Document Standards Should Form Foundation of eSubmission

The quality of electronic submission documents greatly impacts the “downstream” esubmission process, experts told PIR last week.

A high-quality document would have “electronic navigation aids such as bookmarks and hyperlinks,” Pam Pagnotta, principal consultant with Octagon Research Solutions, told PIR Aug. 23.

“Having authoring standards in place at the outset allows for greater consistency within and across departments” in your company, agreed John Lawrie, vice president of Process Solutions at Octagon. “It improves the quality of the look and feel of your esubmissions and goes a long way toward impressing FDA reviewers.”

But don’t make the common mistake of scanning PDFs. The image may look good on the screen, but the text cannot be searched and bookmarks must be manually typed. “The agency would prefer not to receive scanned images since they cannot copy and paste text from scanned files into their own review documents,” Pagnotta said.

Document standards boost submission timelines by minimizing document rework and automating publishing activities such as extraction of heading styles for bookmarks.

Know What You’re Getting Into

It is critical to have a clear idea of what document standards entail before implementing them, Pagnotta and Lawrie advise. Document standards are traditionally defined in a corporate style guide and include format and content standards.

Format standards include structural components such as text styles, line spacing, page margins, and table and figure formats. Content standards include spelling, abbreviations, capitalization, punctuation and cross-referencing.

A style guide is important because it fosters a corporate “look and feel,” Pagnotta said. Guides also help authors avoid reinventing the wheel with each esub, so they can focus on content, she added.

Document templates provide defined styles that support the overall style guide, she said. A template is a logically organized MS Word file that may contain: authoring styles, automated functionality through a toolbar, instructional text to provide authoring guidance and boilerplate text.

Templates can also be adapted to provide organization-specific wording. Templates with boilerplate text save time for authors and promote consistency throughout the organization, Pagnotta added.

Next Issue: Octagon experts Pagnotta and Lawrie on how to effectively and efficiently handle bookmarking, hyperlinking and PDF standards.