ectd submissions: guide to bookmarking and hypertext linking (last updated: march-09) prepared by:

eCTD Submissions: Guide to eCTD Submissions: Guide to BookMarking BookMarking

and and Hypertext LinkingHypertext Linking

(Last Updated: March-09)(Last Updated: March-09)

PreparedPrepared By: By:

TABLE OF CONTENTSTABLE OF CONTENTS

IntroductionIntroduction

Benefits / Why NeededBenefits / Why Needed

RiskRisk

General GuidelinesGeneral Guidelines

How Hypertext linking is doneHow Hypertext linking is done

Bookmark HierarchyBookmark Hierarchy

Bookmark Naming GuideBookmark Naming Guide

Contact DetailsContact Details

eCTD submissions: Guide to eCTD submissions: Guide to Bookmark and Hypertext LinkingBookmark and Hypertext Linking

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INTRODUCTIONINTRODUCTION

BookMarking and Hyperlinking are methods to improve BookMarking and Hyperlinking are methods to improve navigation between the information within the documents navigation between the information within the documents and between more then one document.and between more then one document.

BookMarking and Hyperlinking are techniques available BookMarking and Hyperlinking are techniques available with PDF authoring tools.with PDF authoring tools.

TOC (Table of Content) can be created in long PDF file and TOC (Table of Content) can be created in long PDF file and link/bookmark to each item in TOC can be created using link/bookmark to each item in TOC can be created using HyperLinking HyperLinking

Hypertext links can be created throughout the body of the Hypertext links can be created throughout the body of the document to supporting annotations, related sections, document to supporting annotations, related sections, references, appendices, tables, or figures that are not references, appendices, tables, or figures that are not located on the same page.located on the same page.

Excessive use of hyper linking and hyperlink to obvious Excessive use of hyper linking and hyperlink to obvious external links are discouragedexternal links are discouraged


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BENEFITS / WHY NEEDEDBENEFITS / WHY NEEDED

For smooth navigationFor smooth navigation

To Improve reviewabilityTo Improve reviewability

Lack of hyperlinks impedes reviewLack of hyperlinks impedes review

Inadequate links undermine reviewer confidenceInadequate links undermine reviewer confidence

One instance per page generally okOne instance per page generally ok

Links to/from Modules 2 & 5 EssentialLinks to/from Modules 2 & 5 Essential


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RISKRISK

Hyperlinks should not be overusedHyperlinks should not be overused

Some documents may be subsequently replaced or Some documents may be subsequently replaced or appended, possibly rendering the link obsolete, so linking appended, possibly rendering the link obsolete, so linking should be used cautiously. should be used cautiously.


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GENERAL GUIDELINESGENERAL GUIDELINES

For documents with a table of contents, provide bookmarks For documents with a table of contents, provide bookmarks and hypertext links for each item listed in the table of and hypertext links for each item listed in the table of contents including tables, figures, publications, references, contents including tables, figures, publications, references, and associated appendices. These bookmarks and and associated appendices. These bookmarks and hypertext links are essential for efficient navigation through hypertext links are essential for efficient navigation through documents. documents.

So User should make the bookmark hierarchy identical to So User should make the bookmark hierarchy identical to the table of contents. Navigation efficiency is also improved the table of contents. Navigation efficiency is also improved by providing hypertext links throughout the body of the by providing hypertext links throughout the body of the document to supporting annotations, related sections, document to supporting annotations, related sections, references, appendices, tables, or figures that are not references, appendices, tables, or figures that are not located on the same page.located on the same page.


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GENERAL GUIDELINES(Cont..)GENERAL GUIDELINES(Cont..)

In, General hypertext links are encouraged within the eCTD In, General hypertext links are encouraged within the eCTD to facilitate swift navigation around the dossier, should not to facilitate swift navigation around the dossier, should not be overused. The eCTD should be structured and links be overused. The eCTD should be structured and links provided in such a way as to ensure that the reviewer is provided in such a way as to ensure that the reviewer is constantly aware of the overall structure and narrative flow constantly aware of the overall structure and narrative flow of the dossier. of the dossier.

For example, Module 3 is highly structured and defined to a For example, Module 3 is highly structured and defined to a relatively low level of granularity in the specification. relatively low level of granularity in the specification. Therefore, only minimal use of hyperlinks should be Therefore, only minimal use of hyperlinks should be necessary.necessary.

When the same citation appears on a page more than once, When the same citation appears on a page more than once, it is recommended that a link only to the first instance of it is recommended that a link only to the first instance of the citation per page is providedthe citation per page is provided


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The greater number of hyperlinks contained in an eCTD The greater number of hyperlinks contained in an eCTD dossier, the longer it takes to technically validate the dossier, the longer it takes to technically validate the submission, and the greater likelihood of non-functioning submission, and the greater likelihood of non-functioning hyperlinks. hyperlinks.

The use of ‘obvious’ and therefore redundant external links The use of ‘obvious’ and therefore redundant external links is discouraged with the structure of the eCTD and can is discouraged with the structure of the eCTD and can therefore also navigate using the ToC created for a therefore also navigate using the ToC created for a submission or assembled during the current and cumulative submission or assembled during the current and cumulative view on an eCTDview on an eCTD

The hyperlinks between the documents are only to be The hyperlinks between the documents are only to be included where considered necessary and considered to included where considered necessary and considered to add real value.add real value.


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If the document is referred from another document, the If the document is referred from another document, the reference details should match eCTD titles pertaining to the reference details should match eCTD titles pertaining to the same documents.same documents.

If the title visible by the review tool in the eCTD (i.e. Node If the title visible by the review tool in the eCTD (i.e. Node Name in KnowledgeNET) and the reference details in Name in KnowledgeNET) and the reference details in referring document are different, the purpose of referring document are different, the purpose of hyperlinking may be negated.hyperlinking may be negated.


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HOW HYPERTEXT LINKING IS HOW HYPERTEXT LINKING IS DONEDONE

PDF Writer(Adobe Acrobat ) allows Hypertext LinkingPDF Writer(Adobe Acrobat ) allows Hypertext Linking

Majority of Hypertext Linking(like TOC) is to be done within Majority of Hypertext Linking(like TOC) is to be done within the same document where reference to other document is the same document where reference to other document is not required.not required.

Hypertext Linking to another document within the Hypertext Linking to another document within the submission needs to be done using relative path only. submission needs to be done using relative path only. Absolute path using reference to root directory or hard disk Absolute path using reference to root directory or hard disk becomes non functional once documents are loaded in becomes non functional once documents are loaded in repositoryrepository


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HOW HYPERTEXT LINKING IS HOW HYPERTEXT LINKING IS DONEDONE

Relative path needs consistency in folder structure and folder Relative path needs consistency in folder structure and folder names, meaning that if summary of clinical efficacy in M2 names, meaning that if summary of clinical efficacy in M2 needs to be linked with actual document in M5, the relative needs to be linked with actual document in M5, the relative link would look like ..\m5\53-clin-stud-rep\m5-3-5-reports-of-link would look like ..\m5\53-clin-stud-rep\m5-3-5-reports-of-efficacy-and-safety-studies\doc.pdfefficacy-and-safety-studies\doc.pdf

To achieve this, the working folder should maintain the same To achieve this, the working folder should maintain the same folder structure as Published version of eCTDfolder structure as Published version of eCTD

Since such relative links are normally required only between Since such relative links are normally required only between M2 and M5, it is not difficult to achieve M2 and M5, it is not difficult to achieve

(Contact us in case you require predefined working folder (Contact us in case you require predefined working folder structure.structure.

Caution: Caution: AvailableAvailable on demand only to on demand only to

KnowledgeNET eCTD publishing users)KnowledgeNET eCTD publishing users)eCTD submissions: Guide to eCTD submissions: Guide to Bookmark and Hypertext LinkingBookmark and Hypertext Linking

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BOOKMARK HIERARCHYBOOKMARK HIERARCHY BookMark Hierarchy should be similar to TOC.BookMark Hierarchy should be similar to TOC.


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BOOKMARK NAMING GUIDEBOOKMARK NAMING GUIDE

Use more intuitive names while creating BookMarks.Use more intuitive names while creating BookMarks.


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CONTACT DETAILSCONTACT DETAILS

1010thth Floor Akshat Towers, Floor Akshat Towers,

S. G. Highway,S. G. Highway,

Ahmedabad – 380 054Ahmedabad – 380 054

IndiaIndia

Phone: +91-79-66311984/5, 2687 0778Phone: +91-79-66311984/5, 2687 0778

USA : 847-307-5937/50USA : 847-307-5937/50

[email protected]


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ectd submissions: guide to bookmarking and hypertext linking (last updated: march-09) prepared by:

Documents

hyperlinking hypertext

general hypertext links

review inadequate links

obvious external links

essential ectd submissions

essential links tofrom

ok links tofrom modules

details ectd submissions