Hyperlinking Best Practices: Common Issue in PDF Rendition
Mar25

Hyperlinking Best Practices: Common Issue in PDF Rendition

“When you use Word templates with styles and make use of the MS Word ‘cross-referencing’ option, tables, figures, sections, etc. within a given page all are automatically [linked] to their target destinations. However, when you have the same table cross referenced on the same page four (4) times, after rendition to PDF, you must manually break those three (3) extra links and convert the text from blue to black. Do you have this issue or is your EDMS customized to take care of this automatically?”

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Should all Documents in an eCTD have a Table of Contents and Bookmarks?

Most documents in an eCTD submission that have more than four pages of content include a Table of Contents (TOC). When TOCs are present, files are bookmarked to match the TOC. Furthermore, when documents have Lists of Tables and/or Lists of Figures, the documents are bookmarked to match those entries as well. What if documents don’t contain a TOC?  Is it necessary to add one? Not necessarily. Bookmarks can be used to aid reviewers in...

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Analysis of New, Draft TGA (Australia) M1 CTD Guidance

I sat down to take a look at the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information. This is a whopper of a document (96 pages), carefully written to provide a wealth of additional information to sponsors. The document contains a number of major and minor changes, and has been re-formatted to make extensive use of bullet lists for greater clarity. The new guidance addresses subsequent data...

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Specifications for Organizing Study Datasets

A few months ago, FDA issued version 1.5.1 of Study Data Specifications. Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered and has no effect on the Table of Contents that is visible to a reviewer (created from the eCTD XML backbone)....

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Quality Cover Letter Helpful to eCTD Reviewers

Continued from last time… Notes from my discussion with Virginia Ventura. Virginia mentioned lack of a cover letter, or lack of a useful cover letter, as a significant issue. Although the cover letter is not a regulatory requirement, it serves as the reviewers’ “Road Map” to the submission, and Virginia can’t understand why a sponsor would not take advantage of the opportunity to provide clarity on the...

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