eCTD Submissions: Guide to BookMarking and Hypertext Linking (Last Updated: March-09)

1. eCTD Submissions: Guide to BookMarkingand Hypertext Linking(Last Updated: March-09) Prepared By:

2. TABLE OF CONTENTS • Introduction • Benefits / Why Needed • Risk • General Guidelines • How Hypertext linking is done • Bookmark Hierarchy • Bookmark Naming Guide • Contact Details eCTD submissions: Guide to Bookmark and Hypertext Linking

3. INTRODUCTION • BookMarking and Hyperlinking are methods to improve navigation between the information within the documents and between more then one document. • BookMarking and Hyperlinking are techniques available with PDF authoring tools. • TOC (Table of Content) can be created in long PDF file and link/bookmark to each item in TOC can be created using HyperLinking • Hypertext links can be created throughout the body of the document to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page. • Excessive use of hyper linking and hyperlink to obvious external links are discouraged eCTD submissions: Guide to Bookmark and Hypertext Linking

4. BENEFITS / WHY NEEDED • For smooth navigation • To Improve reviewability • Lack of hyperlinks impedes review • Inadequate links undermine reviewer confidence • One instance per page generally ok • Links to/from Modules 2 & 5 Essential eCTD submissions: Guide to Bookmark and Hypertext Linking

5. RISK • Hyperlinks should not be overused • Some documents may be subsequently replaced or appended, possibly rendering the link obsolete, so linking should be used cautiously. eCTD submissions: Guide to Bookmark and Hypertext Linking

6. GENERAL GUIDELINES • For documents with a table of contents, provide bookmarks and hypertext links for each item listed in the table of contents including tables, figures, publications, references, and associated appendices. These bookmarks and hypertext links are essential for efficient navigation through documents. • So User should make the bookmark hierarchy identical to the table of contents. Navigation efficiency is also improved by providing hypertext links throughout the body of the document to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page. eCTD submissions: Guide to Bookmark and Hypertext Linking

7. GENERAL GUIDELINES(Cont..) • In, General hypertext links are encouraged within the eCTD to facilitate swift navigation around the dossier, should not be overused. The eCTD should be structured and links provided in such a way as to ensure that the reviewer is constantly aware of the overall structure and narrative flow of the dossier. • For example, Module 3 is highly structured and defined to a relatively low level of granularity in the specification. Therefore, only minimal use of hyperlinks should be necessary. • When the same citation appears on a page more than once, it is recommended that a link only to the first instance of the citation per page is provided eCTD submissions: Guide to Bookmark and Hypertext Linking

8. GENERAL GUIDELINES(Cont..) • The greater number of hyperlinks contained in an eCTD dossier, the longer it takes to technically validate the submission, and the greater likelihood of non-functioning hyperlinks. • The use of ‘obvious’ and therefore redundant external links is discouraged with the structure of the eCTD and can therefore also navigate using the ToC created for a submission or assembled during the current and cumulative view on an eCTD • The hyperlinks between the documents are only to be included where considered necessary and considered to add real value. eCTD submissions: Guide to Bookmark and Hypertext Linking

9. GENERAL GUIDELINES(Cont..) • If the document is referred from another document, the reference details should match eCTD titles pertaining to the same documents. • If the title visible by the review tool in the eCTD (i.e. Node Name in KnowledgeNET) and the reference details in referring document are different, the purpose of hyperlinking may be negated. eCTD submissions: Guide to Bookmark and Hypertext Linking

10. HOW HYPERTEXT LINKING IS DONE • PDF Writer(Adobe Acrobat ) allows Hypertext Linking • Majority of Hypertext Linking(like TOC) is to be done within the same document where reference to other document is not required. • Hypertext Linking to another document within the submission needs to be done using relative path only. Absolute path using reference to root directory or hard disk becomes non functional once documents are loaded in repository eCTD submissions: Guide to Bookmark and Hypertext Linking

11. HOW HYPERTEXT LINKING IS DONE • Relative path needs consistency in folder structure and folder names, meaning that if summary of clinical efficacy in M2 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-efficacy-and-safety-studies\doc.pdf • To achieve this, the working folder should maintain the same folder structure as Published version of eCTD • Since such relative links are normally required only between M2 and M5, it is not difficult to achieve (Contact us in case you require predefined working folder structure. Caution: Available on demand only to KnowledgeNET eCTD publishing users) eCTD submissions: Guide to Bookmark and Hypertext Linking

12. BOOKMARK HIERARCHY • BookMark Hierarchy should be similar to TOC. eCTD submissions: Guide to Bookmark and Hypertext Linking

13. BOOKMARK NAMING GUIDE • Use more intuitive names while creating BookMarks. eCTD submissions: Guide to Bookmark and Hypertext Linking

14. CONTACT DETAILS 10th Floor Akshat Towers, S. G. Highway, Ahmedabad – 380 054 India Phone: +91-79-66311984/5, 2687 0778 USA : 847-307-5937/50 enquiry@knowledgenet.in eCTD submissions: Guide to Bookmark and Hypertext Linking