Authoring Standards Streamline Electronic Submissions

Authoring standards can minimize problems and unexpected glitches such as inconsistent document formats, cost overruns and staff burnout when putting together electronic submissions, experts said last month at a Drug Information Association (DIA) conference.

“Don’t overlook or underestimate authoring standards as a way to achieve more efficient electronic submissions timelines,” said Robin Zumbrunnen, associate director of regulatory and technical services at Quintiles. Authoring standards are the standard formats and processes that should be used when a company is writing and producing any document that could be used in a regulatory submission, she said.

Standard formats and processes include Microsoft (MS) Word shells and templates, PDF rendering tools and techniques and internal standards guidelines. Typical esubmission documents include: study reports; meeting information and briefing packages about meetings with the FDA; annual reports; investigational new drug (IND) applications and investigator brochures.

Avoid Staff Burnout

Among the many reasons to embrace authoring standards for esubmissions, staff burnout should be the main reason. “Over time, staff can experience burnout if preventable issues surface often [during your esubmission] and are not addressed,” Zumbrunnen told attendees of DIA’s 19th Annual Electronic Document Management Conference in Philadelphia Feb. 8.

But authoring shells and templates are critical because an esubmission program will deal with hundreds, possibly even thousands, of documents coming together, she noted. And because multiple contributors create submission documents, they tend to have their own format preferences. Unchecked, this can mean many different formats and styles that are difficult to reconcile.

“Without templates and related standards, the end product of an electronic submission will take longer than necessary to produce, may lack consistency, [and] may not meet agency guidance requirements,” Zumbrunnen said.

Required elements of effective authoring templates include setting the right margins, font types and MS Word styles, she added.

Eli Lilly has had success developing its own internal “library of elements,” a central repository for text that is used in multiple documents such as scale definitions, and inclusion-exclusion criteria and objectives, said Karen Heraty, scientific communications consultant.

Build Your Own ‘Library’

Advantages of the library include being able to quickly access needed text without having to search for previous examples. It has also helped the company reach agreement on standards, Heraty said, by reducing the “possibility of defining a scale or other text [differently] that should be standard within one drug development program,” she noted. It also helps to speed review time if reviewers know that standards were used and to follow them.

Lilly began the project after identifying the need for it, Heraty said. The company recognized that it had many teams creating drug-specific or study type-specific templates. Those multiple templates proved difficult to manage and keep updated with existing company standards, she said.

Lilly knew it wanted a storage area that was easy to use from a technology perspective; was inexpensive and intuitive; and could provide version control. It chose a Documentum-based interface and began with an internal group that had standard templates in place, Heraty said.

But the program still encounters challenges, she said. For starters, it remains difficult to keep the elements updated, and the company is still figuring out the best way to organize the information. “A library is only useful if people can find the information they are looking for,” Heraty added.

Finally, Lilly is still seeking a tool that allows the library to be part of the company-wide word processing program. — Michael Causey