Bookmarks, Hyperlinks Key to Successful Esubmission Programs

Creating effective bookmarks and hyperlinks in any esubmission program begins in the MS Word document and continues with rendering the document to PDF, Octagon Research Solutions experts told PIR recently.

PDF is a commonly used format for document review and annotation during the internal review cycle as well, so MS Word may need to be "rendered to PDF at various points in the author-review-approval process," said Pam Pagnotta, principal consultant at Octagon. "Standards need to be developed around the settings and processes used to create the PDF, as well as what should be bookmarked or hyperlinked and by whom," she added.

Part of the challenge is that each PDF rendering tool is somewhat different, Pagnotta noted. However, they must contain certain settings to generate PDFs that meet FDA requirements. Some of those settings include:

PDF version must be 1.4; Font embedding must be set to "Embed All Fonts" or the equivalent; Security should not be set "on" the documents; and Document Open Solutions should be set to "Bookmarks and Page," unless there are no bookmarks. In that case, it should be set to "Page Only."

If the PDF tool you select allows it, Pagnotta recommended also setting the bookmark options to convert the appropriate Word styles to bookmarks. Also, set the bookmark magnification setting to "Inherit Zoom."

Bookmarks appear in the navigation pane of Adobe Acrobat and mirror the structure of the table of contents (TOC), Pagnotta said.

Whenever possible, text-based PDF source documents should be utilized, Pagnotta said. And remember to prepare TOCs for all documents that would have TOCs if they were in paper format.

Those eTOCs should be well-structured, informative and allow the reviewer easy navigation throughout the document. Bookmarks should also be provided for each item in the TOC, and that includes tables and figures, she said.

Additional hypertext links should be created throughout the body of the document to supporting annotations, related sections, appendices, tables or figures, Pagnotta added. Ultimately, standards for bookmarking and hypertext linking for scanned documents should meet the same requirements as for any other document.

Designed properly, hypertext links should connect one location of a document, or "the source," to information in another location, or "the target," Pagnotta said. The target of the bookmarks and hyperlinks may be within the same document or in a different document.

Esubmission-ready means that all bookmarks have been created and cross-references have been hyperlinked, including a hyperlinked TOC, she noted. -- Michael Causey