selected and run onSelected Functionsthe example document page shown in the screenshot below.)Select the . Typically this will be , since each page of the document was individually scanned, the pagesPage Range Current Pagemostly likely will have individual issues.Click the button. The example below illustrates the result of the functions applied.Start

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A Before and After Example of Applying De-Skew and Border Clean Functions to a PDF Document Page

Modifying a Function

There are certain function parameters that can be modified to slightly change the effect. It is also possible to turn a function off, which allowsfor the function to still exist (rather than delete) yet have no effect on the document.

These functions should be cautiously modified.

Select a function from the column in the iEnhance dialog box, and then click on the button. TheSelected Functions Settingsettings dialog box for the selected function will be displayed.

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iEnhance Setting Dialog Boxes for Various FunctionsAs an example, the screenshots below show the orignial PDF page with markings along the side and bottom that need to becleaned. The iEnhance – Speck Remove function is applied to the original page (first screenshot below) at the default setting of 2 x 2pixels. The second screenshot shows the result of this. Some specks are removed, but not all. If the Speck Height and Width wereset to 10 x 10, all of the unwanted pixels would be removed; however, other markings that are within the 10 x 10 pixel range (suchas the lines between the table rows) would be removed, as well (as shown in the third screenshot).

It may be best to leave the default setting and to remove most of the specs and then utilize another function (suchas ) to clean up the remainder of the marks.iRedact

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Examples of Applying the Speck Remove function at the Default Setting of 2 x 2 Pixels and then at a Modified Setting of 10 x 10 Pixels

Details

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Add

Additional iEnhance functions built into ISIToolBox can be added to the iEnhance dialog box. See the iEnhance Image Functions Parameterspage for a list of available functions and descriptions of each.

To add a function, click the button in the iEnhance dialog box. Enter the name and .Add Function Parameter

Image Enhancement Parameters

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AccessOverviewImage Enhamcement Parameters

Access

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ToolBox > Image PDF Tools> iEnhance> Add

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Overview

The Image Enhancement Parameters listed in the table below are functions that can be added to the iEnhance dialog box. See the iEnhancepage for details on how to add one or more.

Image Enhamcement Parameters

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EnhancmentGroup

Name Keyword Description Value Example

De-Skew De-Skew SK Straightens the page image,automatically detects and corrects up to20% skew. All SK functions are set toon when SK is ON.

SK=ON

Max. AcceptableSkew

SK.MAS Maximum amount of skew acceptable.The larger the MAS value, the moreprecise the De-Skewing. The lower thepixel value, the higher the speed.

SK.MAS=250

Min. DetectLength

SK.MDL Minimum length of text or a line used todetect skew.

DefaultValue: 300pixels

SK.MDL=250

Shading De-Shade SH Removes dot shading and randomspecks from an image and increasesOCR readability. All SH functions areset to on when SH is ON.

SH=ON

Max. Speck Size SH.MSS Maximum width of individual speckscomprising shaded area to be removed.

SH.MSS=3

Horizontal SizeAdjust

SH.HSA Tweaks the horizontal component of theautomated speck sizing function. Set to1 if some specks survive; this willremove dots 1 pixel wider than itmeasured automatically.

SH.HSA=2

Character Protect SH.CP Protects characters from degradationwhile De-Shading. Set to 1 to protectthe horizontal plane, 2 to protect verticalplane, 3 to protect both planes and 0 todisable protection.

LimitedValue:0,1,2,3

SH.CP=3

Min. Area Height SH.MAH Smallest vertical height of an expectedshaded zone. Set lower to detectthinner shaded zones and higher toreduce false detects.

SH.MAH=100

Min. Area Width SH.MAW Smallest horizontal width of anexpected shaded zone. Set lower todetect narrower zones, set higher toreduce false detects.

SH.MAW=250

Vertical SizeAdjust

SH.VSA Tweaks the vertical component of theautomated speck sizing function, workssimilar to HSA.

SH.VSA=1

SpeckRemoval

Speck Remove SR Removes random pixelization, orspecks, from the scanned image.

SR=ON

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Horizontal SpeckRemove

SR.HSR Examines each horizontal scan line(single-pixel in height) and deletes agroup of black pixels whose length isless than the specified value. Settingthis value too high can removesegments of small text.

SR.HSR=2

Vertical SpeckRemove

SR.VSP Examines each vertical scan line(single-pixel in height) and deletes agroup of black pixels whose length isless than the specified value. Settingthis value too high can removesegments of small text.

SR.VSR=2

ImageAdjustment

Image Lighten Lightens an image by the specifiedcriteria. V3H3 will lighten an imagemore than V1H1. A high value canerode text.

OPTIONS=SF_DIALATE=V2H2

Image Darken Darkens an image by the specifiedcriteria. v3h3 will darken an image morethan v1h1. A high value can fill in textcharacters such as a,o,p, d, b, etc.

OPTIONS=SF_DIALATE=v2h2

Lines Horizontal/VerticalLine Management

HLM / VLM Detects and removes horizontal andvertical lines from an image. ReducesOCR errors. All VLM/HLM functions areset to on when VLM/HLM is ON.

DefaultValue:Off

LimitedValue:On; Off

VLM=ON HLM=PN

Edge CleaningFactor

VLM.ECF HLM.ECF

Cleans up noise near a line whenremoving it. This is useful for removing poor quality lines.Set to 3 or 4 if line remnants remain; 0or 1 if adjacent text is being degraded.

DefaultValue: 2 pixels

LimitedValue: 0-4pixels

VLM.ECF=0, HLM.ECF=3

Max. Line Group VLM.MLG HLM.MLG

Maximum allowed gap in a line. A valueof 2 or 3 allows removal of lines in poorquality images.

LimitedValue: 2,3-6*pixels

VLM.MLG=2, HLM.MLG=5

Max. LineThickness

VLM.MLT HLM.MLT

Maximum thickness of a line to bedetected.

VLM.MLT=5, HLM.MLT=30

Min. Line toDetect

VLM.MLD HLM.MLD

Minimum length of line to locate; canoptionally report and optionally remove.

VLM.MLD=200, HLM.MLD=100

ReconstructionWidth

VLM.RW HLM.RW

Determines maximum pixel width ofcharacters to be repaired after lineremoval. Set higher if text is not beingrepaired and lower if there is erroneousreconstruction. Set to 0 to disablereconstruction and lower the default inECF.

VLM.RW=0, HLM.RW=30

Registration Horizontal/VerticalRegister

HR/vR Positions text on page; providesconsistent left and upper margins fordocuments. All HR / VR functions areset to on when HR / VR is ON.

HR=On, VR=On

Central Focus HR.CF VR.CF

Determines Registration using only themiddle portion of the image border.Ignores letterheads, page numbers,logos, etc.

HR.CF=On, VR.CR=On

Add Only HR.AO VR.AO

Restricts program to adding margins.Ensures that no part of the image will be lost.

HR.AO=On, VR.AO=On

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Resultant Margin HR.RM VR.RM

Amount of left or upper margin that willremain in the document after correction.

HR.RM=200, VR.RM=175

Ignore Holes HR.IH Ignores binder holes and other left-edgemarks when analyzing the left margin.

DefaultValue:Off

LimitedValue:On; Off

HR.IH=On

Inverse TextCorrection

Inverse Type IT Detects inverse text (white-on-black)and converts it into normal text (black-on-white), alsohandles inverse zones of differentshapes. All IT functions are set to on when IT is ON.

IT=On

Min. Black onEdges

IT.MBE The horizontal distance between theedges of the inverse (black) zone and the inversetext itself. This is also the minimumhorizontal length of black pixels along the left and right edges of theinverse zone.

DefaultValue:10 pixels

IT.MBE=15

Min. Area Height IT.MAH The vertical height of the smallestexpected band of the inverse text. Decrease if smallinverse bands are being missed,increase if text is being treated as aninverse.

IT.MAH=60

Min. Area Width IT.MAW The minimum horizontal width of aninverse (black) zone. It will search for ahorizontal black line or area of at leastthis width.

DefaultValue:300pixels

IT.MAW=350

Cropping Crop Black CB Removes black borders from pages. CB=1

Crop White CW Removes white borders from pages. CW=1

Hole Remove SF_RMBLOB Removes holes, or a broken border.Typically used to remove three-holepunch marks.

CB=1, "OPTIONS= SF_RMBLOB=4000"

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iRedact

Page Content:


Page RangeRedact ButtonRemove last selectionUndoMultiple Redactions Simultaneously

Access

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ToolBox > Image PDF Tools> iRedact

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Overview

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Use this tool to permanently cover unwanted content within image or text-based PDF documents. A range of twenty colors are availableincluding black and white.

iRedact Dialog Box

The iRedact and Mask tools provide similar results. The difference is, the Mask tool will only cover up or hide text. Text thatis masked can still be included in search results. While the iRedact tool will permanently remove the content so that it willnot be included in search results.

Examples

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Access the tool.iRedactTo remove content in an image-based document or a specific area of a text-based document, choose the radio button.Select areaNext, select an option from the adjacent drop-down box. (Select to redact the content on the inside of the selected area.Inside areaSelect to redact all content that is outside of the selected area.)Outside areaTo remove specific text from a text-based document, choose the radio button.Select text

Multiple lines of text can be selected.

Select the check box. This will redact the selected area once OK is clicked on the iRedact messageAllow immediate redaction(see steps 5 & 6).

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Selecting this checkbox will disable the options.Page Range

If not already selected, to be used to replace the selected area.Select a colorClick the button. Depending on the selection made in step 2, select the desired content by either using the text selection toolSelector by using the area selection tool. An iRedact message will display communicating that the selected data will be permanentlyremoved and asking for confirmation that the process should continue. (See the Confirmation Message screenshot below.)

The button changes to a button.Select Stop

Click the button on the message to continue the redaction process. The selected text or area will be replaced by a block of theOKselected color. In this example, it will be cover by a black rectangle.Continue to select any additional content to be redacted (either on the same page or on another page). When finished, click the Stopbutton. The cursor will revert to the original tool.

Confirmation Message

Example of Text Redacted

Details

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Page Range

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When the check box is cleared, the Page Range options will be enabled. If or a specific range of isAllow immediate redaction All Pagesselected, the same area on each page will be redacted. However, if the selected area has no content, the redaction will not occur on thatpage.

An example of when it may be appropriate to select as the page range is when removing the header on all pages of the document.All

This setting will be remembered when the dialog box is closed and then reopened. Ensure that this setting is reviewed andset appropriately prior to redaction.

Redact Button

When the check box is cleared, the Redact button will become enabled as soon as text or an area has beenAllow immediate redactionselected. Click the Redact button to perform the redact process. The iRedact message will display to confirm the process.

Remove last selection

Click this button to unselect text or area selections made in error. Note that this only can be done prior to redaction.

Undo

Click the Undo button to remove the last redaction applied to the document. (This option is no longer be available once the iRedact dialogbox is closed, however.)

Multiple Redactions Simultaneously

It is possible to select multiple areas and/or multiple blocks of text (combinations of area and text). Once an area or block of text has beenselected, click the button. Then click the button again if selecting another area or additional text. Repeat as needed to selectStop Selectadditional content to redact. When redacting multiple selections of both area and text, select the appropriate radio button between makingselections.

Example of Mutliple Lines of Text Selected and a Selected Area for Simultaneous Redaction

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Mask

Page Content:


Masking and Hiding Text and Content Using the Show Option

DetailsSet Default MarginsUndo

Access

ToolBox > Image PDF Tools> Mask

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Overview

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This tool is used to mask or hide portions of a page. Mask can be used on both image-based and text-based documents, however, it isintended to be used on text-based documents. When used on a text-based document, text can be hidden and then restored at a later time.Additionally, when used on a text-based document, text can be hidden while graphics elements remain visible. When used on animage-based document, content cannot be brought back, therefore it is the same as using the tool.iRedact

Mask Dialog Box

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The and Mask tools provide similar results. The difference is that the Mask tool only covers up or hides content,iRedactand masked text can still be included in search results. Using Mask on image-based documents permanentlyiRedactremoves the content so that it can't be included in search results.

Mask can be used in mode.Batch

Examples

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Masking and Hiding Text and Content

Access the tool. The Mask dialog box will open and a blue margin box will be displayed on the page representing the area toMaskbe masked. The Margins area in the dialog box represents the placement of the blue box. (See dialog box screenshot above.)Use the cursor to resize the blue margin box until it outlines the page area where the content will be masked. The coordinates in theTop, Bottom, Left, and Right fields will update to reflect the resizing. (See example of area selected in the screenshot below.)

Coordinates can be entered manually into the Top, Bottom, Left, and Right margin fields.

Select the option if area that is to be masked also contains image content that should not be masked (such as,Apply only to textruling lines or logos) and/or if there may be a need to show this text in the future. If this is an image-based document, do not selectthe check box.Apply only to textIf the desired result is to have the content within the margin box masked, then choose from the drop-downInside Area Select arealist. If the desired result is to mask the content outside of the margin box, then choose from the drop-dowOutside Area Select arean box.Select the .Page RangeClick the button. A message will displayed both to confirm that this action should continue and as a reminder that theStartinformation will be hidden, not removed permanently. Click the button on the message to continue the masking process. (SeeOKthe example screenshot below of text hidden outside of the selected area.)

The dialog box remains open and the margin box remains on the page. This enables additional masking to bedone without having to access the tool again. Additional masking can be done on the same or another page. Tomask a different area, drag and resize the margin box as needed and repeat the process.

When finished masking, click the button.Close

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Examples of Area Selected and Outside Area Hidden

An example of when selecting the Outside Area and All pages options is beneficial is when both the header and the footerneed to be masked for the entire document. Ensure that the margin box is sized so that only the header and footer are onthe outside of the box. Then select Outside area and select All as the Page Range to mask the header and footer in theentire document at one time.

Using the Show Option

When text in a document has been hidden using the Mask tool, the text can be restored and a specific text color can be selected.

With a document that has had text hidden open, access the tool.MaskUse the cursor to adjust the blue margin box to select the area of the page where the text has been hidden.Select the check box and select the radio button. Apply only to text Show TextSelect either the or from the drop-down list as appropriate.Inside Area Outside Area Select areaClick the drop-down arrow and select the appropriate color for the text that will be shown. Color

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Selection Options to Show Hidden TextSelect the . Page RangeClick the button. All text within or outside the margin box will be restored in the selected color.Start

Example of Hidden Text Shown Using Blue

Details

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Set Default Margins

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The default margins are 1.00 inch for each coordinate (Top, Bottom, Left, Right). Click the button to use theseSet Default Marginscoordinates.

If the blue margin box is inadvertently lost on a page (dragged too far in a specific direction and can no longer be seen),click the Set Default Margins button to bring it back into view.

Undo

Click the button to remove the last masking applied to the document. However, this will option will no longer be available once theUndoMask dialog box is closed.

Copy ToolsThe tools described in this section simplify the process of copying text, tables, and graphics from both PDFs.text-based and image-based

The tools indluded in this section are:

ISICopyISICopy PagesISICopy Graphic


ISICopy

Page Content:


Copying and Pasting

Access

ToolBox > Copy Tools > ISICopy

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Overview

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The ISICopy tool works with both text-based and image-based PDFs. With text-based documents, the tool will simply copy the selected textto the clipboard to be pasted into another text editing application. With an image-based PDF, ISICopy performs on-the-fly Optical CharacterRecognition (OCR) to decipher the textual content of an image and copy it to the clipboard. The accuracy of the OCR is dependent on thequality of the scanned image, however. Poorly scanned or skewed pages will result in reduced accuracy. Use the tool to improveiEnhancedocument quality, which will then improve the accuracy of the OCR process.

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The default behavior of the ISICopy tool can be customized by setting preferences to make it work more efficiently for designated tasks. Seethe tool for details on all options.ISICopy Preferences

When this tool is selected, a dialog box will not open. Instead, the cursor will change to an area selection tool that is usedto select the area that will be copied to the clipboard.

Example

Copying and Pasting

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The copied information can be pasted into a text editing application such as Microsoft Word or Notepad.

Open the PDF document containing the text to be copied.Access the tool. The cursor will change to an area selection tool.ISICopyCreate a box around the area to be copied to the clipboard.

A clipboard is a software facility that temporarily stores data for transfer between applications.

Area Selected using the ISICopy ToolOpen a text editing application (eg, MS Word) and paste the copied information.

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Example of Copied Information Pasted into an MS Word Document

ISICopy Pages

Page Content:


Copying and Pasting PagesDetails

View after completeRemove line break

Access

ToolBox > Copy Tools > ISICopy Pages

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Overview

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Similar to the tool, this tool uses OCR technology to copy entire pages of text from both text-based and image-based PDFISICopydocuments to the clipboard, or to a text file.

ISICopy Pages Dialog Box

Example

Copying and Pasting Pages

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Open a PDF document with multiple pages.Access the tool to open the ISICopy Pages dialog box.ISICopy PagesTo copy the text to a clipboard, select the radio button.ClipboardTo save the copied text as a text file, select the radio button and then click on the adjacent ellipsis ( ) button to select aText file ...folder location where the file will be saved and to provide a file name.The next step is to define the page range. There are three options:

Select the radio button to copy text from the entire document.AllSelect the radio button to copy text from the current page only.Current pageSelect the radio button and enter a range (eg, 2 - 5, 8, 10) in the adjacent field to specify target pages. Text will bePagescopied only from those pages.

Click the button to begin the text copying process.StartOpen a text editing application (eg, MS Word) and paste the copied information.

Use the tool to copy images and paste them into the destination application.ISICopy Graphic

Details

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View after complete

Select this check box to automatically open the saved text file and view the copied data. This check box is only enabled when the Text fileradio button is selected.

Remove line break

Select this check box to remove any line breaks in the selected pages to allow for a continuous flow of text.

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If the desire is to paste the text and retain the orignial line breaks so that paragraph formatting is retained, do not select theRemove link break check box.

ISICopy Graphic

Page Content:


Copying and Pasting an Image

Access

ToolBox > Copy Tools > ISICopy Graphic

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Overview

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Use this tool to copy selected areas as an image from both text-based and image-based PDF documents. Because this tool copies contentdirectly from the file instead of the computer screen, the copied material will have a higher resolution.

For best results, the resolution of the copied image and the scanned image should match. The ISICopy Graphic tool resolution can be set inthe tool.ISICopy Preferences

The standard resolution used for scanning is 300 dpi.

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When this tool is selected, a dialog box does not open. The cursor changes to an area selection tool. Use the selection toolto select the area of content to be copied.

Example

Copying and Pasting an Image

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Open a PDF document containing the graphic to be copied.Access the tool. The cursor will change to an area selection tool.ISICopy GaphicCreate a box around the image (eg, figure, chart) that will be copied to the clipboard.

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4. Image Selected using the ISIGraphic ToolOpen the appropriate application (eg, MS Word or MS PowerPoint) and paste the copied information.

Copied Image Pasted in MS Word Document

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PDF ToolsThe tools described in this section are used to manage the PDF files.


Add and Remove Blank PagesBrowseFont ManagerGoto PlusHidden Text ManageriOptimizePage StamperPDF CorrectPDF OptionsSave PDF AsScale PDFSearch & Replace


Add and Remove Blank Pages

Page Content:


Deleting Blank Pages from a DocumentInserting a Blank Page into a Document

Access

ToolBox > PDF Tools> Add/Remove Pages

Or

Overview

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Use this tool to delete or insert one or more blank pages in a PDF document.Blank pages may appear in PDF documents as a result of the PDF rendition process. Elements within a Microsoft Word document that cancause blank pages during the PDF rendition process are manual page breaks, section breaks, and the default printer driver. TheAdd/Remove Pages tool will scan the entire document or a specified range of pages for blank pages and remove them.

Only pages that are completely blank will be removed when using this tool. (Pages that contain hidden text, although theymay visually seem blank, are not considered blank pages. Also, pages that contain minor content, such as a ruling line or alogo, are not considered blank.)

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Add/Remove Pages Dialog Box

Examples

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Deleting Blank Pages from a Document

Access the tool.Add/Remove PagesSelect the radio button (as shown in the screenshot above).Delete Blank PagesSelect the radio button to remove blank pages from the entire document. To remove blank pages only from a specified span ofAllpages, select the radio button and then enter a specific page range in the adjacent text fields.PagesClick the button.Start

Inserting a Blank Page into a Document

Access the tool.Add/Remove PagesSelect the radio button.Insert Blank PagesSelect the option to indicate where the blank page or pages should be inserted.

Select the radio button to place a blank page as the first page of the document.First PageSelect the radio button to insert a blank page as the last page of the document.Last PageSelect the radio button to insert one or more blank pages at specific locations within the document. (For example,Pagesenter page number 7 in the Pages field to specify that a blank page will be inserted at page 7 in the document. If additionalpages need to be inserted, enter the page numbers with commas between them, as shown in the dialog box example.)

Click the button. The blank page or pages will be inserted.Start

This process does not replace the specified pages with blank pages; this will add additional pages to thedocument.

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Browse

Page Content:


Access

ToolBox > PDF Tools> Browse

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Use this tool to view each page within a PDF document (in a similar fashion as a slide show). The amount of time that each page willbe displayed is set in the .ToolBox Preferences

There is no dialog box for this tool.

Examples

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If necessary, check or set the settings in the dialog box.Browse ToolBox Preferences Access the tool.Add/Remove PagesClick the mouse button or press any key on the keyboard to stop browsing. The page displayed when the mouse or a button ispressed will remain displayed.

Font Manager

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Access

ToolBox > PDF Tools> Font Manager

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Overview

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Use this tool to display a list of all fonts used in the open PDF document. The list will contain details such as Page Number (where the font isused), Type (ie, TrueType Font), Encoded standard, and whether or not it is an Embedded Font. The information in the list can be exportedas an Excel or CSV file format. Viewing this font information is beneficial when attempting to identify PDF files that may be problematic during the publishing process.

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Font Manager Dialog Box

It is recommended that all fonts used be embedded in the PDF document. This tool is used to ensure that all fonts areembedded so that the document can be viewed properly on all computers (such as the agency reviewers' computer), evenwhen fonts used in the document are not installed on the viewing computer. This tool cannot be used to embed the fonts: itis used only to report the information.

Examples

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Access the tool. Once this tool is accessed, the document will be scanned to find the fonts used and the informationFont Managerwill be displayed in the Font Manager dialog box.Select a font from the list to display the specific page in the document. All text using the selected font will be outlined in red, asshown in the example screenshot below.

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Example of a the Document Page with Selected Font Outlined in Red

If needing to view all instances where a specific font, type, encoding, or embedded status is used, filter the list. To filter the list, clickthe drop-down arrow in the column header and select the specific filter item. In the example screenshot below, the Font Namecolumn was filtered to only display the SymbolMT font.

Each filtering drop-down list will contain options appropriate for that column.

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Column Filter OptionsIf this is a font that should be changed it will typically be helpful to export the filtered font information (or non-filtered information) toan Excel or CSV file. To export the information, click the ellipsis (…) button and select a location to save the file. Select the file type(.xls or .csv), name the file and click the button. The selected path will display in the File text field.SaveSelect either the or radio button.All information Only filtering resultsClick the button. A confirmation message will display to indicate that the export was successful.Export

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Goto Plus

Page Content:


Calculating the Page Offset and Navigate to a Specific PageBrowsing the Document to Ensure QualityComparing Two Side-by-Side Documents

Access

ToolBox > PDF Tools> Goto Plus

Or

Overview

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This tool provides several options for viewing pages in open PDF documents. Including:

Go to a specific document page number or PDF page number (with the page offset automatically calculated)Standard navigation arrows to sequentially view each document pageBrowsing options to automatically display each page for a specified amount of timeComparing options to browse two documents side-by-side

Goto Plus Dialog Box

Examples

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Calculating the Page Offset and Navigate to a Specific Page

A page offset occurs when there are pages in the document (such as a cover page or other introductory pages) that do not use standardpage numbering, causing a mismatch of the PDF page number and the stamped page number (this is the page number generated by thesource software application, ie, Mircosoft Word). When using Goto Plus to navigate to specific pages, it is necessary to calculate the offset sothat accurate page numbers are accessed.

The screenshots below illustrate two page offset scenarios. The first screenshot shows a document that does not have a page offset (thestamped document page number matches to the PDF page number). The second screenshot shows a document with a page offset (thestamped document page number is 7 and the PDF page number is 9, creating an offset of 2).

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Example of a Document with No Page Offset

Example of a Document with a Page Offset of 2

Access the tool.Goto PlusNavigate to a page in the PDF document that has a stamped page number and enter that stamped page number into the text fieldnext to the button.Calculate OffsetClick the button. The entered page number will be subtracted from the PDF page number. The text field will reflectCalculate Offsetthe offset and the and fields will reflect the correct numbers.Paper # PDF #

The offset also can be entered manually. Subtract the stamped page number from the PDF page number andenter it into the text field next to the Calculate Offset button. Do not click the Calculate Offset button. The Paper #and PDF # fields will reflect the correct numbers.

Enter a specific or and click the button to navigate to that page.Page # PDF # Go

The Navigation Arrows (the four blue arrow buttons located below the Goto options) can be used to manually moveforward or backward one page at a time or to go to the first or last page of the document.

Calculating the offset is not necessary if the tool was used to define the offset. Simple select the Page Mapper Use the check box.page map

.

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Browsing the Document to Ensure Quality

The use of this function is similar to the tool; however, there are some additional options that allow a percentage of pages to view toBrowse be specified or allow a specific number of pages between each viewed page to be skipped. These options typically are used whenperforming an image quality assurance (QA) check of the document.

Access the tool.Goto PlusIf the Goto Plus dialog box is not expanded, click the down facing arrow (with the red plus sign). This will expand the dialog box andreveal additional options.Enter a in seconds. This is the length of time that each page will be displayed.DelayIn the field enter the number of pages to be viewed. (For example, if the document is 100 pages and only the first 25 pagesBrowseneed to be reviewed, enter the number 25 in this field. If all pages should be viewed, enter 100.)If the review is being performed for standard image quality assurance (QA) purposes, the check box typically will beOptions for QAselected. Then select either to view or a specific number of pages between each viewed page.Radom (%) Skip

If Options for QA is selected, the Browse field will be disabled since the Options for QA override the number ofpages to review option.

Select the . The options are: , or .Start Page Current Page First Page Last PageClick the right-facing double-arrow (at the bottom of the dialog box) to begin the browsing process. If Last Page was selected as theStart Page, use the left-facing double-arrow to begin the browsing process.

Comparing Two Side-by-Side Documents

This option can be useful when there is a need to compare more than one version of the same document in order to know which is theappropriate version.

With the two documents to be compared open, access the tool.Goto PlusSelect the check box.Support multiple PDF

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This check box will be disabled if the Options for QA check box is selected.

Select the appropriate documents comparison documents from the two drop-down lists located below the chSupport multiple PDFeck box.

The documents may automatically be selected if they are the only two documents open. These drop-down boxeswill list all open PDF documents.

Enter a in seconds. This is the length of time each set of pages will be displayed.DelayIn the field enter the number of pages to be compared. (For example, if both documents contain 100 pages and only the firstBrowse25 pages need to be compared, enter the number 25 in this field. If all pages should be compared, enter 100.)Select the . The options are: , or .Start Page Current Page First Page Last PageClick the right-facing double-arrow (at the bottom of the dialog box) to begin the comparison process. If Last Page was selected asthe Start Page, use the left-facing double-arrow to begin the comparing process.

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Hidden Text Manager

Page Content:


Removing Hidden TextModifying and/or Spell Checking Hidden Text

DetailsDelete Options

Access

ToolBox > PDF Tools> Hidden Text Manager

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Overview

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Hidden text can occur in a PDF document for various reasons. One reason is if the tool is used to hide text. Another reason is if theMaskAdobe Acrobat OCR (optical character recognition) function is used to create an invisible layer of searchable text.

When submitting documents to a regulatory agency or if file size is a concern it is recommended to remove hidden text.

Use this tool to delete hidden text from an image-based or text-based PDF document. Hidden text can be removed by page, by selectedarea, or by individual word. This tool also can be used to spell check hidden text.

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Hidden Text Manager Dialog Box

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Example of Hidden Text Highlighted Using the Text Selection Tool


Examples

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Removing Hidden Text

Access the tool.Hidden Text ManagerSelect the radio button. If the intention is to remove text regardless of where it is on the page, then select fromDelete Entire Areathe adjacent drop-down list. If hidden text should be removed from only a specific area, or if only specific words within the hidden textshould be removed, select the appropriate option from the drop-down list ( or , see the on theseSelect Area Word by Word Detailsoptions below).Select the from which the hidden text should be deleted.Page RangeClick the button. The hidden text will be removed.Delete

There is no message to confirm that the process should continue, and this process cannot be undone. If it is necessary tomaintain a copy of the document with the hidden text, save the document with a different file name or to a different location.

Modifying and/or Spell Checking Hidden Text

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Access the Manager tool.Hidden TextSelect the radio button and then select either or from the adjacent drop-down list. A search will beModify Current Page All Pagesperformed for hidden text (within the page or the document, depending on the selection in the drop-down list) and all strings ofhidden text found will be listed in the bottom portion of the dialog box.Select a string of text from the list. The location of that hidden text in the document will be outlined with a red box (as shown in theexample screenshot below).

If the selected string of text is from a page that is not currently displayed, the appropriate page will be displayed toshow the location of that text.

Example of a Specific String of Text Selected and the Location in the Document Outlined in RedIf it is necessary to edit this text, double click in the column and enter the replacement text. (It will be necessary to scroll the listEditto the right to be able to view the Edit column. Alternatively, resize the dialog box and/or the columns to view the Edit column.)

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5. Hidden Text Manager - Edit ColumnIf it is necessary to perform a spell check on the listed hidden text, click the button. The list of hidden text will beSpell Checkchecked for spelling errors and displayed in the Hidden Text Manager – Spell Check dialog box. Using the options in the HiddenText Manager – Spell Check dialog box, select to or each misspelling found. (A specific language dictionary can beIgnore Changeselected and proprietary names and other words can be added to the dictionary.)

Details

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Delete Options

There are three options to choose from when deleting hidden text:

Choose to remove hidden text that may be located anywhere within the area.Entire Area

Choose to remove hidden text from only a selected area. If is chosen, then the button is enabled.Select Area Select Area SelectClick the button and draw a box around the area of the page in where hidden text will be removed. The coordinates of theSelectselected area will be populated in the , , , and fields.Top Bottom Left Right

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Example of Word by Word Selected to Delete Hidden TextChoose to remove individual strings of hidden text. When Word by Word is selected the displayed page will beWord by Wordscanned for all hidden text. The bottom portion of the dialog box will convert to a list containing all hidden text found during the scan.

When a line of text is selected from the list, the location of that hidden text in the document will be outlined with a red box (as shown in theexample screenshot below). To remove the hidden text, click the button. By holding down the key multiple lines of text can beDelete Ctrlselected from the list in the dialog box and then deleted simultaneously.

Click the button to remove all of the hidden text on the page. Delete All

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Example of Word by Word Selected to Delete Hidden Text

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iOptimize

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Optimizing Files and Converting to Version 1.7Details

Refresh ButtonLogSetting RollupiOptimize - Setting Dialog BoxBasic mode Fonts & Images mode

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ToolBox > PDF Tools> iOptimize

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Overview

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Use this tool to convert a batch of PDF documents to a specified PDF version and optimize those files for fast web viewing. ICH (InternationalConference on Harmonization) guidance specifies that PDF version 1.4 - 1.7 should be used for all submission documents. Varying PDFversions may occur when documents originate from multiple sources.

Optimizing PDF files is a process of removing unnecessary elements from the file and performing certain tasks (such as,flattening layers and reducing resolution) to reduce the file size.

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iOptimize Dialog Box

This tool is designed to be used on multiple files, without having to run in mode.Batch

Examples

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Optimizing Files and Converting to Version 1.7

iOptimize is designed to be used on multiple files simultaneously. The documents are selected after the tool is accessed, so there is no needto open the PDFs documents prior to using the tool. However, it also is possible to access the tool if there are PDF documents already open(they will not affect the iOptimize process).

Access the tool.iOptimizeClick the elipsis ( ) button next to the field and then browse to and select the folder containing the files to be... Input Folderoptimized. The files within the folder will be listed in the iOptimized dialog box and will be scanned to determine PDF version andoptimization status. A message will display when multiple PDF versions are detected. Click the button on the message.OKSelect from the list the files to be optimized and converted to version 1.7. If the file list is long, it is okay to select all files and run theprocess. Files already optimized and in version 1.4 will not be affected.Click the button. The mode displaysBasic/Font Images/Navigation/Data & Object Basic/Font Images/Navigation/Data & Objectmany selections that can be made to modify the file (se the Details below). To optimize the files and convert them to version 1.7, it isnecessary to only select the and check boxes in the Basic mode. Ensure thatOptimize for fast wen view Convert to PDF version1.7 is selected from the Convert to PDF version drop-down list. Click the button. Note that selections made in each mode canSavebe saved as a style.Select the location. If the source files can be replaced by the optimized and versioned files, select the cOutput Folder Same Folderheck box. If there is a need to maintain the source files as is, click the ellipsis ( ) button and select a new folder location for the...optimized files.Click the button. Depending on the number of files and the options selected in each mode, this process may take a fewStart

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seconds to a few minutes. For example, if only optimizing and converting to version 1.7, the process should be quickly completed.

Details

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Refresh Button

Click this button to refresh the list of files. The files will be scanned again for optimization and PDF version.

Log

A log is a text-based file of the changes made to the files in the list box. To create a log file, click on the ... button and browse to a locationwhere the file should be saved. Once the iOptimize process is completed, click on the View Log button to open the file.

Setting Rollup

This section indicates the view of optimization profile settings in the main window.

Preview

Right-click on a selected file from the list and select to open a preview pane. Navigation arrows are provided at the bottom of thePreviewpreview pane so that each page of the selected document can be viewed.

Example of Viewing a Selected Document

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Example of Viewing a Selected Document

iOptimize - Setting Dialog Box

The selections made in this dialog box can be saved as a Style. Once a Style is saved is will be available in the Style drop-down list on themain iOptimize dialog box. Save and select a saved style to ensure the same settings are applied consistently.

Style - Enter a name in this field to create a new style.

Add - Click this button to save the new style.

Delete - Select a saved style from the drop-down list and click the button to remove it. The style also will be removed from the StyleDeletedrop-down list on the main iOptimize dialog box.

Export - See the Common Features page for details on this button.

Import - See the Common Features page for details on this button.

Basic mode

A log is a text based file that captures the changes made to the files in the list box. To create a log file, click on the button and browse to alocation where the file should be saved. Once the iOptomize process is completed, click on the View Log button to open the file.

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iOptimize Basic mode

- Select this checkbox to optimize the PDF for fast viewing on internet. If this checkbox is selected, Fast View isOptimize for fast web view

Yes be default in the Advanced section in Document Properties.

Convert to PDF Version - Select this checkbox to optimize the PDF version. This checkbox allows for a PDF version to be selected from thedrop-down menu.

Fonts & Images mode

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Fonts & Images mode

Unembed fonts (s) - Select this check box to remove fonts from the PDF document. Use this option with caution, however. If fonts are notembedded, substitute fonts may be used when the documents are opened on a computer without the necessary fonts installed, and thedocuments may not display or print as intended.

Embed fonts currently in use - Select this check box to ensure that all fonts used in the document are embeded. The ICH recommends theuse of embed fonts, and while it is recommeded to use only Times New Roman, Arial, and Courier in regulatory documents, there may betimes when other fonts are used, as well. Agenices cannot guarantee that any fonts other than the recommeded ones and fonts supported inAcrobat will be installed on their computers.

Convert color or grayscale image to monochrome - Select this check box to convert color or greyscale documents to monochrome. Thiswill reduce the file size. Monochrome documents are recommended for regulatory submissions.

Change the image - Select the check box and enter a DPI (dots per inch) to change the documents to a specificresolution to ...pixel/inchresolution (300 dpi is recommended for regulatory documents).

Navigate mode

IMAGE

Remove return hyperlinks - When hyperlinks are created using the Text Quick Linker tool an option to create a return link is provided. Ifthe return links are no longer needed, they can be removed by selecting this check box.

Discard all extermal cross references - Microsoft Word Cross References can be converted to PDF links. If they exist in the PDFdocument and are no longer needed, select this check box to remove them.

Remove links - Select his check box to remove hyper links from document.

Discard page map - When the Page Mapper tool is used to calculate page offsets, the information is saved with the document. Select thischeck box to delete the page mapping information.

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Discard page labels - When the Page Mapper tool is used to calculate page offsets, the mapped page numbers are embedded in thedocument as a label and the information is saved with the document. Select this check box to delete the page labels.

Discard removed page stamp history - When using the Page Stamper tool a history of added and removed stamps is maintained. Selectthis check box to remove the page stamp history.

Change the page rotation to zero - Select this check to set the rotation to zero.

Convert Backslash - When a link contains backslash, select this check box to convert from backslash to forward slash in a link.

Date & Object mode

IMAGE

Remove Comments - When PDF documents are reviewed, comments may be entered using the Adobe Acrobat Review tools. Select thischeck box to remove any comments that may be present in the documents.

Remove from submission, import and reset actions - If the Acrobat Form tools were used to add form elements (such as buttons, lists,and fillable text fields), select this option to remove the actions embedded within these elements.

Remove Javascript actions - Using the Acrobat Advanced JavaScript options, code can be added to set actions to occur within thedocument. If these actions are no longer needed in the document, select this check box to remove them.

Discard embedded thumbnails - Page thumbnails are created dynamicalli when the Page tab (from the Acrobat navigation pane) isaccessed. To prevent the time consuming task of creating thumbnails each time the Page tab is opened, they can be embedded in thedocument by selecting Option > Embed All Page Thumbnails. While embedded thumbnails speed up the document viewing process, theyalso make the file larger. If thumbnails have been embedded, select this check box to remove all embedded thumbnails.

Remove section marks - When using Split PDF or Merge PDF there are options to create sections. If those sections still exist in thedocument they can be removed by selecting this check box.

Discard embedded documents - There are various tools in Acrobat to embed a file (example: Attach File as Comment, Movie 3D Tool).Having embedded files will increase the file size. Select this check box to remove all embedded files.

Removehidden layer content and flatten layers - Layers may have been added to a PDF document during various processed, such asoptical character recognition, using the ToolBox Mask tool (creates hidden layers), or Page Stamper (creates visible layers). Select thischeck box to remove hidden layers and flatten visible layers. The document will look the same, but will not contain the layer information.

Remove PDF document tags - Select this check box to remove PDF tags. After the PDF tags are removed, right-click on the opened PDFfile, the Tagged PDF information displays No in the Document Properties dialog box.

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Page Stamper

Page Content:


Adding Content in the Header or FooterApplying a StampRemoving a Stamp or Header/Footer

DetailsPage Stamper Dialog Box

AlignmentRotationContinuous Page Numbering for Batch Check Box

Page Stamper - Header / Footer Dialog BoxCreate Link check box and buttonSave Left/Center/Right TextCommon

Apply Starting Chapter NumberApply Starting Page NumberPad with ___

Number of Digits

Access

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ToolBox > PDF Tools> Page Stamper

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Overview

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Use this tool to stamp text-based content into the header or footer of a PDF document. This tool also can be used to stamp a watermark intothe document or to superimpose content (such as a confidentiality statement) onto the document.

Page Stamper Dialog Box

This tool can be used in the mode.Batch

Examples

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Adding Content in the Header or Footer

Content can be stamped into both the header and footer in the document. The process is the same for both.

Access the tool.Page StamperSelect the and/or check box.Apply Header Apply FooterIf the Apply Header check box is selected, click the button. If the Apply Footer check box is selected, click the Edit Header Edit

button.FooterThe options are the same for both the Page Stamper – Header and Page Stamper – Footer dialog boxes. Therefore, the remainingprocess steps are applicable to either.

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Page Stamper - Header / Footer Dialog BoxThe top portion of the dialog box provides text boxes for the , , and areas of the header/footer. Click within one ofLeft Center Rightthese areas to begin adding content.There are two ways to add content. One way is to simply type the desired content into the Left, Center, and/or Right fields. The otherway is by choosing from among the preformatted variables from the area of the dialog box. Select a category fromCategory Typethe drop-down list. The Type options are:

DateTimePage NumberChapter NumberFile NameDocument InformationDocument Create DateDocument Modify Date

Depending upon the option chosen, the drop-down list will be populated with the appropriate selections. (For example ifFormatDocument Information is selected as the Category, the options in the Format drop-down list will be: Author, Subject, Title, Creator,Producer, and Trapped.)

If Document Information and a Format option are selected, the content is pulled from the Acrobat DocumentProperties. Click on File > Document Properties in Adobe Acrobat to see this information. Author, Subject, Title,Creator, and Producer are found on the Description tab. Trapped is found on the Advanced tab.)

Select the appropriate Format. Note that when items like time or date are selected, the time or date when the stamp was applied willbe entered.Once a Category Type and Format are selected, click the button. The selections will be placed in the Right, Center, or LeftInsertfield, depending on selection made in step 4.Repeat steps 4 – 6.to enter text in each field (Left, Center, Right) as necessary.Click on the button to set the desired , , and . (See the page for details on Font Properties.)Font Font Size Color Common Features Click the button. An Offset is the margin that will be used when stamping the header and footer content on the page. IfOffsetapplying a header, the Bottom margin will be disabled since it is not needed. If applying a footer, the Top margin will be disabled.Enter the margin (in inches) in each necessary field and then click the button on the Offset dialog box. OK

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Offset Dialog BoxClick the button on the Page Stamper - Header/Footer dialog box.OK

See the below for more information on the Options and Common (Header & Footer) areas of the dialogDetailsbox.

On the Page Stamper main dialog box select the desired and . (See below for on these options.)Alignment Rotation DetailsSelect the . (See the page for details on Page Range.)Page Range Common Features Click the Button. The selected header and/or footer information will be stamped on the selected pages in the document.Start

Applying a Stamp

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There two options for choosing the content to be stamped: pre-defined stamps and stamping content from another file. While there arenumerous pre-defined stamps, the most commonly applied are Approved, Draft, and Confidential. Content from another file is copied andstamped in the open document in the same location where it existed in the source document. Typical uses for this option include stampingheader information, logos, or confidentiality statements.

Access the tool.Page StamperSelect the check box.Apply StampClick the button.Edit StampIf using a pre-defined stamp, select the radio button. Choose the appropriate options from the , , From Stamp Category Name Opaci

, , and drop-down lists, and then select the appropriate radio button. Click the button.ty Vertical Horizontal Size OKIf using content from another document, select the check box. Then, click the or button toFrom File Add Files Add Directoryselect the file (or files) containing the content for the stamp. (Multiple file example: there may be two source documents selected,one containing content that should be placed in the header and one containing content that should be placed in the footer.) Once thedocument is selected, select either the or radio button. As indicated in the dialog box, stamped contentSuperimpose Watermarkthat is superimposed will be layered above the existing content. Content that is stamped as a watermark will be layered belowthe existing page content. Click the button on the Page Stamper - Edit Stamp dialog box.OK

Page Stamper - Edit Stamp Dialog Box

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On the Page Stamper main dialog box select the and . (See below for on these options.)Alignment Rotation DetailsSelect the . (See the page for details on Page Range.)Page Range Common Features Click the Button. The content will be stamped on the selected pages in the document.Start

Removing a Stamp or Header/Footer

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Stamping history information is retained so that it can be modified or removed.

With a document open that contains stamps, access the tool.Page StamperClick on the button.ModifyIn the Page Stamper – Modify / Remove History dialog box, select the check boxAlso show history for the removed itemsto reveal all Page Stamper actions performed on the open document. As shown in the screenshot below, previously removed pagestamps are listed with the corresponding information. The stamp history can be removed using .iOptimize

Page Stamper - Modify / Remove History Dialog BoxTo remove a stamp, select the corresponding line in the Page Stamper - Modify / Remove History dialog box. The area of the pagewhere the stamp was applied will be outlined with a green dotted line. This is helpful to ensure that the correct line is selected in thedialog box.If a link was created for the stamp, select either from the area of the dialog box. If no link was applied,Hyperlink Removal Typeselect the radio button.Stamp/Text

Only the available options will be enabled. For example, if a link was not created the Both and Only Link optionswould not be enabled.

Click the button. A confirmation message will be displayed to confirm the action. Click the button on the message. Remove Yes

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Only the predefined variables can be modified (for example, the modify function can be used to change a date stampformat). Select the stamp action that needs to be modified and then click the button. The applicable Edit dialog boxModifywill be displayed. New text can be entered, or a new and can be selected.Category Format

Page Stamper - Edit Header/Footer Dialog Box

Details

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Page Stamper Dialog Box

Page Stamper Dialog Box, Alignment and Rotation Options

Alignment

Print – Select this option to apply header/footer or stamp content in the position reflecting the printed page. For example if the page ischanged to landscape, select this radio button to ensure that the stamps are placed in the landscape orientation on the printed page.

Screen – Select this option to apply header/footer or stamp content in a position that reflects how the page orientation is intended to beviewed on the screen.

Short Edge – Select this option to apply header/footer or stamp content on the short edge of the page regardless of the orientation (portraitor landscape).

Depending on the viewing rotation of the page, the stamp may be located on the opposite short edge then what wasexpected.

Rotation

For image-based PDFs (paper documents scanned to create a PDF), a rotation may have been set as a tag in the document metadata. Thisrotation information can be viewed when is run on the document or set of documents. To ensure the stamp is placed in thePDF Informationintended location, it may be best to check the rotation and then select the matching rotation in this area of the Page Stamper dialog box.

Continuous Page Numbering for Batch Check Box

When using Page Stamper in mode and stamping page numbers on multiple documents, select this check box to continuously numberBatch pages from document to document. The numbering of the documents will be in the order in which they appear in the Batch dialog box. Thereare arrows in the Batch dialog box to reorder the list of files.

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Page Stamper – Header / Footer Dialog Box

Page Stamper - Header / Footer Dialog Box

Create Link check box and button

Select this check box to create a hyperlink around the stamped content. Click the button to define the hyperlink. The options to defineLinkthe hyperlink are similar to the ones found in the tool. However, the Destination Page options in this dialog box alsoText Quick Linker provide Previous Page and Next Page selections.

Page Stamper Link Dialog Box

Save Left/Center/Right Text

Select this check box to retain the selections made for the Left, Center, and Right text fields for the next time the dialog box is accessed.

Common

The selections made in this area of the dialog box will be applied to both header and footer stamps.

Apply Starting Chapter Number

Select this check box to set the starting chapter number as the number selected in the adjacent text field. This option is applicable only when

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the Chapter Number option is selected from the Type drop-down list.

Apply Starting Page Number

Select this check box to set the starting page number as the number selected in the adjacent text field. This option is applicable only whenthe Page Number option is selected from the Type drop-down list.

Pad with ___

Select this check box and enter a number in the adjacent text to have this number preceede the stamped content.

Number of Digits

Enter a number in this text field to indicate the number of digits that will preceede the stamp. For example, if the number 5 is entered in the P field and 3 is entered in the field, the header and footer stamps will be preceded by "555."ad with Number of digits

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PDF Correct

Page Content:


Correct PDF File(s)Details

Acrobat Distiller Settings PDF Correct Dialog Box - Options

Access

ToolBox > PDF Tools> PDF Correct

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Overview

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At times, PDF files may be malformed. If other tools do not seem to provide the anticipated results or an error is received, it may be due to amalformed PDF. Use this tool to correct the malformation of PDF files while retaining bookmarks, page stamps, hyperlinks, comments, andthe PDF rotation tags.

PDF Correct performs a low-level correction to a damaged PDF file. It is accomplished by printing the file as a PostScript and re-distilling itinto PDF. This document recovery technique is called "Refry."

In ToolBox, the "ISIPrinter", which is a driver-only software printer, is used to convert the malformed PDF into PostScript, then distill thePostScript and apply the PDF Correct tool options.

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PDF Correct Steps

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Save PDF As Dialog Box

This tool is designed to be used on a batch of files; therefore, it is not available in the mode.Batch

Examples

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Correct PDF File(s)

PDF Correct is designed to be used on multiple files simultaneously. The documents are selected after the tool is accessed, so docuementsdo not need to be open prior to using the tool. However, it is also possible to access the tool, if there are PDF documents already open (theywill not affect the PDF Correct process).

Access the tool.PDF CorrectClick on the button to browse to the appropriate location and select files that will need correction. Selected files willAdd Filesappear in the list box. (See the page for details on the Add Files and Add Directory buttons).Common FeatureClick the button to select the If the Output folder is the same location as the original folder, select the Ellipsis Output Folder. Same

check box.Folder

If the 'Same folder' option is selected, the entered output folder will be ignored, and the output pathwill be the sameas the source file path. A sequential number is added to the new file name.

Select the check box, click on the Ellipsis button, and browse to a location where the log file should be saved. Once the Log File PD process is completed, click on the button to open the file.F Correct View Log

A log is a text-based file of the changes made to the files in the list box.

Select Distiller Settings from drop-down list. See the Acrobat Distiller Settings details below.Select any of the following Options (see the section below for descriptions of each):Details

Keep HyperlinksKeep BookmarksKeep comments and markupsKeep from objectsKeep page roation tags (rotations may not be the same depending on Distiller settings)Delete Distiller log after the correction.

Enter the seconds in the text box. This is the amount of time that ToolBox will allow to attempt to correct the PDF issues. IfTimeoutthe file(s) cannot be fixed during this time, the process will be aborted. Enter "0" to indicate that there should be no timeout time.Click the button to start the process. A message will be displayed as shown in the image below.Start

PDF Correct Status MessageClick the button. The progress message dialog box will be displayed.OK

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PDF Correct Proress MessageA confirmation message will display to communicate that this process has been completed. "PDF Correct completed successfully".Click the button on the confirmation dialog box. The output documents are shown in the image below.OK

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PDF Correct Output Document

PDF Correct Log File

Details

Acrobat Distiller Settings

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Distiller Options

The PDF Correct tool allows for selection of the Adobe Distiller setting.The 2nd step of the Refry process is to distill the PostScript file back into PDF. To do this, ToolBox uses the Adobe Distiller. The output PDFcan vary depending on the Distiller setting. By default, "Standard" is selected. The available Distiller Settings and their description are asfollow:

Strandard: This setting is the default. Use these settings to create PDF documents suitable for reliable viewing and printing ofbusiness documents. The PDF documents can be opened with Acrobat and Adobe Reader 5.0 and later.High Quality Printing: Use this setting to create PDF documents for quality printing on desktop printers and proofers. The PDFdocuments can be opened with Acrobat and Adobe Reader 5.0 and later.Press Quality: Use this setting to create PDF documents with improved image resolution for high quality pre-press printing. ThePDF documents can be opened with Acrobat and Adobe Reader 5.0 and later. These settings require font embedding.Smallest File Size: Use this setting to create PDF documents with minimum image resolution and no font embedding. The PDFdocuments can be opened with Acrobat and Adobe Reader 5.0 and later.PDFX1a2001: (In Acrobat 6, this was the PDFX1a PDF settings file) Use this setting to create PDF documents that are to bechecked or must conform to PDF\X-1a:2001, an ISO standard for graphic content exchange. For more information on creating

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PDF/X-1a compliant PDF documents, please refer to the Acrobat Guide in Distiller online Help. Created PDF documents can beopened with Acrobat or Adobe Reader 4.0 and later.PDFX1a2003: Use this setting to create PDF documents that are to be checked or must conform to PDF/X-1a:2003, an ISOstandard for graphic content exchange. For more information on creating PDF/X-1a compliant PDF documents, please refer to theAcrobat Guide in Distiller online Help. Created PDF documents can be opened with Acrobat or Adobe Reader 5.0 and later.PDFX32002: (In Acrobat 6, this was the PDFX3 PDF settings file) Use this setting to create PDF documents that are to be checkedor must conform to PDF/X-3:2002, an ISO standard for graphic content exchange. For more information on creating PDF/X- 3compliant PDF documents, please refer to the Acrobat Guide in Distiller online Help. Created PDF documents can be opened withAcrobat or Adobe Reader 4.0 and later.PDFX#2003: Use this setting to create PDF documents that are to be checked or must conform to PDF/X-3:2003, an ISO standardfor graphic content exchange. For more information on creating PDF/X- 3 compliant PDF documents, please refer to the AcrobatGuide in Distiller online Help. Created PDF documents can be opened with Acrobat or Adobe Reader 5.0 and later

PDF Correct Dialog Box - Options

These are the options available in the PDF Correct dialog box.

Keep hyperlinks: If this option is selected, ToolBox will export the hyperlinks of the source document using an Excel format, andthen it will import the exported hyperlinks from the Excel file and create them into the output file. The exported file will be saved in thetemporary folder("C:\Documents and Settings\user account\Local Settings\Temp\ToolBox").Keep bookmarks: If this option is selected, ToolBox will export the bookmarks of the source document using an Excel format, andthen it will import the exported bookmarks from the Excel file and create them into the output file. The exported file will be saved inthe temporary folder("C:\Documents and Settings\user account\Local Settings\Temp\ToolBox").Keep comments and markups: If this option is selected, ToolBox will export the comments of source document to an FDF file, andthen it will import the comments into the output PDF file.The FDF file will be saved in the temporary folder("C:\Documents and Settings\user account\Local Settings\Temp\ToolBox").Do not print printable comments and markups in the output: If this option is selected, ToolBox will suppress prinitng commentsand markups.

Sometimes comments and markups are printed out with duplicates in the output, when "Keep comments andmarkups" checkbox is selected. The "Do not print printable comments and markups in the output" check boxensures that comments and markups are not duplicated in the output.

Keep form objects: If this option is selected, ToolBox will copy the AcroForm objects of source document into the output file.Do not print printable form objects in the output: If this option is selected, ToolBox will omit form objects in the printed output.

Sometimes objects are printed out with duplicates in the output, when "keep form object" check box is selected.The "Do not print printable form objects in the output" check box ensures that objects are not duplicated in theoutput.

Keep page rotation tags (rotation may not be the same depending on Distiller settings): Select this option to keep the page rotationtags of source document in the output file.Delete Distiller log after the correction: If this option is selected, ToolBox will delete the Distiller log after the correction iscompleted. If this option is not checked, a file named the same as the destination file with an extension log will be saved.

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Timeout: This edit box denotes the time that PDF Correct waits for the completion of the printing job (pdf to ps, by ISI Printer). If thetime expires for a file without proper response, the file will be skipped and the operation will move on to the next file.

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PDF Options

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Working with PDF OptionsDocInfo TabFile Open Options TabSecurity Tab

DetailsPDF Options Dialog BoxDocInfo TabFile Open Options TabSecurity Tab

Access

ToolBox > PDF Tools> PDF Options

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Overview

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Use this tool to modify Acrobat document properties, set file opening settings, and set security options in one or more documentssimultaneously. This eliminates the need to open each file individually to modify the settings.

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PDF Options Dialog Box

This tool is designed to be used on a batch of files, therefore, it is not available in the tool.Batch

Examples

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Working with PDF Options

Because the PDF Options dialog box contains three tabs, this example has been divided into three sections - one for each tab.

DocInfo Tab

Access the tool before opening the PDF files to be worked.PDF OptionsClick either the or button. (See the page for details on these buttons. Details on theAdd Files Add Directory Common Features Remove Files, Sort Files, Load List, and Save List buttons are also included in the Common Features page.)Navigate to and select the files or directory that contains the files to be worked. The files will be listed in the top portion of the PDF

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Options dialog box and all of the files will be selected.Ensure the tab is selected in the bottom portion of the dialog box. The values in the , , ,Doc Info Creator Producer CreationDateand fields are pulled for each document from the Acrobat Document Properties dialog box (File > Document Properties –ModDateas shown in the screenshot below). These values (Creater, Producer, CreationDate, and ModDate) cannot be modified. If theproperties are different in each document, the word VARIANT is displayed in the Value field in the PDF Options dialog box.

Adobe Acrobat Document Properties Dialog Box - Description TabDocument Property fields that can be modified can be pulled into the list, as well. Click one of the drop-down arrows in the PDFOptions dialog box and select one of the options ( , , , or ). If a property has a value it will be populatedTitle Subject Author Keywordin the Value column. If the value is different for all selected documents, then VARIANT will be displayed as the value.

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Doc Info Tab Showing Properties with Common Values and Variant ValuesTo modify the , double-click on the field and enter the appropriate information. Note: If a VARIANT value is modified, the valueValuewill then be the same for all listed documents.A custom field and value also can be added. Click in an empty field and type in the title. Then click in the adjacent Field Name Valu

field and type in the appropriate value. In the screenshot above, “custom field” and “custom value” were used as an example. Noteethat once a custom field is added, it will become available in the drop-down box.Ensure that the radio button is selected and click the button to save the modificationUpdate document information Write DocInfoto the document’s properties. The modifications will be reflected in the Acrobat Document Properties dialog box for all selecteddocuments. The standard fields can be seen in the tab. Click the tab to view any custom fields and values thatDescription Customwere added.

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Adobe Acrobat Document Properties Dialog Box - Custom Tab

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This process can be performed on a subset of the documents that were added to the list. Select one or more of thedocuments and follow the same steps as outlined above. If only one document is selected, the VARIANT value will notdisplay.

If a change is made or a custom property is added, the change will be reflected only in the selected documents.

PDF Options Dialog Box - Doc Info Tab with One Document Selected (VARIANT does not display as a Value)

File Open Options Tab

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If the PDF Options dialog box is not open and files have not been loaded, perform steps 1-3 in the DocInfo Tab example above.Click on the tab.File Open OptionsSelect the options to be applied when the file is opened. Regulatory guidelines recommend that the Initial View setting be Bookmarkand Pages, and that the Magnification and Page Layout be set to Default. See Details below for descriptions of the options.

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PDF Options Dialog Box - File Open TabClick the button. The options will be set for all selected documents.Apply

Security Tab

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If the PDF Options dialog box is not open and files have not been loaded, perform steps 1-3 in the DocInfo Tab example above.Click on the tab.SecuritySelect the options to be applied when the file is opened. Regulatory authorities prohibit the use of security settings on submissiondocuments. See Details below for descriptions of the security options.

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4. PDF Options Dialog Box - Security TabClick the button. The security will be set for all selected documents.Apply

Details

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PDF Options Dialog Box

View PageClick this button to display the selected document in a pane that extends off the side of the PDF Options dialog box. Navigationbuttons are provided at the bottom on the pane so that each page of the document can be viewed. Viewing the document whensetting options helps to ensure that the settings are applied to the appropriate documents.

DocInfo Tab

Refresh Button Click this button to update the values in the Document Information Values. This button is enabled only when the Read documentinformation radio button is selected.

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Read document information Radio buttonWhen this radio button is selected the Document Information fields are locked and changes cannot be made.

File Open Options Tab

Initial ViewOptions in this area of the dialog box are used to set the view of the PDF document when it initially opens. The Acrobat environment provides a left pane to be opened. Tabs along the left edge of the environment allow for various elementsto be displayed in that pane. The radio button selected in this area designates which element will be displayed in the left pane whenany of the selected PDF documents are opened. Regulatory guidelines recommend that Bookmarks and Pages be displayed when adocument initially opens.Open toSelect this check box and enter a page number in the adjacent text field to initially open any of the selected PDF documents to thatspecific page.MagnificationSelect this check box and a setting from the drop-down list to initially open any of the selected PDF documents to a specificmagnification.Selecting Default will maintain the user's setting. (This is the magnification that was in use prior to opening thedocument.)Page LayoutSelect this check box and a setting from the drop-down list to initially open the PDF documents to a specific layout. The options areDefault, Single Page, Continuous, Facing, and Continuous Facing. Selecting Default will maintain the user's setting. (This is thelayout that was in use prior to opening the document.)Window OptionThe options in this area (Resize Window To Initial Page, Center Window On Screen, and Open in Full Screen Mode) will set theAdobe Acrobat environment to the selected option when any of the selected PDF documents are opened. For example, if theMagnification were set to 50% and the Resize Window To Initial Page were set as the Window Option, then the Acrobat environmentwould be resized to fit around the page display.User Interface OptionsThe options in this area (Hide Menu Bar, Hide Toolbar, Hide Window Controls) will set the Adobe Acrobat environment to display orhide the corresponding item when any of the selected PDF documents are opened.

Security Tab

Specify Password ToEntering a password in the field (and Confirm Open Password field) would then require a password to beOpen the documententered before the document can be opened.Entering a password in the field (and Confirm Permission Password) would then require a password to be enteredChange Securityto change security settings.If Security had already been added to documents (either through the PDF Options dialog box or through Acrobat's DocumentSecurity options) then they can be removed by clearing these fields. However, if a password had been assigned for the ChangeSecurity option, entering that password would be required to change or remove passwords.

Do Not AllowSelect any of these check boxes to restrict the ability to perform these tasks (Printing, Change the Document, Content Copying orExtraction, and Adding or Changing Notes and Form Field). If these restrictions had already been selected (either through the PDFOptions dialog box or through Acrobat's Document Security options) they can be allowed by clearing these check boxes. However, ifa password had been assigned for the Change Security option, entering that password would be required to make changes to thesesettings.

Export ButtonClick this button to save the security settings applied to the document as an Excel or CSV file. This could be usefulfor communicating security settings that should be placed on PDF documents.

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Save PDF As

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Saving PDF Files as Another File TypeDetails

Show config dialog

Access

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ToolBox > PDF Tools> Save PDF As

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Use this tool to convert multiple PDF documents to a different file type (such as TIFF). This process is the same as using the Save As optionin Acrobat, except with the added benefit of performing the task on multiple documents simultaneously.

Save PDF As Dialog Box

This tool is designed to be used on a batch of files; therefore, it is not available in the mode.Batch

Examples

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Saving PDF Files as Another File Type

Without opening the PDF files to be worked, access the tool.Save PDF AsClick either the or button. (See the page for details on these buttons. Details on theAdd Files Add Directory Common Features Remove Files, Sort Files, Load List, and Save List buttons also are included in the page.)Common FeaturesNavigate to and select the files or directory. The files will be listed in the top portion of the Save PDF As dialog box and all of the fileswill be selected. Click to deselect individual files that are not to be converted.Select the to which the PDF files will be converted. The options include: TIFF, Microsoft Office Word, JPEG, and XML.File Type

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If TIFF is the selected File Type, selecting the check box will convert and save each PDF file as aUse multi-tiffseparate TIFF file. If the check box is selected, all PDF files will be converted to TIFF files, but files would not bemerged. If this check box is not selected, all PDF files will be converted to TIFF files, and the total number of TIFFfiles would depend on the number of pages in individual PDF documents merged. To change the order, select afile and then use the use the arrows above the list to rearrange the files. (See the page forCommon Features details on the arrow buttons.)

If the files should be saved to a location different from the source files, click the ellipsis ( ) button next to the field and… Directoryselect the appropriate location. If the files should be saved in the same location as the source files, select the Save in the original

check box. The Directory field will be disabled.pathIf the files should be saved with a different name, enter that name into the field. Each file converted will be saved withFile Namethat name with a sequential number placed at the end. (For example, NewFile_0, NewFile_2, NewFile_3, …) If the files should besaved using the original name, select the check box.Use original file nameClick the button. If the Show config dialog check box was selected, the Save As Settings dialog box for the selected file typeStartwill display. (See below.) Select the file type configurations as needed. All files listed in the Save PDF As dialog box will beDetailsconverted to the selected file type.

Details

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Show config dialog

Select this check to open the Save As Settings dialog box once the Start button is clicked. The dialog box contains selectable options, whichdiffer depending upon the selected file type. Below are two examples of the Save As Settings dialog box, one for TIFF and one for DOC filetypes.

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Examples of the Config Dialog Boxes

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Scale PDF

Page Content:


Scaling by Percentage or by Paper SizeScaling Page Content by Margin

DetailsPaper Size Options

Access

ToolBox > PDF Tools> Scale PDF

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Overview

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Use this tool to resize selected PDF document pages or to scale down the content. Scaling down the page content can be useful to ensureadequate margins (ie, when stamping header and footer content). Resizing a page can be useful to change letter-size documents to A4-sizeddocuments.

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Scale PDF Dialog Box

This tool is available in the mode.Batch

Examples

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Scaling by Percentage or by Paper Size

There are three methods to choose from when scaling a document. It can be done by percentage, by paper size, or by a set margin. TheScale by percentage and the scale by Paper options will be used in this example.

Access the tool.Scale PDFTo reduce or enlarge by a specific percentage, select the radio button and then select a percentage from the adjacentScaledrop-down list. To change to a specific page size, select the radio button and then select a page size from the adjacentPaperdrop-down list. The page size options include envelope sizes, as well. See the Details below for all page size options.Select a . The options are:Scale Option

Page Only – select this option to reduce or enlarge only the page. For example, an 11 x 17 inch page can be reduced to an8 ½ x 11 inch page by selecting 50% from the percentage drop-down list. This is not a typical scenario, however. In mostinstances, if the page size is reduced significantly, objects on the page will need to be reduced, as well. If this is the case,select Page and Objects.Objects Only – select this option to reduce or enlarge only the content of the page. The page size will not change.Page and Objects – select this option to reduce or enlarge both the page and the content of the page.

Select the . (See the Common Features page for details on Page Range.) Caution should be taken when scaling morePage Rangethan just the Current page, however. Ensure that all pages should be reduced or enlarged before selecting or a range of .All PagesClick the button. The selected options will be applied to the document. The dialog box will remain open for additional scalingStartneeds.

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Before and After Examples of the *Objects Only* Reduced 75%

Scaling Page Content by Margin

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The option to scale the page content to fit within a specific margin is useful when needing to stamp a header and/or footer to a page. Ifscaling for this reason, see the Page Stamper tool for details on stamping headers and footers.

The Margin scale option affects only the page content, which can be reduced but cannot be enlarged.

.

Access the tool.Scale PDF

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Scale PDF Dialog Box with the Margin Option SelectedSelect the radio button and select the , , , and margins. A blue ruling line is displayed on theMargin Top Bottom Left Rightdocument as a visual indication of the selected margin settings.Select the . (See the Common Features page for details on Page Range.) Caution should be taken when scaling morePage Rangethan the Current page. Ensure that all pages should be reduced or enlarged before selecting or a range of .All PagesClick the button. The selected options will be applied to the document. The dialog box will remain open for additional scalingStartneeds.

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Before and After Examples of the Page Contents Reduced to Fit Within a Specified Margin

Details

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Paper Size Options

When scaling by Paper, the options available are:

A3A4A5LetterB4 (JIS)B5 (JIS)Envelope #10Envelope C5Envelope DLEnvelope MonarchExecutiveLegal

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Search & Replace

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Finding and Replacing TextManaging Highlights

DetailsSearch & Replace Dialog Box

Use delimiterWhole words onlyCase sensitiveUse wildcardAuto-size text to fit redaction regionUse different fontUndo Button

Search & Replace - Manage Highlights Dialog Box Status Drop-Down List

Access

ToolBox > PDF Tools> Search & Replace

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Overview

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Use the Search and Replace tool to find instances of specified text, and then to replace that text either with new text or with a coloredrectangle (similar to ). All instances of one or several keywords can be replaced simultaneously or individually. The tool asloiRedactfacilitates the process of finding words and highlighting them so that a workflow procedure of reviewing changes prior to making them can beimplemented.

This tool can be used only on text-based documents.

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Search & Replace Dialog Box

This tool is available in the mode.Batch

Examples

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Finding and Replacing Text

Text can be replaced with alternate text or with a colored rectangle. The colored rectangle acts in the same manner as in the tool,iRedact where the text is cover permanently.

Access the tool.Search & ReplaceSelect the radio button.Search & ReplaceEnter the search text in the field.Find whatChoose the option.Replace WithSelect the radio button to replace the search text with different text, and then enter the replacement text in the adjacent textTextfield. The number of characters in the replacement text cannot exceed the number of characters in the search text.Select the radio button to replace the search text with a colored rectangle, and then select a color from the drop-downRectanglelist. This is similar to using the tool.iRedactChoose the method.ChangeSelect the radio button to view each instance of the found text. Click the button to view the nextChange one by one Find nextinstance of the found text (the appropriate page of the document will be displayed and the text will be outlined with a red dotted line).Click the button to make the change, or click the button to leave as is and view the next found instance of theReplace Find nextsearch text.

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When the option is selected, it is not necessary to perform the remainder of steps in thisChange one by oneexample process.

Select the radio button if it is desired to change all instances of the search text, and then select theChange Page by Rangeappropriate page range option. (See the page for details on Page Range.) This will gather and present a listing ofCommon Features all found instances of the search text as shown in the Results of Search Dialog Box screen shot below. See the sectionDetailsbelow for more information about the area of the Search & Replace dialog box.Options

If a page range was selected, click the button. A progress message box is displayed as the search process takes place. WhenStartthe search process is completed, the Results of Search dialog box will be displayed listing each found instance of the search textalong with the page number where it is found.

Search & Replace - The Results of Search Dialog BoxIf all found instances should be replaced, leave all check boxes selected and click the button. If there are any that shouldReplacenot be replaced, clear those check boxes and then click the button.ReplaceIf unsure or if it is necessary for someone else to review prior to changes being made, click the button. This will place redHighlighthighlighting over each found instance of the search text. A reviewer then can follow the Managing Highligts process below to vieweach highlighted instance and make a decision to change or not to change.If the button is clicked, the replacement will take place and a message will be displayed indicating the number ofReplacereplacements made.If the button is clicked, a subsequent dialog box will open that allows for a status setting to be selected. The options areHighlight

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None, Accepted, Rejected, Cancelled, and Completed.Once the staus is set and the button is clicked, the highlights will be made and a message will be displayed indicating theOKnumber of highlights made.

Search & Replace - Highlight Status Dialog Box Showing Set Status

Example of Highlight Search Text - Mouse Over to View the StatusSave the document. If the highlight feature was selected, the document will be saved with the highlights. The reviewer can thenfollowing the process below to manage the highlights.

Managing Highlights

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Follow this process to review each highlighted instance of the search text before changes are made, assign a status, and/or remove thehighlighting as needed.

With the searched and highlighted document open, access the tool.Search & ReplaceSelect the radio button.Highlights

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3. Search & Replace Dialog Box with the Highlights Radio Button SelectedClick the button. (This button is enabled only when the Highlights radio button is selected.) The Search &Manage HighlightsReplace – Manage Highlights dialog box is displayed, listing each highlighted instance of the search text, along with the Status andPage number.

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Search & Replace - Manage Highlights Dialog BoxTo view the highlighted instance, select a line from the list. The page will be displayed and the specific instance will be outlined witha blue dotted line.There are now several options that can take place.

Replacing Instances of the Search Word:If all instances of the search word should be replaced, select the and the radio buttons. Then, click the buReplace All Starttton.If only certain instances of the search word should be replace, clear the check boxes of the instances that should not bereplaced, then select the the radio buttons. Click the button.Replace Check items StartFor either selection, the process will run and the Manage Highlights dialog box will close; however, the Search & Replacedialog box will remain open so additional tasks can be completed, if necessary. Removing highlights from the Search Words:To remove the highlighting from all instances of the search word, select the and the radio buttons.Remove Highlights AllClick the button.StartTo remove the highlighting from only certain instances of the search word, clear the check boxes of the instances thatshould not be removed, then select the and the radio buttons. Click the button.Remove Highlights Check items StartFor either selection, the process will run and the Manage Highlights dialog box will close; however, the Search & Replacedialog box will remain open so that additional tasks can be completed, if necessary.To Change the Status:If the status for all instances of the search word should be changed, select the and the radio buttons.Change status AllSelect the appropriate status from the drop-down list. Click the button.Change status to StartIf the status for only certain instances of the search word should be changed, clear the check boxes of the instances that

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should not be changed, then select the and the radio buttons. Select the appropriate statusChange status Check itemsfrom the drop-down list. Click the button.Change status to StartFor either selection, the process will run and the Manage Highlights dialog box will close; however, the Search & Replacedialog box will remain open so that additional tasks can be completed, if necessary.

Details

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Search & Replace Dialog Box

Use delimiter

To search and replace multiple words in a document, select this check box and select a delimiter option from the adjacent drop-down list(comma, colon, semicolon, or space). Once a delimiter is selected, enter the search words in the text field separated by theFind whatchosen delimiter. (For example, if BrainO; BrainX; BrainY were entered, then all of these terms will be replaced with either the replacementtext or the redaction rectangle.)

Whole words only

Select this check box to search and replace only when the whole instances of the search word is found. (For example, if BrainO were thesearch word, BrainOcilian would not be replaced if this check box were selected.)

Case sensitive

Select this check box to search only for instances of the search word that match the case used in the text field.Find what

Use wildcard

Select this check box to use a wildcard character in the field. The supported wildcard characters are:Find what

* - An asterisk “*” will match any number of characters and can be used anywhere in the text string. For example, if “Figure 1.*2” isthe search text, then the results may include “Figure 1.12”, “Figure 1.2.2, Figure 1.2222” etc.? - A question mark “?” will match a single alphabetic character and can be used anywhere in the text string. For example, if B?ll isthe search text, then the results may include, Ball, Bill, Bell, etc.

Auto-size text to fit redaction region

When replacing with text, select this check box to adjust the kerning (spacing between the letters) so the replacement word fits nicely into thespace.

Use different font

Select this check box and click the Font button to choose a specific font for the replacement text. This is mainly used if the document fontdoes not exist in the current operating system.

Undo Button

Click this button to remove the last replacement or redaction applied to the dialog box. Once the dialog box is closed, however, this optionwill no longer be available.

Search & Replace – Manage Highlights Dialog Box

Status Drop-Down List

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Search & Replace Dialog Box Showing Status options

Once various status options have been assigned, the list can be filtered by selecting a specific status from this drop-down list. The list withinthe dialog box will refresh and display only those instances that have the selected status applied.

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Advanced ToolsThe tools described in this section are used to gather information, create, merge, and split PDF files, as well as create a TOCand compensate for page numbering schemes that do not match the PDF page numbering.


EZPDF MakerSplit PDFMerge PDFPage MapperTOC BuilderRotation ManagerPDF Information


EZPDF Maker

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Converting Multiple Files to a Single PDF FileConverting Specific Excel Worksheets to Individual PDF Files

DetailsWrite to multiple filesDo not add a root bookmarkTimeout

Access

ToolBox > Advanced > EZPDFMaker

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Overview

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Use this tool to convert multiple file types (such as Word, Excel, Text, etc) to a PDF file. Options are available to merge multiple source filesinto a single PDF, or to create separate PDF files for each source file.

EZPDFMaker Dialog Box

Examples

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Converting Multiple Files to a Single PDF File

Access the tool.EZPDFMakerClick on the button to browse to the appropriate location and select files to be converted to a PDF file. Selected files willAdd Filesappear in the list box. (See the page for details on Add Files and Add Directory buttons).Common Features

A combination of various file types and PDF files can be added when merging them in a single PDF file. Files willbe merged in the order they are added in the list box. Use the Arrows to change the order of files. See the Commo

page for details on Arrows.n Features

Select the radio button to merge all files into a single PDF file. (See the section for Write to multiple fileWrite to a single file Detailsoption.)Click on the ellipsis ( ) button adjacent to the field to select a folder location where the output PDF file will be saved and to… Fileprovide a name for the PDF file.Optionally, select the check box to view the output PDF file.Open the destination PDF file after the conversion has completedSelect the radio button in the group box. This option will create a root bookmark (level 1File name Title of Root Bookmarkbookmark) for each source file in the output PDF, indicating where each source file began and ended. The file name of each sourcefile will be used as the bookmark title.

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When bookmarks are included in a PDF it improves the navigation of the PDF documents. Regulatory guidancerecommends that PDF files with a table of contents provide bookmarks and hyperlinks for each table entry.Regulatory guidance also recommends using no more than 4 levels of heading in the TOC and bookmarkhierarchy.

Click the button to start the conversion process. A confirmation message will display to communicate that the conversionStartprocess has been completed.Click the button on the confirmation dialog box. The output PDF file will open.OK

Example of the Single Output PDF with Root Boookmarks

The output PDF file will retain the original paper size.

Converting Specific Excel Worksheets to Individual PDF Files

Add the appropriate files.Select the radio button and select a folder location where each PDF file will be saved. The original file nameWrite to multiple filesand the worksheet name will be used to create each output PDF file title.

If the Write to a single file radio button is selected, a folder location and a file name for the output PDF must beprovided. The file name will be used to create the output PDF file that will merge the selected worksheets in asingle PDF file. Additionally, the root bookmark for each worksheet can be created in the PDF.

Next, select the check box.Excel: Choose which worksheets to printClick the button. The EZPDFMaker - Worksheet dialog box will open. This dialog box will list the worksheet name(s).Start

Only worksheets containing data will be listed for selection in this dialog box.

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EZPDFMaker - Worksheet Dialog BoxSelect a worksheet to convert to PDF and then click the button. If more than one worksheet is listed, a confirmation message willOKdisplay asking if another worksheet should be selected.

Confirmation MessageClick the button to select another worksheet or click the button to continue with the conversion process.Yes No

If more than one Excel file is selected, then EZPDFMaker will go through the worksheet selection process for eachExcel file.

A confirmation message will be displayed after the conversion process is completed. Click the button on the confirmation dialogOKbox.

Example of Individual Output PDFs for Excel Worksheets

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The output PDF file will retain the original paper size.

Details

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Write to multiple files

Select this radio button to convert each source file into a separate PDF file. Then, click on the ellipsis (…) button adjacent to the Directoryfield to select a folder location where each PDF file will be saved. When this option is selected, the options in the Title of Root Bookmarkgroup box will be disabled. Root bookmarks can only be added when more than one document is being merged into a single PDF file. Tofinish the conversion process, click the Start button.

If a PDF file(s) is selected for the conversion process, a message will display to communicate that the file type is alreadyPDF and it will not be converted again.

Do not add a root bookmark

When this radio button is selected a root bookmark will not be inserted in the output PDF file(s).

Timeout

The number entered in this field is used to determine time limits (in seconds) for the conversion process for each file. A message will bedisplayed if conversion for the current file is taking longer than the length of time specified. Information about skipping the conversion processfor the current file is also included in this message.

Timeout Confirmation Message

To acknowledge the message and continue the conversion to PDF, click the button on the message box. The file will be converted into aOKPDF file.

To acknowledge the message and omit the file from the conversion process, click the button and click the button on theOK SkipEZPDFMaker dialog box. The file will not be converted into a PDF file.

The Cancel button in the EZPDFMaker dialog box temporally changes to the Skip button.

Split PDF

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Splitting a PDF by BookmarkDetails

Split by BookmarkSplit by Page RangeSplit by File SizeSplit by SectionsDo not include original file bookmarks in split PDFsFile Naming Control with Reset Button

Access

ToolBox > Advanced > Split PDF

Or

Overview

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Use this tool to split a single PDF file into multiple PDF files based on a selected bookmark level. Destinations for all bookmarks andhyperlinks are adjusted to ensure they maintain accuracy after the splitting process.

Files can be split by sections, file size, or by a range of pages. See the sections to learn about these options.Details

The options and settings selected in the Split PDF dialog box will be remembered when this dialog box is closed and thenreopened. Ensure that the options and settings are reviewed and set appropriately prior to splitting another PDF file.

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Split PDF Dialog Box

Example

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Splitting a PDF by Bookmark

Open the PDF file that will be split into multiple PDF files. The PDF must contain internal bookmarks.Access the *Split PDF* tool.Select the *Split by Bookmark* radio button and select a level (eg, 1) from *Bookmark Level drop-down* list. The levels displayed inthis drop-down list are dependent on the bookmark structure in the open PDF. In the below screenshot, the open PDF bookmarkstructure displays two levels: level one and level two bookmarks.

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PDF File with a Bookmark StructureAt times documents contain introductory pages (eg, cover or title pages) for which there are no bookmarks. In these cases, aseparate preface file can be created. By default, the *Preface File Name* is *Preface*, however, this file name can be changed ifdesired. The file name will also be used to create a level one bookmark in the output PDF file.

The preface file will not be created if all content in the source PDF file is bookmarked.

Examples of Introductory PagesClick on the ellipsis ( ) button adjacent to the *Directory* field to select a folder location where the output PDFs will be saved.…Click the button to use the original file name and bookmark name to create each output file. See the - Reset Details File Naming

section for more information.Control with Reset Button

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If a new file name is preferred, simply enter the name in the field. If a file name is not provided, thenFile Nameonly the bookmark title will be used to create each file title.

Click the *Start* button to begin the splitting process. When completed, a confirmation message will display to communicate that thesplitting process is finished.Click the *OK* button on the confirmation dialog box.

In this example, level one bookmark was selected to split the open PDF. Each output split PDF file will contain thelevel one bookmark and all child bookmarks associated with it.

Example of Output Split PDFs by Level One Bookmark

Details

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Split by Bookmark

The following options are enabled only when the radio button is selected:Split by Bookmark

Preface File Name - Use this text field to enter a new name for the preface file.Merge duplicate bookmark names into a single PDF - If there are duplicate bookmarks in the source PDF, select this option tomerge all duplicate bookmarks accordingly into their respective output PDF file.Retain the original bookmark structure in each PDF - Select this option to maintain the entire bookmark structure in each outputPDF file. Bookmark destinations will be adjusted accordingly.

Split by Page Range

Select this radio button to split the open PDF file into volumes (sets of pages). The number of pages in each volume is determined by thenumber entered into the *Split by Page Range* field. To create each volume with an equal number of pages, ensure the *Split volume withsame number of pages* check box is selected.

To create different size volumes, uncheck the *Split volume with same number of pages* check box and then enter adifferent page range (eg, 5, 15, 25) in the Split by Page Range field.

Split by File Size

Select this radio button to split the open PDF file based on the file size entered in the *File Size* field. For example, if 1024 is entered in this

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field, the open PDF will be split into separate PDF files that are 1,024KB each.

Split by File Size section

Split by Sections

Select this radio button to split PDF file by sections. Selecting this radio button will enable both the Create sections button and the Deletesections in original file check box.

Click the *Create sections* button to open the Split PDF -- Create Section dialog box. Click the *Add Section Mark* button to automaticallyassign a section name and page range. To define the pages in each section, double-click directly on the numbers in the *From* and *To*columns respectively. This will make the field editable. Enter a different page number in the appropriate column. When finished addingsections, click the *Apply* button to use those section marks to split the open PDF.

Select the *Delete section in original file* check box to delete the section marks from the open PDF document after the splitting process iscompleted.

Split PDF - Create Sections

Do not include original file bookmarks in split PDFs

This check box is only enabled when the Split by Page Range, Split by File Size, or Split by Sections radio button is selected. When selected,the original file’s bookmarks will not be added into the split PDF files.

File Naming Control with Reset Button

The field is able to accept some variables enclosed by "< >" characters. (Note that "< >" are unusable characters for a normalFile NameWindows file name). Any other characters that are not enclosed in "< >" will be shown in the file name as they are.

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File Name Control Resent Button

For example, using this format string "<fn> P<0spn>", will name the output file "Document P012-P084.pdf". Whereas, if the format is "fixedname P<spn> CSC <idx>", the output file name will be "fixed name P34 CSC 3.pdf". The available variables are as follow:

<fn>: Original file name.<spn>: Starting page number for this split.<0spn>: Starting page number for this split with leading zeros.<epn>: Ending page number for this split.<0epn>: Ending page number for this split with leading zeros.<idx>: Sequential index from 1.<0idx>: Sequential from 1 with leading zeros.<bk>: Bookmark title, applicable only when "Split by Bookmark" is selected.

The numbered variables with an option of keeping leading zeros, "<0spn> and <0epn> must be based on the number of digits in the totalpages. See more details in the below image where the original file contains 1142 pages, "Split with page range" is set as 93, and the result ofthis splitting as shown in images below.

Split PDF Dialog Box - Split by Page Range

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Folder Showing Splitting DocumentsThe button will reset the format text to the default value. To be consistant with ToolBox, the default will be as follow:Reset<fn> <bk> when Split by Bookmark option was selected.

.<fn> P<0spn>-P<0epn> for all other option. (Note that "#" was replaced with "P")

Merge PDF

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Merging Multiple PDF FilesDetails

Root Bookmark CreationCreate section marks

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Overview

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Use this tool to combine multiple PDF files into a single PDF. Destinations for bookmarks and hyperlinks will be adjusted accordingly toensure accurate destinations in the merged PDF file.

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The options and settings selected in this dialog box will be remembered when this dialog box is closed and then reopened.Ensure that the options and settings are reviewed and set appropriately prior to merging PDF files.

Merge PDF Dialog Box

Example

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Merging Multiple PDF Files

Access the tool.Merge PDFClick on the button to browse to the appropriate location and select files to be merged into a single PDF file. Selected filesAdd Fileswill appear in the list box.

Files will be merged in the order they are added in the list box. Use the buttons to organize the files in theArrowappropriate order or click the button to organize the files in alphabetical order. See the Sort Files Common

page for details on Arrows, Add Files, and Add Directory buttons.Features

Click on the ellipsis ( ) button to select a folder location where the output PDF will be saved and to provide aFile Destination …name for the PDF file.Select the radio button to maintain the original bookmarks in the merged PDF file. (See the seDo not add a root bookmark Detailsction to learn about other options in the Root Bookmark Creation group box).Select the check box to view the output PDF file.View PDF file after merge has completed

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Click the button to start the merging process. When completed, a confirmation message will display to communicate that theStartmerging process has been finished.Click the button on the confirmation message. The output PDF file will open.OK

Details

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Root Bookmark Creation

Do not add a root bookmark - Select this radio button to not create room bookmarks for the merged PDF document.Retain bookmarks of the first file – This check box is only enabled when the Do not add a root bookmark radio button is selected.Selecting this check will include bookmarks only from the first file in the list box. Additionally, a root bookmark (level 1 bookmark) willbe automatically inserted in the output PDF. All bookmarks from the source PDF will be listed under the root bookmark as childbookmarks in the output PDF file. The root bookmark title will be based on the file name of the source PDF file.

If the first file in the list box does not contain bookmarks, then Merge PDF tool will look for the next PDF file in listbox that contains bookmarks and include bookmarks from that file in the output PDF file.

When an option from the below list is selected, a root bookmark (level 1 bookmark) will be created for each file thatwill be merged into a single PDF file. The bookmarks will indicate where each source file began and ended in themerged PDF file.

Use the file name for each PDF – Select this radio button to create a level 1 bookmark for each file that that will use the file nameas the bookmark title in the merged PDF file.Use the file path and name for each PDF – Select this radio button to create a level 1 bookmark that will use each file’s path andfile name in the merged PDF file.Use the Title from the doc info for each PDF – Select this radio button to create a level 1 bookmark that will use the text enteredin the Title field of Adobe Acrobat’s Document Properties dialog box.Use the Subject from the doc info for each PDF – Select this radio button to create a level 1 bookmark that will use the textentered in the Subject field of Adobe Acrobat’s Document Properties dialog box.

In Adobe Acrobat, click on the menu and select to open the Document Properties dialog box andFile Propertiesview the information in the Title and Subject fields.

Create section marks

Select this check box to create section marks for each file in the merged PDF file.

During the merging process, each file’s page range will be read and that page range will be marked as a section in themerged PDF. The Section Mark information will be stored as metadata in the merged PDF. These section marks then canbe used to split the merge PDF files again into each separate PDF file. The section marks can be viewed in the Split PDF –Create Sections dialog box of the tool.Split PDF

Page Mapper

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Mapping Pages in a PDF DocumentDetails

Scan OptionsLines to scan at top of pageLines to scan at bottom of page

Remove

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ToolBox > Advanced > Page Mapper

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Overview

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Use this tool to map non-Arabic numeral page numbers (such as Roman numerals) to the associated PDF page count number in a PDFdocument.

Page Mapper Dialog Box

Examples

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Mapping Pages in a PDF Document

In this example, the PDF document uses Roman numerals (ie, I, II, III, IV, etc) for introductory page numbers and Arabic numerals (eg, 1, 2,3, 4, etc) for the remaining page numbers. Notice that all pages are labeled with Arabic numerals in the Pages pane and Page Navigation barin Adobe Acrobat. After the mapping process is completed, however, the document pages originally numbered with Roman numerals will belabeled with the appropriate Roman numeral.

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Example of Document Page Numbering without Page Mapping Applied

Open the PDF file that uses non-Arabic numbers for document page numbering.Access the *Page Mapper* tool to open the Page Mapper dialog box.Select the *Scan options* radio button and then select the *Select location directly* radio button. This will enable the adjacent *SelectArea* button.

Other scanning criteria can be selected to scan spaces at either the top or bottom of the PDF page. See the[Details|#details] section for more information.

Click the *Select Area* button to change the cursor into an area selection tool. The Page Mapper dialog will temporarily close.Draw a box around an area of the page where the page numbers reside. Immediately after the area is selected, the Page Mapperdialog box will reopen.

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Example of Area SelectionSelect the *Create Page Labels* check box to display the mapped pages (with the Roman numeral page numbering) in the Pagespane and Page Navigation bar in Adobe Acrobat.Click the *OK* button. The document pages that originally were using Roman numeral page numbering will be converted and labeledwith the appropriate Roman numeral mapping.

Example of a Document Page Numbering with Page Mapping Applied

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8. If necessary, do one of the following:

Use the tool to bookmark and/or hyperlink existing TOC entries. The Roman numeral page numbering willTOC Bookmarks & Linksbe properly bookmarked and hyperlinked to the appropriate pages.Use the tool to create a table of contents (TOC) (if one already does not exist). The TOC will use the mappingTOC Builderinformation to generate the page numbers for the TOC entries. This means that Roman numerals will be used as the page numbersfor pages that are using Roman numerals in the TOC entries. And, if the option to create hyperlinks is selected, then TOC entries willbe hyperlinked to the correct destinations.

The FDA requires that all submission files contain bookmark and hyperlink navigation for the TOC. The CDERdivision of the FDA recommends that the hyperlink text color is black with a thin, visible rectangle surrounding thetext. The CBER division of the FDA requires that the hyperlink text color is blue and that the line type is invisible.

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Scan Options

The following two options are enabled when the *Scan options* radio button is selected in the Page Mapper dialog box:

Lines to scan at top of page

Enter the number of lines that will be scanned at the top of the PDF page in this edit box. Up to four lines at the top of the page can bescanned to search for unrecognizable page numbers.

Lines to scan at bottom of page

Enter the number of lines that will be scanned at the bottom of the PDF page in this edit box. Up to four lines at the bottom of the page canbe scanned to search for unrecognizable page numbers.

Remove

Select this radio button to remove existing page mapping from the open PDF document. Selecting this radio button will enable the Remove check box.the page labels

Select the check box to remove any existing page labels from the open PDF document.Remove the page labels

TOC Builder

Page Content:


Generating a TOC by BookmarksModifying Titles, Styles, and Fonts

Setting the TOC Title InformationSetting the TOC Level Information

DetailsMultiple Documents, Select DocumentsFrom ItemFrom StylePreviewPage JustificationInsert Page NumberFill Background ColorInsert Section NumberSet Page & AreaUse Destination Editor

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Use this tool to create a Table of Contents (TOC) for a single PDF or multiple PDF documents with either no TOC, or with an existing TOCthat no longer is accurate. The TOC can be created as a new document or can be inserted into an existing document.


TOC Builder Dialog Box

Examples

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Generating a TOC by Bookmarks

This example assumes that the bookmark structure already exists in the PDF(s) that will be used to create a TOC.

Access the tool.TOC BuilderSelect the radio button to create a TOC for the open PDF document. If the intent is to create a TOC for multipleCurrent documentdocuments, select the radio button and click on the button to add files. (See the Multiple documents Select Documents… Detailssection for more information.)Select the radio button and then select from the drop-down list. This will create the TOC based on theFrom Items Bookmarksbookmarks in the PDF(s).

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If the Multiple Documents radio button is selected, more options will be listed in the drop-down list. SeeFrom Itemthe section for more information.Details

Select the check box and each appropriate check box below. (These are located below the button.) IfTitle Level Level Informationno check boxes are selected, then only the Level 1 TOC entries will be generated. (See the examModifying Titles, Styles, and Fontsple to learn how to modify Title and Level settings.)

Regulatory guidance recommends the use of no more than four heading levels in the TOC and bookmarkhierarchy.

To hyperlink each TOC entry, select the check box.Create Links

Click the button to modify the hyperlink appearance. See the page for moreLink Properties Common Features details.

CBER requires hyperlink borders to be set to invisible with blue text. requires hyperlink borders to be set visible, blue, thin, and with black text.CDER

Select the numbering check box. Selecting this option applies the default leader character and page numbering optionsInsert Pagefor the TOC entries. See the section for more information.DetailsOptionally, enter a number in the field to determine the space between each TOC entry.Line Space

Line Space value must be between 0.01 and 1.0.

The Next step is to select where the TOC Page will be inserted in the open PDF or if it should be saved as a new PDF file. In theTOC Page Location group box there are two options:

Insert – Select this radio button and then select an option from the adjacent drop-down list. For example, select fromFirstthe drop-down list to insert the TOC as the first page of the open document. See the sections for more informationDetailson other options available in this drop-down list.

The radio button will be disabled when the Multiple documents radio button is selected.Insert

New Document – Select this radio button to save the TOC as a new PDF file. Click on the adjacent ellipsis ( ) button to…select a folder location where the PDF file will be saved and to provide a name for the PDF file.

This option is enabled for either or options.Current document Multiple documents

This option can be very useful to generate a cumulative TOC. For example, if a study report was authoredin eCTD granularity, a cumulative TOC can be generated so that the each file can be accessed from asingle TOC. This helps to save time and makes the review process more efficient.

Click the button to create the TOC.Generate TOC

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Example of a TOC Based on the Bookmarks in the Open PDF

Modifying Titles, Styles, and Fonts

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In the following examples, the TOC Builder – Level Information dialog box is accessed and used to select the TOC title, alignment, and fontsettings. It also is used to select the TOC level indent and font settings.

The options and settings selected in the dialog box will be remembered when this dialog box is closed. When reopening thedialog box for use on other documents, ensure that the options and settings are reviewed and set appropriately prior tocreating a new TOC.

Setting the TOC Title Information

Click on the button to open the TOC Builder – Level Information dialog box.Level Information

TOC Builder - Level Information Dialog Box, Title Information Group Box

Enter a title for the Table of Contents in the field. By default the TOC title is .Text Table of ContentsSelect the desired alignment options for the TOC title by clicking on the , , or button. If appropriate,Align Left Center Align Rightenter a number between in the text field. This number will set the space between the TOC title and the0.1 and 3.0 Lower Spacefirst TOC entry.Optionally, select the check box and select a color from the adjacent color drop-down list. This will be the backgroundBackground

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color for the TOC title.

Typically, a background color is not applied to the TOC title because it is not required by regulatory agencies.

Select a , , and from their respective drop-downs for the TOC Title.Font Size Color

For narrative text (including TOCs), Arial or Times New Roman font and 11 or 12 point size is recommended byregulatory guidance.

If changes need to be made to the TOC Levels, continue with the example. If not, then click theSetting the TOC Level Information button. These modified settings will be applied to the TOC title.OK

Setting the TOC Level Information

Open the TOC – Level Information dialog box, if not already open.

TOC Builder - Level Information Dialog Box, Level Information Group Box

Select a level (eg, Level 1) from the drop-down list. In this example, Level 1 is selected indicating that all selectionsSelect Levelmade in the Level Information group box will be applied to the first level in the new TOC.Select a , , and from their respective drop-down lists for the selected TOC Level.Font Size ColorOptionally, click the button to have all levels inherit the settings applied to the selected level. For example, ifApply to all levelsLevel 1 is selected, Levels 2 - 4 will inherit the font, size, color and indentation settings of Level 1 in the new TOC.

The option will be disabled for Level 1. The Indent option is enabled for the remaining levels to specify howIndentfar the selected level will be indented from Level 1.

Settings can be modified for each TOC level. Select another level (eg, Level 2) from the drop-down list and repeat stepsSelect level3 - 4 as needed. When finished selecting the level options, click the button. These modified settings will be applied to the appropriate TOC Levels.OK

Details

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TOC Builder Dialog Box

Multiple Documents, Select Documents

Select the radio button to enable the button. Click on the this button to open the TOC Builder –Multiple Document Select Documents...Select document dialog box and then select the documents for which a TOC will be created. TOC creation will be based on the file order inthe list box. Use the Arrows to change the order. See the page for information on Arrows, Add Files, Remove, andCommon FeaturesRemove All buttons. Optionally, a separator can be selected to indicate where each file's TOC begins.

TOC Builder - Select Documents Dialog Box

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To insert a separator into the TOC PDF file, select an option from the drop-down list.Separator

The options in the Separator drop-down list are:

File name – Select this option to use each file name as the separator for each TOC.Full Path Name – Select this option to use each file folder path (where the files are saved) as the separator for each TOC.Hyphen – Select this option to use a string of hyphens to separate each TOC.Line Space – Select this option to use a pre-defined distance (white space) between each TOC.

When creating a TOC for multiple documents, only the radio button will be enabled. This meansNew Documentthat the TOC will be saved as its own document (a separate PDF file).

From Item

When multiple documents are selected, the list will display the following options:From Item

Bookmarks – Select this option to use the document bookmarks to create the TOC entries.Title – Select this option to add the document title(s) (stored in the Adobe Acrobat’s Document Properties dialog box) to create theTOC entries.Author – Select this option to use the document author(s) to create the TOC entries.Subject – Select this option to use the document subject(s) to create the TOC entries.File Name – Select this option to use the document full file path(s) (where each file is saved) to create the TOC entries.

The , , and option are fields in the Adobe Acrobat Document Properties dialog box. If one ofTitle Author Subjectthese options is selected, then the values will be pulled from the Document properties dialog box to create theTOC entries. To open the Document Properties dialog box in Adobe Acrobe, click the menu and select the File Pr

option.operties

From Style

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TOC Builder, TOC by Style

Use this option when the open or selected documents do not have bookmarks to create the TOC. This option provides the ability to createTOC entries based on selected font, selected area, entered keywords, or hyperlinks.

When this radio button is selected, the button will be enabled. Click this button to open the TOC Builder – TOC Styles dialogSet TOC Stylesbox. The options in this dialog box are identical to the options in the Bookmark Generator dialog box. The only difference is that options inthis dialog box are used only to create TOC headings. Using the options in this dialog box will not create bookmarks in the open or selectedPDF(s). See the tool for more details on these options.Bookmark Generator

Preview

Click this button to see how the TOC will look with the selected Title and Level settings (font, style, color and indentation). The Title and Levelsettings can be modified at anytime. See the section for more information.Modifying Titles, Styles, and Fonts

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TOC Builder - Preview Dialog Box

Page Justification

Select this check box to enable the button. Click the button to open the Page Justification dialog box. The options in thisSettings Settingsdialog box are used to position TOC hyperlink destinations. See the page for more information on these options.Common Features

Insert Page Number

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Select this check box to enable the adjacent button. Click the button to open the TOC Builder – Page Number dialog box.Settings Settings

TOC Builder - Page Number Dialog Box

The options in this dialog box are used to include the page numbers of each TOC entry. Additionally, leader character (such as dotted line[…….] or dash lines [------]) can be added between each TOC entry and its page number. To do so, select the Show at the Right End

box to enable the drop-down list and select an option. The selected option will be used as the leaderCheck Page Number Separatorcharacter.

The page number options are:

Use Absolute Page Numbers – Select this radio button to use the Adobe Acrobat page numbers as the page numbers for TOCentries. Selecting this option will override the page mapping information set up in the Page Mapper tool.Get Page Number from the Page Label Destination Page – Select this radio button to use the page labels that were created bythe Page Mapper tool. The page mapping and page labels must be created prior to selecting this option.Use a page map – Select this radio button to use the page mapping information set by the Page Mapper tool.

When the Multiple Documents radio button is selected, the Get Page Number from the Page Label Destination and options are disabled.Page Use a page map

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Fill Background Color

Select this check box and pick a color from the adjacent color drop-down list. This will be the color behind each TOC entry.

Typically, a background color is not applied to TOC entries because it is not a regulatory requirement.

Insert Section Number

Select this check box to automatically apply sequential section numbers to the TOC entries. The section numbers are inserted at thebeginning of each TOC entry in superscript format.

Set Page & Area

TOC Builder - Page Settings Dialog Box

The options in the group box display size and orientation of the open PDF document. Click the button to open the TOCSet Page & AreaBuilder – Page Setting dialog box, which is used to select the size, orientation and margins of the page.

Use Destination Editor

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Select this check box to review and modify TOC entries and destinations before the TOC is created. When selected, the buttGenerate TOCon will temporarily change into the button. Click the button to open the TOC Builder – Destination EditorView Destination View Destinationdialog box.

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TOC Builder - Destination Editor Dialog Box

Existing TOC entries and page destinations can be modified. Simply select an entry from the list box and make the necessary modification inthe Title and Page fields in the TOC Information group box. Click the button to apply the changes.Modify

New TOC entries can also be added to the TOC. Select an existing TOC entry from the list box. The entry selected should be either directlyabove or directly below where the new TOC entry should be added. If the new TOC entry needs to be a sub entry (a child entry), select theentry directly above where it should be added. Next, select the appropriate option from the group box and click on the Add New TOC Entry

button. The selected entry will be duplicated. Select the duplicated entry, enter a title, and set the appropriate hyperlink destination.AddClick the button to apply the changes.Modify

When finished, click on the button to start the TOC creation process.Generate TOC

Rotation Manager

Page Content:


Using Rotation ManagerDetails

Understanding PDF Page RotationDifferences between Screen View Rotation and Page RotationRotation Information

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ToolBox > Advanced > Rotation Manager

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Overview

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Use this tool to retrieve, display, and physically change the current page rotation of a PDF file. Understanding and changing page rotation isuseful when publishing image-based PDF files. See the section to learn about PDF rotations.Details

Rotation Manager Dialog Box

Example

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Using Rotation Manager

Access the tool.Rotation ManagerClick the button to select file(s) to be reviewed for page rotation information. The selected files will be displayed in the Add Files File

list box. (See the page for details on the Arrows, Add Files, Add Directory, Remove Files, and Sort Files(s) Common Featuresbuttons.)

If any of the selected file(s) are open, a confirmation message will display asking to close the open file beforeadding it to the list. Clicking the button on the confirmation message will close the file and the message.Yes

Select a file from the list box. Each page of the selected file is reviewed for rotation information, and the relevant fields in theFiles(s)Rotation Information group box will be enabled. For example, if the selected document contains one page rotated to 180 degreesand the remaining pages with a 0 degree rotation, then the Rotation 0 and Rotation 180 check boxes will be enabled. Eachdrop-down list will contain the page numbers for each page of the selected rotation. See the section for more information.DetailsIf the rotation of a page needs to be modified, select the appropriate rotation check box and select a specific page number (or All)from the drop down list. The drop-down list will be enabled.Page No. Rotation OptionsClick the button to preview the current orientation of the selected page.View PageTo change the rotation, select the appropriate option from the drop-down list. The options in this group box areRotation Optionsused to modify the rotation of the currently selected page(s). For example, if pages 2-6 in the selected document are set at a 90degree rotation and it is desired to rotate them clockwise as additional 90 degrees, then the optionRotation clockwise 90 degreescan be selected from the drop-down list. The available options are: , , Change to rotation 0 Rotate clockwise 90 degrees Rotate

, and and counterclockwise 90 degrees Rotate 180 degrees, Rotate automatically using OCR.Click the button. The rotation will be applied and the preview area will be updated.Change

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If the rotation change applies a rotation that was not found in the original file review, then the relevant field inRotation Information group box will be enabled.When selecting the option, the physical PDF page rotation based on OCRRotate automatically using OCRresults will be changed, and the page rotation tag will be set to Zero.

Repeat steps 4 – 7 to select an additional page or pages for rotation change.When finished, click the button to save the changes made to the selected file.Save Files

Details

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Understanding PDF Page Rotation

A PDF page rotation is based on 90 degree increments. The rotation degrees options are 0 degrees, Clockwise 90 degrees,Counterclockwise 90 degrees, and 180 degrees. The rotation information of each page is stored in tags. Tags are a special set of instructionsthat are used to identify each PDF page rotation. Tags are not visible on PDF pages; they are sorted in the PDF document information.

Examples of Portrait Document with Rotation Degrees

These rotations are used to set the page view (the display on screen) and determine how the page will be printed.

Differences between Screen View Rotation and Page Rotation

In Adobe Acrobat, the > > or options can be used to temporarily change the rotation of theView Rotate View Clockwise Counterclockwisepage screen view. This only changes the view of the page, not its actual rotation. The original page rotation is restored the next time the PDFfile is opened.

When the > option is used, the actual page rotation for all or specified pages in the open document can beDocument Rotate Pagespermanently changed. And because there are no options in the Acrobat Rotate Pages dialog box to indicate the current page orientation, itis difficult to make an accurate decision as to whether or not the page rotation should be changed.

In the below screenshot, the PDF page view was temporarily changed from 180 degrees to 0 degrees (using the View > Rotate View option)to demonstrate how easily page view rotation can be mistaken for the actual page rotation. Based this page view, unnecessary and incorrectrotation changes can be applied that can ultimately result in additional work.

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Example of a Temporarily Rotated Page View, Set at 0 Degrees

If the rotation view were changed to the view in the screen shot above and it was now assumed the page rotation is correct, then when aheader and footer are applied in a publishing application (such as ISIPublisher) the result would be improper placement on the pages (asshown in the screen shot below), causing rework to be required.

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Example of a Page Rotated at 180 Degrees with a Header and Footer Applied

Using Rotation Manager instead of the Adobe Acrobat Rotate Pages dialog box option can help to ensure that this task is performed properlythe first time. Rotation Manager provides both the current page rotation information and the ability to view each page to help determine if arotation change is necessary.

Rotation Information

The drop-down lists and check boxes in this group box are enabled when a selected file from the File(s) list box contains one or more pagesof that particular rotation. For example, if in the selected document pages 5-7 are set at a 90 degree rotation (clockwise or counterclockwise),the Rotation 90 check box will be enabled and pages 5,6, and 7 will appear in its drop-down list. The option is listed in each rotationAlldrop-down list to change the rotation of all pages instead of selecting each page individually.

Rotation Information Options

PDF Information

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Exporting PDF InformationDetails

Show full path in Detailed InformationDelimiterApplication

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ToolBox > Advanced > PDF Information

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Overview

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Use this tool to create a report that displays detailed information about one or multiple PDF files, such as the total number of bookmarks,hyperlinks, pages, etc. The information can be exported into a CSV or XLS file, which can be viewed in their respective applications. Theinformation in the exported file can be used to estimate and plan the time needed to review bookmark and hyperlink accuracy and otherqualify control processes.

PDF Information Dialog Box

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Example

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Exporting PDF Information

Access the tool.PDF InformationClick the button to navigate to and select a folder containing the files to be included in the report. Or, click the Add Directory Add

button to select files from different folders. (See the page for details on Add Files, Add Director, RemoveFiles Common FeaturesFiles, and Sort Files buttons.)Click the file ellipsis ( ) button to open the PDF Information -- Save File dialog box.Export …From the drop-down list, select the appropriate folder location where the file will be saved. Then provide a name for theSave in:export file in the *File name* field.If necessary, select the appropriate file type from the *Save as type* drop-down list. The options are: or CSV Files (.csv) Excel

. The default file type is Excel Files (.xls).Files (.xls)

If Excel Files(.xls) option is selected, the Delimiter and Application options will be disabled.

Click on the button to begin the reporting process. When the exporting process is completed, the tab will display theStart Resultsexported information.

PDF Information Dialog Box, Results TabOptionally, click on the button on the Results tab to open the exported file.Details

Details button is enabled after the exporting process is completed.

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Example of an Excel (*.xls) Exported File

When the exported file (Excel or CSV) is opened in Microsoft Excel, it will include a “Summary” sheet and aseparate worksheet for each file. Each worksheet is accessed by the tabs at the bottom of the open Excel file (asseen in the above screenshot). The “Summary” sheet will contain cumulative information from all files. To reviewthe PDF information of an individual file, click on its respective tab name. In most cases the file title will be used asthe sheet name. However, if the *Show full path in details Information* check box is selected (in the PDFInformation dialog box), a name name will be automatically assigned to each sheet based on the location of eachfile. See the Details section for more information on this option.

Details

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Show full path in Detailed Information

Select this check box to use each file’s folder path (where the file is saved) as the File Name in the exported file. (The file path will bedisplayed under the “File Name” column in the exported file.) If this option is not selected, then the file title of each document will used toreport the “File Name”.

Delimiter

Select an option (tab or comma) from this drop-down list to be used as the divider character to separate fields in the exported file.

Application

Click on the ellipsis ( ) button to open the PDF Information -- Browse Application dialog box. In this dialog box, navigate to andApplication …select an application that will be used to open the CSV file. Microsoft Excel is the default application that will be use to open CSV files.

Delimiter and options are only enabled when the CSV(*.csv) file type is selected in the PDF Information --ApplicationSave File dialog box.

eSubmission Tools

Page Content:

OverviewPharma-Specific Terms

ApplicationLifecycleSubmissionNeeS SubmissionSequence NumberMD5 CheckSum

Overview

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The eSubmission Tools only appear in the Pharma edition of ToolBox. They are used to assist pharmaceutical companies in preparing andreviewing submissions for regulatory approval. Many industry-specific terms are used in the eSubmission Tool descriptions, so please referto the list of terms below, when necessary.

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Pharma-Specific Terms

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Application

A collection of sequences provided to a health authority or regulatory agency to market or license a new product. An application is typicallythe first sequence of a submission. An Application can be considered a living dossier. Once it has been submitted and approved, allsubsequent submissions will update portions of this living dossier under the same application number.

Lifecycle

Two types of lifecycles are associated with an application:

Application Lifecycle -- Refers to the lifetime of an eCTD application, which includes all submissions created during that lifetimeand their associated sequence numbers. A new submission is created each time new, corrected or updated information is sent to aregulatory agency. Each submission is assigned a unique four digit sequence number. NeeS and paper submissions alsoincorporate application lifecycle concepts, however the information is communicated in the submission cover letter.Document Lifecycle -- As documents are added to a subsequent eCTD sequence, a lifecycle operation attribute is applied to eachdocument. The operation attributes are New, Appended, and Replaced. The operation attribute of Delete also can be applied todocuments that were previously submitted, but no longer are applicable to the submission.

New -- A new file that has no relationship to a previously submitted file.Append -- While the file is new to the dossier, the content adds new information to a previously submitted file.Replace -- The file is new to the dossier, however, the content supersedes the content of a previously submitted document.The previously submitted document’s content isno longer relevant. The original file is not removed.Delete -- The previously submitted document is no longer relevant to the dossier and new content is not necessary. (Thephysical file is not deleted, however.)

Submission

Each set of documents sent to a regulatory agency for review is called a submission. Any number of submissions can occur during thelifetime of an application.

NeeS Submission

A NeeS (Non-eCTD electronic Submission) is an electronic submission that is based on the CTD format, but the index.xml is replaced byTOCs in a PDF format. The TOCs required for a NeeS have specific requirements. The top level is the overall TOC, which contains ahyperlinked list of the submission module TOCs (M1-M5). Each module TOC contains a hyperlinked list of the submission documents withinit's corresponding module. For example, if module 2 contains a document titled "Clinical Overview", the module 2 TOC will display the entry"Clinical Overview" that links directly to the actual document. See the figure below.

Sequence Number

This is the unique four digit number assigned to each eCTD submission. A sequence number identifies a submission.

MD5 CheckSum

An MD5 checksum (Message-Digest Algorithm) is a unique 32-character hexadecimal string (eg, ”1a966d33c4a7c4440cc05312cc6c3517”)assigned to each file in an eCTD submission, as well as to the submission as a whole. Checksums are used to validate the integrity of aneCTD submission and each file within it. Final checksums are assigned to a submission prior to sending it to an agency, and are used by theagency to ensure that files have not been corrupted or changed during the transmission.

The hexadecimal string for each file is placed into the XML code as seen in the code example below.

Code Example:

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<m2-3-quality-overall-summary><m2-3-introduction>< checksum-type=”md5” operation=”new” xlink:href=”m2/23-qos/introduction.pdf”leaf checksum=”2daa9d6445454c81fcfc7c84bf11af75”ID=”ISI1217”><title>Introduction</title></leaf></m2-3-introduction><m2-3-s-drug-substance manufacturer=”braino tech” substance=”brainoxin”>< checksum-type=”md5” operation=”new”leaf checksum=”de2e47b7b94156f4222f86b2753b2c4d”xlink:href=”m2/23-qos/drug-substancebrainoxin.pdf” ID=”ISI1219”><title>Drug Substance Brainoxin</title></leaf></m2-3-s-drug-substance>

The string for the whole submission will be included as a separate text file and placed in the submission folder structure. See the figurebelow.

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Link LifeCycle Report

Page Content:


Running a LifeCycle ReportDetails

Status Column Messages Go to destinationExport report

CSV FileXML File

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Overview

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The Link LifeCycle Report tool is used exclusively for Japanese submissions with more than one sequence. Broken links are not accepted inJapanese submissions, but they often occur when a link’s destination file is replaced or deleted during eCTD lifecycle. And so it is importantto ensure that links pointing to and from updated documents are maintained when documents are lifecycled from sequence to sequence in aJP submission.

It is often difficult to locate broken links in an eCTD sequence, but this tool makes it easy by importing a selected Japanese eCTD sequence(index.xml) and displaying the broken links. If broken links are found in the selected sequence, the tool in ToolBoxBookmark & Link Auditor

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can be used to make the appropriate updates. Once the links and bookmarks are adjusted, the tool can be used toMD5 Checksum Checkerupdate the invalid checksums in the index.xml file.

Link LifeCycle Report Dialog Box

If more than one sequence (0001, 0002, etc.) does not exist in the selected Japanese submission, the index.xml will not beaccepted.

Examples

Running a LifeCycle Report

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Access the tool.Link LifeCycle ReportClick the button. The Open dialog box will appear, which is used to locate the desired JapaneseSelect Japanese sequencesequence file (index.xml).Select the desired index.xml file and click the button. The Open dialog box will close, the path for the selected JapaneseOpensequence will appear in the area box and the button will be enabled.Select Japanese Sequence Start auditClick the button. The scanning process will initiate and, once completed, the link information for the files in the selectedStart auditsequence will be displayed in the list box. A message will appear after the scan is completed providing theLink LifeCycle Reportnumber of links in the selected sequence.

Link Lifecycle Report Information MessageClick the button. The message will close and the link information will be displayed in the Link LifeCycle Report list box.OKSelect a link displaying in the Status column. This status means that either a source or destination file wasSource/Dest not currentlifecycled (appended or replaced), but the links continue to point to the outdated file. For instance, if source document A containslinks to destination document B and destination document B is replaced (lifecycled) by document C, the links in source document Apoint to the outdated document B.

For further information on source and destination document statuses, refer to the portiStatus Column Messageson of the Details section.

Click the button. The PDF document containing the source link will open. Using the Acrobat's search field, enterGo to sourcethe link title (found in the “Source Title” column) and search the PDF document to locate the link in the source PDF document.Correct the hyperlink using the appropriate ISIToolBox tool (ie, ).Bookmark & Link Auditor

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Viewing the Source DocumentIf necessary click the button to create a CSV or XML file of the Link LifeCycle Report. See details below.Report Export reportRepeat this process for each broken hyperlink.

Details

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Status Column Messages

The data in the Status column indicates if the destination is missing or if the Source and/or Destination files are not current.

Invalid link – This status displays when the destination document of the external hyperlink does not exist in the application. It is bestto view the source document to see the context of the hyperlink and to determine if the hyperlink should be removed, modified with acorrect destination, or if the destination file needs to be added to the submission.Source/Destination not current – This status displays when the hyperlink destination is not pointing to the most current document

and the source document is not in the selected sequence. The hyperlink destination would need to be updated to point to the mostcurrent file that replaced the previous file, and the source document would need to be incorporated into the selected sequence.Source/Destination not current, Destination page is missing - This status is the same as the previous status, with the additionthat the destination page does not exist. This can happen if pages were removed from the destination document and the hyperlinkdestination was not updated.

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Source is current/Destination is not current – This status displays when the hyperlink destination is not pointing to the mostcurrent document. The hyperlink destination would need to be updated to point to the most current file that replaced the previous file.OK – This status displays when both the source and destination documents are the most current for the selected sequence and thedestinations point to the most current documents.OK/Destination page is missing – This status is the same as the previous status, however the destination page does not exist inthe external destination document. This may have happened if pages were removed from the destination document and thehyperlink destination was not updated.Internal page missing – This status displays when the destination page for an internal hyperlink does not exist in the document. Forexample, the hyperlink’s target page is 10, yet the document contains only eight pages.

In the first segment of this diagram, in sequence 0002, is hyperlinked to a destination within . In sequence 0003, wasfile A file B file Breplaced. However, the hyperlink in still points to in sequence 0002. This is not acceptable.file A file B

In the second segment of this diagram, is added to sequence 0003, but the hyperlink destination still points to file B in sequence 0002.File AThis is not acceptable.

In the third segment, is added to sequence 0003, but the hyperlink source has also been modified to point to in sequence 0003.file A file BThis is proper and acceptable.

Go to destination

This button opens the selected link’s destination file. The destination file name appears in the Dest File column.

Export report

Clicking the button opens the dialog box, which is used to save the report as a CSV or XML file to any location.Export report Save As

CSV File

Exporting to CSV format creates an Excel spreadsheet containing the link information from the dialog box. TheLink LifeCycle Reportreport can be used for tracking and auditing purposes.

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Example of the Link LifeCycle Report CSV File

XML File

Exporting to XML format creates an XML file containing the link information from the dialog box. TheLink LifeCycle Reportexported link metadata can be utilized by XML applications.

Example of the Link LifeCycle Report XML File

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MD5 CheckSum Checker

Page Content:

OverviewExamples

Updating an Invalid ChecksumDetails

ReportCSV FileXML File

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ToolBox > eSubmission Tools > MD5 CheckSum Checker

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Overview

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eCTD Guidance requires an be generated for every file in the sequence being submitted, as well as for the overallMD5 checksumsubmission. The file checksums are recorded as part of the leaf information inside the index.xml file. The overall submission checksum issaved as a separate .txt file in the submission folder structure. File alterations (such as additional links and bookmarks, an inserted signaturepage, etc.) made after the index.xml is generated will cause the MD5 checksums to be invalid. This tool can be used as a way to check andupdate the MD5 checksums without having to go back to the larger eCTD compiling system (such as eCTDXPress) and recompile the entiresequence.

MD5 Checksum Checker Dialog Box

Examples

Updating an Invalid Checksum

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Access the tool.MD5 Checksum CheckerClick the next to the XML File field. The MD5 Checksum Checker – Load index File dialog box will open.ellipsis button

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Loading the index.xml File into the MD5 Checksum Checker Dialog BoxSelect the submission’s index.xml file.The path for the selected index.xml file will appear in the field, the documents associated with the selected index.xml willXML Filebe displayed in the list box, and the column for each submission document will display .Check Not Checked

The Check column displaying Not CheckedClick the button. An MD5 checksum will be generated for each listed file, and then it will be compared to theCheck Checksumexisting checksum. If the two do not match, the checksum is invalid. The Check column will display Invalid.Locate any document checksums in the column. If there are no invalid checksums, no further actions are necessary.Invalid Check

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Clicking on the column header sorts the checksum results (Valid or Invalid) alphabetically. This is a usefulCheckmethod for grouping all invalid checksums together.

If Invalid checksums are found, click the button to automatically change the MD5 checksum in the index.xml file.Update ChecksumA warning message will open stating that the xml and text files will be updated.

If / when invalid entries are found, it is recommended to review the files and understand the change that wasmade.

MD5 Checksum Checker Warning MessageClick the button. The xml and text files will be updated and an information message will appear.YesClick the button on the message.OKAll documents will now display in the column and checksums in the Checksum and Valid Checksum columns willValid Checkmatch.

Prior to updating the index.xml file, the tool will create back-ups of the old index.xml and index-md5.txt files andplace them in the submission folder location. These back-up files will be titled index.old and index-md5.old as seenin the image below. If the Invalid checksums were found in module 1, the regional XML file will also be updatedand a backup of the old file will be created as well.

The index.old and index-md5.old filesIf needed, click the button to generate a CSV or XML output of the information provided in this dialog box. See detailReport Reports below.

Details

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Report

MD5 Checksum Checker - Report Dialog Box

Only selected results: This radio button will create a report for submission documents selected using the Ctrl and/or Shift keys.All results: This radio button will create a report for the entire submission.Select a File: This group box is used to determine whether the report will be a csv or xml file.CSV: This radio button will create the report as a csv file.XML: This radio button will create the report as an xml file.File: Clicking the next to this field launches the MD5 Checksum Checker – Save as a CSV file or the MD5 Checksumellipsis buttonChecker – Save as an XML file dialog box, depending on which radio button is selected. These dialog boxes determine where thecsv or xml file will be stored.

CSV File

Exporting to csv format creates an Excel spreadsheet containing the validation information from the dialog box. MD5 Checksum CheckerThis report can be used for tracking and auditing purposes.

Example of the MD5 Checksum Checker Report CSV File

XML File

Exporting to xml format creates an xml file containing the information from the dialog box. The exported metadataMD5 Checksum Checkercan be utilized by xml applications.

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Example of the MD5 Checksum Checker XML File

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NeeS-ICH Verification Check

Page Content:


Verifying a Selected SubmissionDetails

NeeS/ICH Verification Check - OptionsReport

CSV FileXML File

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ToolBox > eSubmission Tools > NeeS/ICH Verification Check

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Overview

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This tool will ensure that a submission is ICH compliant by checking the ICH recommended naming conventions and PDF options applied tothe files, folders, and paths in a selected submission. If errors are found in the selected submission, please go back to your eCTD buildingtool, make the necessary updates, and recompile your submission.

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NeeS/ICH Verification Check Dialog Box

Examples

Verifying a Selected Submission

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Access the tool.NeeS/ICH Verification CheckTo customize the checks that are performed, click the button and select or enter the specific options. See below inOptions Optionsthe Details section for descriptions of each.

NeeS/ICH Verification Check - Options Dialog BoxClick the button. The Browse For Folder dialog box will open, which is used to locate and select the applicationSelect Applicationto be verified.

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Selecting an Application from the Browse For Folder Dialog BoxSelect the application in the Browse For Folder dialog box and click the button.OK

Notice that the application level is selected, not the individual sequence level. This is done so that the properapplication directory above the sequence level can be verified. It also allows for multiple sequences to bechecked simultaneously.

Click the button. The verification progress bar will appear and checks will be run on all sequences within the selectedVerifyapplication. Once the process is completed, the progress bar will close and the sequence information will display in the left panel ofthe dialog box.

To view a different sequence, click the sequence drop-down menu and select the appropriate choice.

In the left pane, the overall submission level folder appears at the very top, followed by the individual module level folders. Theinformation is broken down in the same manner for the overall and module folder levels (xml, TOC, the number of files, the numberof folders, the number of folders without files, the number of folders with files.)Click on a line (module level or below the module) in the left pane to display the verification results in the right pane. For example, ifa module is selected, then results for all elements within that module (files and folders) will be included in the right pane.When a green check is displayed, it is an indication that the file or folder has passed the verification check specified in the columnheading. For instance, if the Path Length for the file or folder does not exceed the maximum number of characters defined byNeeS/ICH guidelines, a green check will appear in the Path Length column.When a red x is displayed, it is an indication that the file or folder has failed the verification check specified in the columnheading. For instance, if a file or folder name contains an underscore, a red x will appear in the Underscores column because fileand folder names with underscores are not in accordance with NeeS/ICH guidelines.

File and folder names appearing in red text in the Name column is an indication that the file or folder has failed oneor more of the NeeS/ICH verification checks. If failures occur, please go back to the eCTD output and make theproper adjustments.

If necessary, click the button to create a CSV or XML file of the NeeS/ICH Verification Check Report. See DetailsReport Report

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Details

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NeeS/ICH Verification Check - Options

NeeS/ICH Verification Check - Options Dialog Box

Check for spaces in file path: Select this option to check for spaces in al file paths.Check for underscores in file path: Select this option to check for underscores in all file paths.Check for uppercase characters in file path: Select this option to ensure that uppercase characters do not exist in the file path.Check for multiple dashes in file path: Select this option to ensure that multiple dashes do not exist in the file names. Anexception is made for this option to accomodate for Study ID file naming convention used in eCTDXPress to automatically createstudy tagging files. This can exist in the index.xml, but not in the file names for a NeeS.Check for invalid characters in file path: Select this option to ensure that invalid characters do not exist in the file path.Maximum length of a file path: This field is used to enter the maximum length of the file path. If the file path length exceeds thenumber entered in this field it will not pass the verification.Maximum length of a file name: This field is used to enter the maximum length of the file name. If the file name length exceeds thenumber entered in this field it will not pass the verification.Maximum length of a folder name: This field is used to enter the maximum length of the folder name. If the folder name lengthexceeds the number entered in this field it will not pass the verification.Regular Expressions Option: This group box is used to add or load custom validation checks.Add: Click this button to add the regular expression string to the list box.Modify: Click this button to modify a selected regular expression string.Delete: Click this button to delete a selected regular expression string.Load: Click this button to load an LST file containing regular expression strings.Save: Click this button to open the NeeS/ICH Verification Check – Save Regular Expressions File dialog box, which is used to savethe regular expression strings in the list box to an LST file that can be imported back at any time.PDF Options: This group box is used to verify that specific options have been applied to PDF documents in the selectedsubmission.Check for PDF document restrictions: Select this check box to verify that all PDF documents in the selected submission containdocument restrictions, such as password protection.Check for PDF format version: Select this check box to verify that all PDF documents in the selected submission match theversion number selected from the drop-down menu.Check for absolute path: Select this check box to check for any absolute paths in bookmarks and hyperlinks. All bookmarks andhyperlinks should have a relative path.Check for backslash in the path: Select this check box to verify that the link path contains a backslash.

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Check for Javascript opening external documents: Select this check box to verify that the submission file contains any link orbookmark with a Javascript action of opening external document.Check for destination of NeeS TOC item: Select this check box to verify that all hyperlinked entries in the NeeS TOC havedestinations.Check if file size is bigger than ...Size: Select this check box to verify that a file is over the specified size. Enter the specified sizein the adjacent text field and select either, KB or MB from the drop-down list.

Report

Clicking the button opens the dialog box, which is used to save the report as a CSV or XML file to any location.Report Save As

Saving the Nees/ICH Verification Check Report

CSV File

Exporting to CSV format creates an Excel spreadsheet containing the link information from the dialog box. TheLink LifeCycle Reportreport can be used for tracking and auditing purposes.

Example of the NeeS/ICH Verification Check Report CSV File

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XML File

Exporting to XML format creates an XML file containing the link information from the dialog box. TheNeeS/ICH Verification Checkexported metadata can be utilized by XML applications.

Example of the NeeS/ICH Verification Check Report XML File

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NeeS TOC Builder

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Page Content:


Generating Overall and Module TOCsModifying Titles, Styles and Fonts

Modifying the Overall TOC OptionsModifying the Module TOC Options

Add/Modify TOC EntriesDetails

NeeS TOC Building Dialog Box DetailsIndex XML

Sequence FolderRegion & VersionSave to other directoryModule PreviewSet Page & AreaExportImportItem Editor

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ToolBox > eSubmission Tools > NeeS TOC Builder

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Nees TOC Builder

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Overview

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The NeeS TOC Builder is used to generate an overall TOC and module TOCs from either a selected index.xml file or a sequence folder. Thegenerated TOCs will be compliant with Non-electronic eCTD Submission (NeeS) regulatory requirements.

A NeeS submission requires that the overall TOC contains hyperlinked entries to only the individual modules. The module TOCs are requiredto have links to only the documents within that module. One module TOC is required for each module within the sequence.

As recommended within the NeeS guidance, auto-return Bookmarks can be added to each Module TOC for an easy return to the overallTOC and to all submission documents for an easy return back to the appropriate module TOC.

The overall and module TOCs can be saved to the source directory (where the submission currently exists) or they can be saved to adifferent directory.

If the TOCs are saved to a different directory, the entire submission (all folders and files) is copied to the selected location. If auto-returnbookmarks were added, they will be placed in only the copied files.

If the TOCs are saved to the source directory, the TOCs are physically placed in the source directory. If auto-return bookmarks were added,they will be placed in each source file in the submission. Adding auto-return bookmarks to the source files will invalidate all MD5 checksums.If this is not the intended result, it is recommended to save the TOCs to another directory.

When using the NeeS TOC Builder to create overall and module TOCs, the font styles and sizes used can be customized.

NeeS TOC Builder Dialog Box

Examples

Generating Overall and Module TOCs

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Access the tool.NeeS TOC Builder

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Select the radio button and click the adjacent button to select a submission’s file. The NeeS TOCIndex XML ellipsis index.xmlBuilder – Select an index.xml dialog box will close and the selected index.xml file will be displayed in the Index XML field.

For further information on the index.xml and sequence folder options, please refer to the section of thisDetailspage

Select the Save to other directory check box and click the adjacent button. The Browse For Folder dialog box will open soellipsisthat an output location for the generated overall TOC, module TOCs, and submission content can be selected.

Overall and module TOCs can be saved to the source directory or to a different directory. If saved to a differentdirectory, the entire submission (all folders and files) is copied to the selected location. If saved to the sourcedirectory, the NeeS TOCs are physically placed in the source directory and the links in the TOCs point to thesource submission. When the NeeS TOCs are saved to the source directory, links and bookmarks are added tothe source files, rendering all MD5 checksums invalid. If this is not the intended result, it is recommended to savethe TOCs to another directory.

Select the check box in the Options group box. This will hyperlink the entries in the overall and module TOCs. ClickCreate Linksthe button to select the appearance and action for the hyperlinks in the overall TOC and module TOCs. (See theLink PropertiesCommon Features page for Link Properties details.) The Link Text Color drop-down menu can be used to modify the hyperlink color.Select the check box. This will add a return bookmark in the module TOCs with a destination to the overallAuto-return BookmarkTOC, and return bookmarks in the submission documents with a destination to the module TOCs (as shown in the images below).

Example of a Module TOC with a Return Bookmark to the Overall TOC and an Example of a Submission Document with a ReturnBookmark to the Corresponding Module TOC

Regional/ICH metadata specified as attributes will be included in backbone xml files. This will allow TOC entries forfolder nodes when generating TOC.

Click the button next to the Auto-return Bookmark check box to enter the text to be used as titles for the Auto-returnSettingbookmarks. This will open the NeeS TOC Builder – Bookmark Options dialog box.

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Entering the Text for the Overall and Module TOC BookmarksSelect the check box to add a bookmark to the module TOCs that links back to theCreate a bookmark pointing to overall TOCoverall TOC. This will automatically add a bookmark to the module TOCs that links back to the overall TOC. ICH guidance statesthat in a NeeS "An additional function might be provided to allow easy navigation back to the table of contents above. This can beachieved through the use of a bookmark linked back to the previous level. This additional function isn’t mandatory but when providedit will facilitate the assessment." Enter the bookmark text in the field below. This will be the text used for the bookmark in the module TOC that links back to theoverall TOC. For example, if "Overall TOC" is entered in the field (as shown in the image above), an auto-return bookmark calledOverall TOC will be added to each module TOC.Select the check box to add a bookmark to submission documents that links back toCreate a bookmark pointing to module TOCthe associated module TOC. For example, all module 2 documents will contain an auto-return link that jumps back to the module 2TOC.Enter the bookmark text in the field below. This will be the text used for the bookmark that links back to the module TOC. Forexample, if "Module TOC" is entered in the field, as shown in the image above, an auto-return bookmark called Module TOC will beadded to each submission document.Select the check box to add an additional level 1 bookmark to segregate theCreate a root bookmark of existing bookmarksauto-return bookmark from bookmarks already existing in the document. The additional level 1 bookmark will take on the name ofthe document. The image below shows an added level 1 bookmark.

Example of An Added Level 1 Root Bookmark to a DocumentClick the button. The NeeS TOC Builder – Bookmark Options dialog box will close and the auto-return bookmark options will beOKset.Select the check box then click the adjacent button to specifiy where to place the non-PDF files.Remove Non-PDF Files Setting

ICH guidance prohibits the existence of non-PDF file formats within a Nees. Non-PDF submission files, such asdata sets (SAS), should be submitted to regulatory agencies in a separate folder. Selecting the Remove Non-PDFFile option will transfer non-PDF documents to a separate folder that can be submitted to a regulatoryagency along with the NeeS. If this option is not selected, all non-PDF documents will be included in thegenerated NeeS output.

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Setting the Non-PDF File OptionsClick the button next to Save Non-PDF Files field to select a storage location for the removed non-PDF files.ellipsisSelect the radio button. If a document with the same file name already exists in the selectedIncrease the file index numberstorage location and this radio button is selected, a number will be applied to the file name so that the document with the same filename is not overwritten, as seen in the image below.

Example of a Number Added to a Non-PDF File Name Already in the Storage LocationClick the button to close the Remove Non-PDF Files – Setting dialog box and save the settings.OKClick the buttonto open the NeeS TOC Builder – Page Setting dialog box and select the paper size, orientation,Set Page & Areaand the margins (Left, Right, Top, and Bottom) for the overall and module TOCs.Click the button to close the NeeS TOC Builder – Page Setting dialog box.OKClick the button. The NeeS TOC Builder – Item Editor dialog box will open.Load TOC Editor

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20. Generating the overall and module TOCsSelect from the drop-down list and click the button. The overall and module TOCs will be created andBoth Create Generate TOCstored with the submission documents in the location selected in the Save to other directory field. By default, the overall TOC isnamed ctd-toc and the modules are named m1-toc, m2-toc, and so on.

Examples of the Generated Overall and Module TOCs

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Modifications can be made to the TOC entries using the Item Editor dialog box, please see the Add/Modify TOCEntries process example below.

Titles, styles, and fonts can be modified using the TOC Information dialog box, please see the Modifying Titles,Styles and Fonts process example below.

Modifying Titles, Styles and Fonts

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Modifying the Overall TOC Options

Click the button. The NeeS TOC Builder – TOC Option dialog box will open.TOC Information

The TOC Option Dialog BoxEnter the title for the overall TOC in the field (located under the Overall TOC Options section of the dialog box). When theTitleoverall TOC is generated, this title will be placed at the top of the page as shown in the screen shot below.

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Example of the TOC title in the Overall TOCClick the button next to the field. The NeeS TOC Builder – Font Option dialog box will open so that the font type,Edit Title Fontsize, style and color can be selected for the overall TOC title.Click the button after selecting the font options. The NeeS TOC Builder – Font Option dialog box will close.OKSelect a module (M1-M5) from the drop-down list in the Overall TOC Options group box. The field next to the Item drop-downItemlist will display the title for the selected module that will appear in the generated overall TOC, as shown in the image below. Themodule titles can be edited in this field. Repeat this to view and edit each module that is contained in the submission.

Regardless of the number of modules within the selected index.xml or sequence folder, modules 1-5 will always bedisplayed in the Item drop-down menu. For instance, if the selected index.xml only contains modules 1 and 3, onlythe M1 and M3 titles need to be viewed or edited, since these will be the only modules appearing in the overallTOC.

Example of the Module Titles within the Overall TOCClick the button next to the field. The NeeS TOC Builder – Font Option dialog box will open so that the font type,Edit Item Fontsize, style, and color can be selected for the overall TOC module entries.Click the button after selecting the font options. The NeeS TOC Builder – Font Option dialog box will close. OK

Modifying the Module TOC Options

Select the desired module (M1-M5) from the drop-down list in the Module TOC Options group box. The field next to the TitleTitledrop-down menu will display the title for the selected module TOC, which will appear in the generated module TOC, as shown in theimage below. The title can be edited as needed. This process can be repeated to edit each module TOC title.

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Regardless of the number of modules within the selected index.xml or sequence folder, modules 1-5 will always bedisplayed in the Title drop-down list. For instance, if the selected index.xml only contains modules 1 and 3, onlythe M1 and M3 titles need to be viewed or edited, since these will be the only modules TOCs generated.

Example of Title for the Module 1 TOCClick the button next to the field. The NeeS TOC Builder – Font Option dialog box will open so that the font type,Edit Title Fontsize, style, and color can be selected for the module TOC titles.Click the button after selecting the font options. The NeeS TOC Builder – Font Option dialog box will close.OKSelect from the drop-down list in the group box. Select the appropriate options to define the appearance for1 Level Level Optionsthe Level 1 entries in the generated module TOCs. If 2 were selected from the Level drop-down list, the selected options would setthe appearance of the level 2 entries and so on. This process can be repeated for each module TOC. The image displays 4 TOCentry levels in a generated module TOC. If appropriate, click the button to assign the same settings for theApply to all lower levelsselected level to all lower levels (eg, if Level 2 were selected, it would not affect level 1.)

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Example of the Selected Level Options Applied to a Module TOCClick the button. The NeeS TOC Builder – TOC Option dialog box will close.OK

Add/Modify TOC Entries

This example shows how a new module TOC entry can be added in the NeeS TOC Builder – Item Editor dialog box.

Click the button. The NeeS TOC Builder – Item Editor dialog box will open.Load TOC EditorSelect the TOC for the desired module (M1-M5) from the drop-down list. The left side of the dialog box will display the TOCModuleentries for the selected module.

Only the modules that exist in the selected index.xml or sequence folder will appear in the in the Moduledrop-down list. For instance, if the selected index.xml only contains modules 1 and 3, only 1 and 3 will be availablein the Module drop-down list.

Select a TOC entry from the module TOC entry window. The selected TOC entry’s action, destination and title will be displayed inthe TOC Information group box.Enter a new name in the Title field.Select an action to apply to the new TOC entry. For instance, if Goto View External is selected, the new entry will link to an externaldocument once the TOC is generated.

If the Goto View External or Open File action is selected a destination file must be selected by clicking the bellipsisutton in the Destination field.

Select the radio button in the Add new TOC entry group box. This will insert the TOC entry just entered in the Title field afterAfterthe TOC entry selected in the module TOC entry view window.Click the button. The new TOC entry will be added to the currently displayed module TOC in the module TOC entry window.Add

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Adding a New Entry to a Module TOC

An existing module TOC entry can be modified by clicking on it in the module TOC entry window and altering itsvalues in the TOC Information fields.

Details

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NeeS TOC Building Dialog Box Details

Index XML

Select this radio button and click the button to launch the NeeS TOC Builder -- Select an index.xml dialog box. This dialog box is usedellipsisto select the index.xml file that will be used to create the NeeS TOCs. The content in the folder structure where the index.xml file is locatedwill be copied to the location specified in the *Save to other directory* field to create the NeeS submission. If another location is not specifiedthe source location will be used as the output location. If the source location is used as the output location, the submission in the selectedsource location will have the overall TOC and module TOCs added to it.

If the source folder is used as the output location, links will be added to the submission documents linking to theappropriate module TOC. This will compromise the MD5 checksums. However, can be used toMD5 CheckSum Checkerfix all modified checksums.

Sequence Folder

Select this radio button and click the button to launch the Browse For Folder dialog box. The Browse For Folder dialog box is used toellipsisselect the sequence folder (0000, 0001, 0002, etc.) that will be used to create the NeeS TOCs.

When the NeeS TOCs are created using a sequence folder, they are created based on templates that have been installed with ISIToolBox.There is one Module 1 template for each region and DTD version and an ICH template for modules 2-5. The Module 1 region andDTD version that matches the region and DTD of the selected sequence folder should be selected from the drop-down lists (located belowthe Sequence Folder field). If the matching region and DTD is not selected, the correct template will not be used and the Module 1 TOCcannot be viewed in the Item Editor dialog box and will not be generated..

If the NeeS TOCs are created using a Sequence Folder, there may be entries in the Item Editor dialog box that appear in red. This indicatesthere is a mismatch between the template (that contains the recommended regional and ICH naming conventions) and the files names foundin the sequence folder. This does not mean that errors exist or adjustments are necessary, however, it is advised to review these items. For

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example, study file names will typically be in red since the naming is specific to the study itself.

Region & Version

These drop-down lists are enabled when the Sequence Folder radio button is selected. The region and corresponding version that isselected should match the region and DTD version of the selected sequence folder. The selection of region and DTD version indicates thetemplate that will be used to verify the entries in the created NeeS TOCs. Some of the DTDs that are available are AU, CA, and GC.

The AU 0.00.02 DTD is still in its draft phase. Therefore, when it is the selected region in the Nees TOC dialog box, theword draft is stampled next to the list boxes.

The Gulf Countries DTDs that are supported by ToolBox 6.3 are: United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate ofOman, Saudia Arabia and Republic of Yemen.

Nees TOC Builder, GC 1.2

Save to other directory

Select this check box and click the button to launch the Browse For Folder dialog box. The Browse For Folder dialog box is used toellipsisselect an output folder location for the TOCs and the submission files. If this check box is not selected, the output will be placed in the samelocation as the source index.xml/sequence folder and the warning message shown below will appear.

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NeeS TOC Builder \- Warning Dialog Box

Using the Save to other directory option is the recommended approach, because when NeeS TOCs are added to thesource directory, links and bookmarks are added to the submission files, which makes all MD5 checksums invalid.

Module Preview

Click this button to open the NeeS TOC Builder -- Preview dialog box, which is used to view font options applied to the module TOC levels inthe NeeS TOC Builder -- TOC Options dialog box.

NeeS TOC Builder \- Preview Dialog Box

Set Page & Area

Click this button to launch the NeeS TOC Builder -- Page Setting dialog box, which is used to select the paper size, orientation, and marginsfor the overall TOC and Module TOCs.

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NeeS TOC Builder - Page Setting Dialog Box

Export

Click this button to launch the NeeS TOC Builder -- Export dialog box, which is used to save the settings for the overall TOC and moduleTOCs as an Excel file. The Excel file can be saved to a location of choice and then used to create NeeS TOCs for other submissions usingthe Import option.

Import

Click this button to launch the Open dialog box, which is used to import a previously saved Excel file that contains the settings for the overallTOC and module TOCs.

Item Editor

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NeeS TOC Builder - Item Editor Dialog Box

This dialog displays when the button is click on the NeeS TOC Builder dialog box. It is used to review the TOCs prior toLoad TOC Editorgenerator the output. The functions in this dialog box can be used to make modifications when necessary.

As mentioned in the Sequence Folder description above, there may be entries in the Item Editor that are in red. This is anindication there is a mismatch between what was found in the sequence folder and the selected template (selected fromthe Region and Version drop-down lists).

Expand all: Click this button to expand the module structure in the view window of this dialog box.Collapse all: Click this button to collapse the module structure in the view window of this dialog box.Modify: Click this button to initiate modifications made in the Title field. The title for the selected TOC entry will be altered in theview window when this button is clicked.Delete: Click this button to delete the selected TOC entry from the module structure.Title: The Title field in the TOC Information group box is used to enter the new TOC entry name.After: Select this radio button to place the new TOC entry after the currently selected TOC entry in the module structure viewwindow.Before: Select this radio button to place the new TOC entry before the currently selected TOC entry in the module structure viewwindow.Sub-section: Select this radio button to place the new TOC entry as a sub-section of the currently selected TOC entry in the modulestructure view window.Create: Select the option from this drop-down menu to indicate if an overall TOC or the module TOCs, or both will be generated.

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Batch

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Page Content:


Setting Up Batch FunctionsBatch (perform all functions at once)

Batch Status MessagesBatch OptionWorkflow (perform all functions step by step)

Workflow Status MessagesWorkflow OptionsDetails

Set Functions TabLoad Batch Button, Save Batch Button

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ToolBox > Batch

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Overview

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Use the Batch tool to perform one or more tasks across multiple files in a single process rather than working with each individual tool. Lists oftools and their settings can be saved and reused for further efficiency. Because tool parameters need only be specified once, the Batch toolis frequently used to ensure that all documents are processed identically. Processes can be run in a specific order and by selecting theWorkflow option, fuctions can be skipped or changes as needed for a specific file in the batch.

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Batch Dialog Box

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The following tools can be used in Batch mode:

Bookmark AttributerBookmark GeneratorDelete Bookmarks & LinksExpand BookmarksExport DocInfo*Export/ImportFont ManagerHidden Text ManageriDestinationiEnhanceImport DocInfo*Inter Document LinkerJavaScript*Keywork LinkerLink AttributerMaskMerge PDFPage MapperPage StamperScale PDFSearch & Replace TextShrink BookmarksSwap BookmarksTOC Builder

*These tools relate to Adobe Acrobat functions. The Export DocInfo and Import DocInfo options relate to the informationwithin the Document Properties (File > Document Properties). The JavaScript option allows for actions to be added tomultiple documents and relates to the JavaScript option under the Advanced menu in Acrobat.

In Batch function, some of the features within these tools are diasbled.

If Merge PDF Tool is used in Batch, it will be the last function performed.

Examples

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Setting Up Batch Functions

These steps need to be performed whether using the Batch or Workflow option.

Without opening the PDF files to be worked, access the tool. BatchClick either the or icon in the upper left corner. (see the page for details on theseAdd Files Add Directory Common Features buttons along with , , , and buttons, and the arrow buttons).Remove icon Sort Files Load List Save List

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Batch Dialog Box, Select FilesNavigate to and select the proper files or directory. The files will be listed in the top portion of the dialog box. IfBatch - Select Filesnecessary, use the arrow buttons to rearrange the files in the order needed or click the button to arrange the files inSort Filesalphabetic order. When done, click the button.OKClick the button to select the tools be used in Batch mode and to select the appropriate options for each.Set Functions

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Batch Dialog Box, Set FunctionsSelect one or more tools in the column and then click the right-facing double-arrow to move them to the Available Functions Select

column. To select more than one tool, hold down the key while making selections. If necessary, use the arrow buttons at theed Ctrlbottom of the dialog box to rearrange the order of the tools. The order of the tools should be the order in which the functions aredesired to perform on the selection of documents. Select one of the listed tools and click the button. The dialog box associated with that tool will be displayed. See eachPropertiesindividual tool's help page (see the hyperlinks above) for a description of the available options. For tools with no associated dialogbox, such as Shrink Bookmarks, a message will display to communicate that there are no selections necessary for that tool. Whendone, click the button. OKSelect either the or option. See the Details section below for an explanation of Batch vs Workflow.Batch WorkflowClick the button. The selected functions will be applied to all selected files. Refer to the Batch option and Workflow optionStartsections to see more about the processes.

Batch (perform all functions at once)

Batch Status Messages

When using the Batch option, the following messages will display to communicate the status of each process.

When the Batch process begins, the status message will be displayed."Batch started at [current date and time]"When the Batch process is successful, the status message will be"Batch ended successfully at [current date and time]"displayed.When the Batch process has failed, the status message will be displayed."Batch failed at [current date and time]"When the Batch process has been cancelled, the status message will be"Batch has been cancelled at [current date and time]"displayed .

Batch Option

When setting up the Batch function, click to choose files to which the Batch functions will be applied. Then click Select Files Set to choose specific functions that the Batch feature will apply to the selected files.Functions

Select the radio button.Batch

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Click the button. The Batch progress dialog box will be displayed. Once completed the success or failure message will beStartdisplayed.If Font Manager was one of the selected functions, the dialog box will be displayed. Either type inFont Manager - Batch Settingsthe and or click the (...) button to select a location and name the file. Then click the button.output path File Name ellipses ExportA message will dsplay indicating the information was exported successfully.

Font Manager,Batch Settings

Font Manager Message

Click on the message, then click on the Font Manager dialog box. The output of the exported font file will be in PDFOK Closeformat and contain the Font File Name. The selected font information of each file will be present on its respective sheet.

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Font File.xlsThe status dialog box will be displayed. Each function that was selected will be processed and the status of each will beBatchdisplayed.

Workflow (perform all functions step by step)

While Batch automatically processes documents and tools, Workflow opens the first file and the first tool, and provides the opportunity toeither skip the function for that specific file or make modifications to the functions settings to be applied to that specific file. Once completed,the button can be click to move to the next tool to be run on the same document. Next

Workflow Status Messages

When using the Workflow option, the following messages will display to communicate the status of each process.

When the Workflow process begins, the staus message will be displayed."[Function Name] is started"When the Workflow process is successful, the status message will be displayed."[Function Name] is ended successfully"When the Workflow process has failed, the status message will be displayed."[Function Name] has failed"When the Workflow process has been cancelled, the status message will be displayed."[Function Name] has been cancelled"When the Workflow process has saved, the status message will be displayed."[Function Name] has been saved"When the Workflow process has been completed, the status message will be displayed."[Function Name] has been completed"

Workflow Options

When setting up the Batch function, click to choose files to which the Batch function will be applied. Then click Select Files Set to choose specific functions that Batch feature will apply to the selected files.Functions

Select the radio button.WorkflowClick the button. The first PDF file will open. In this example, the first function selected to run is Font Manager, therefore the Start Fo

dialog box will open.nt Manager - Batch SettingsEither type in the and or click the (...) button to select a location and name the file. Then, click the output path File Name ellipses E

button. A message will display indicating the information was exported successfully.xport

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Batch, Workflow Process PDF file with Font Manager, Batch Settings Dialog Box

Batch, Workflow Font Manager Message Dialog BoxClick on the message, then click on the Font Manager dialog box. The output of the Font File Name.xls file will display asOK Closeshown in image below.

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6. Output FileThe dialog box will be displayed showing the process has ended successfully as shown in the image below.Batch

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Batch, Workflow Process Dialog BoxClick the button. The next function in the list will be initiated. In this example it is the function.Next Step Search & ReplacePerform the Search & Replace function as needed. If this function was not needed to be performed on the active file, it can becancelled.The dialog box will be displayed showing the Search & Replace process has ended successfully as shown in the imageBatchbelow. If the function was cancelled, the status message would be "Process: Search & Replace has been cancelled."

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Batch,Workflow Dialog Box Showing Process

Click the button. If Merge PDF is the next function in the list, a message will be displayed indicating that function willNext Stepbe executed once all other listed functions have bee applied (or cancelled) for all files.Continue clicking the button to apply each function to the file, and once all functions have been applied, to move to theNext Stepnext document.If Merge PDF was applied to the files, the output PDF will be opened along with the dialog box indicating the WorkflowBatchprocess has ended successfully.

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Batch, Workflow Process Completed

Details

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Set Functions Tab

Load Batch Button, Save Batch Button

These buttons work similarly to the and buttons. Once the functions and the appropriate settings have been selected,Load List Save Listthey can be saved as an Excel or CSV file. Then, the saved file can be loaded and used on a different batch of files.

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Help & Setting ToolsUse these options to set up preferences for ToolBox tools and the toolbar.

Included in this section are:

iBookmark PreferencesISICopy PreferencesToolBox PreferencesCustomizing the Toolbar


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iBookmark Preferences

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AccessOverviewDetails

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ToolBox > Help & Settings Tools > iBookmark Preferences

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Overview

The iBookmark tool is used to manually create individual bookmarks. Use iBookmark Preferences to set the options for the iBookmark tool.

iBookmark Preferences Dialog Box

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Details

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Keep iBookmark active until another tool is selected -- If using iBookmark to create multiple bookmarks (one right after the other), selectthis check box to keep the iBookmark tool active and alleviate the need to select the tool to create each bookmark. Once finished creatingbookmarks with iBookmark, simply select another ToolBox tool.

Add “...” to the end of long bookmark titles - Select this check box to add an ellipse (...) to the end of bookmark titles that are too long to display fully in the bookmark pane. (This doesnot seem to work.)

Magnification - Select an option from this drop-down list to specify the magnification setting for bookmarks created with iBookmark. See Common Features

for details on magnification settings.

Page Justification -- Page justification is set the alignment for the bookmark destination page. See Common Features for details on theoptions in this dialog box.

Enable keyboard shortcuts for bookmark creation -- The options in this group box will enable the shortcut keys that can be used to createparent and child bookmark levels in the bookmark structure. For the levels to be created, the specified key needs to be held down whilecreating the bookmark with the iBookmark tool.

* Insert lower level bookmark if CTRL key is pressed - Select this check box to create a lower level bookmark in the bookmark structure byholding down the CTRL key on the keyboard.* Insert lower level bookmark if SHIFT key is pressed - Select this check box to create a higher-level bookmark in the bookmark structure byholding down the SHIFT key on the keyboard.* Insert lower level bookmark if SHIFT and CTRL key is pressed - Select this check box to create the highest level bookmark in the bookmarkstructure by holding down both SHIFT and CTRL keys simultaneously on the keyboard.

OCR: Optical Character Recognition (OCR) is used with iBookmark to capture content in image-based documents. The options in this groupbox allow for OCR settings that ensure a higher accuracy rate in the OCR process.

* *Antialias Graphics:* If text within an image needs to be bookmarked and the image is in grayscale (not black/white), it may be beneficial toselect this option. The edges of the grayscale are smoothed out and the word(s) is captured more accurately. This has no effect on thereadability of graphics for the CCIT Group 4 TIFF images when copied.* *Antialias Text:* &nbspIf text is in grayscale (not black/white), it may be beneficial to selection this option. The edges of the grayscale aresmoothed out and the word(s) is captured more accurately. This has no effect on the readability of graphics for the CCIT Group 4 TIFFimages when copied.

Anti-aliasing is a technique of blending bitmap-based images and text to reduce the stair-stepping or jagged appearance. Inareas of transition, the edge pixels are blended to give a smoother appearance.

Use color image if high accuracy is required: If the document was scanned using color, select this check box recognized the color duringthe OCR process. This reduces the speed of the OCR process, however, the accuracy of the text will be much higher. * *Resolution:* The resolution refers to the number of pixels per square inch. The higher number of pixels used, the smoother and sharperthe image. The selection in this drop-down list determines the number of pixels recognized during the OCR process. The available resolutionchoices are: 72, 100, 150, 200, 240, 300, and 400.* *Additional Setup:* Click This button to open the Tiger OCR Setup dialog box. The language is selected here along with the level to beused when unrecognizable characters are encountered. The default settings are typically used.** The *Table OCR* should be selected if the document contains tables and the content within the tables needs to be bookmarked.** The *Remove new line (CR/LF) character* option, when selected, will remove carriage returns (CR) and line feed (LF) characters when theselected area to bookmark spans over more than one line.

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iBookmark, Tiger OCR Setup Dialog Box (Accessed from the Additional Setup Button)

ISICopy Preferences

Page Content:


Keeping ISICopy Active Until Another Tool is SelectedSelecting the Resolution for ISICopy GraphicInserting an Additional Line After Each Paragraph While Using ISICopy Pages

DetailsCopy Graphic if OCR accuracy is very lowKeep ISICopy active until another tool is selectedInsert an extra line break at the end of each paragraphAntialias GraphicsAntialias TextUse color image if high accuracy is requiredResolutionAdditional SetupResolution

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ToolBox > Help & Setting Tools > ISICopy Preferences

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Overview

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The ISICopy Preferences tool sets specific guidelines for the ISICopy, ISICopy Graphic and ISICopy Pages tools.

ISICopy Preferences Dialog Box

Examples

Keeping ISICopy Active Until Another Tool is Selected

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Click the menu option.ISICopy PreferencesClick the check box.Keep ISICopy active until another tool is selectedClick the menu option.ISICopyCreate a rectangle around the text to be copied. The ISICopy tool will stay active until another ToolBox or Acrobat tool is selected.

Selecting the Resolution for ISICopy Graphic

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Click the menu option.ISICopy PreferencesSelect 200 from the drop-down menu in the group box.Resolution Graphic CopyClick the menu option.ISICopy GraphicCreate a rectangle around the image to be copied and paste it into a word processing document. The resolution for the pasted imagewill be 200.

Inserting an Additional Line After Each Paragraph While Using ISICopy Pages

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Click the menu option.ISICopy PreferencesClick the check box.Insert an extra line break at the end of each paragraphClick the menu option.ISICopy PagesSelect a page range and click the button.StartPaste the page(s) into a word processing document. An extra line break will appear at the end of each paragraph.

Details

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Copy Graphic if OCR accuracy is very low

Enabling this option will inform the function to copy the selected text as a graphic if the content is not clear or legible enough to use OCR.

Keep ISICopy active until another tool is selected

Enabling this option will continuously have the text copy function enabled as your default mouse option until another tool is selected.

Insert an extra line break at the end of each paragraph

Enabling this option will add an additional line break so that if you are copying multiple paragraphs, the paragraph structure will bemaintained when pasted into a word processor

Antialias Graphics

This option will allow graphics that are not entirely black/white (grayscale) to be properly OCRed. This option will have no effect on thereadability of graphics for the CCIT Group 4 TIFF images when copied.

Antialias Text

This option will allow text that is not entirely black/white (grayscale) to be properly OCRed. This option will have no effect on the readability oftext for the CCIT Group 4 TIFF images when copied.

Use color image if high accuracy is required

This option will allow text that is recognized as color to be accurately OCRed. The speed will be reduced for text that is recognized as colorby the utility, however, the accuracy of the text will be much higher.

Resolution

You have the option to change the resolution of the function. The available resolution choices are: 72, 100, 150, 200, 240, 300, and 400.

Additional Setup

This button will open the Tiger OCR Setup dialog and will allow you to make any necessary changes to the OCR setup. The default settingswill be used for most users.

Resolution

You have the option to change the resolution of the function. The available resolution choices are: 72, 100, 150, 200, 240, 300, and 400.

.

ToolBox Preferences

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AccessOverviewDetails

Browse PreferencesExpand/Shrink Bookmarks PreferencesGeneral Preferences

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ToolBox > Help & Settings Tools > ToolBox Preferences

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Overview

Use this tool to set general options for ToolBox and for the and tools.Browse Expand/Shrink

ToolBox Preferences Dialog Box

Details

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Browse Preferences

Wait Interval -- Enter a number in the adjacent field to specify the length of time (in Seconds) each page is displayed when using the Browsetool.

Direction – The options in this group box (ie, Browse Forward, Browse Backward) are used to specify the direction in which the documentwill be browsed.

Start on Current Page – Select this check box to specify that the document will begin browsing from the currently displayed page when theBrowse tool is activated. If this option is not selected, the Browse tool will begin from either the first or last page of the document, dependingon the direction selected.

Expand/Shrink Bookmarks Preferences

All Levels – Select this radio button to expand all bookmark levels when using the Expand/Shrink Bookmark tool.

Expand Level – Select this radio button and enter a specific bookmark level in the adjacent field. For example if 2 were entered, andthen the Expand/Shrink Bookmarks tool was selected, the bookmarks would only expand down to the second level.

General Preferences

Maximum number of open documents – Enter a number in the adjacent field to specify the maximum number of PDF documents that canbe open in Adobe Acrobat at one time.

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The unit of measurement – Select a unit of measurement that will be used in the ToolBox dialog boxes. The options are:

InchesCentimeter

Reset Dismissed Message Boxes -- Click this button to enable all message boxes that were disabled by selecting the "Don’t show me thisagain" check box.

Reset Window Position and Size -- Click this button to reset all of the dialog boxes within Toolbox.

Customizing the Toolbar

Page Content:


CustomizingDetails

Reset Button

Access

ToolBox > Help & Setting Tools > ToolBox ToolBar > Customize Icon

Or

Overview

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Use the Customize tool to modify the ToolBox tool bar to contain only the preferred tool access icons. The option of rearranging the icons inthe tool bar also can be managed.

Customize Toolbar Dialog Box

Example

Customizing

Access the dialog box.Customize ToolbarTo remove a tool, select it from the list and click the button. The tool will be moved to the Current toolbar buttons Remove Availab

list. Note that even if a tool is removed from the toolbar, it still will be available from the ToolBox menu.le toolbar buttonsTo add a tool, select it from the list and click the button. Available toolbar buttons AddTo reorder the tools in the toolbar, select a tool from the list and click the or button.Current toolbar buttons Move Up Move Down

ToolBox 6.3 Help

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When the toolbar is open, the changes made are immediately applied and visible.

The Customize tool cannot be removed from or moved in the toolbar.

Details

Reset Button

Click this button to reset the toolbar to show all tools and to return the toolbar order to the default setting.