Time to Reconsider How You Write for the Regulatory Reader

With the continuing expansion of on screen tools for analyzing, manipulating, and using technical data it is worthwhile to take a moment and consider the implications of how we think about documents and document design in 2013.

Let me use as the starting point for this discussion my position that in the world of regulatory writing it is clearly time to retire the classic notion of a document that has been around since the Irish monks hung out in European monasteries scribing the ancient texts in Latin on bound pages of vellum. So, stop thinking about and judging documents as something going from page 1 to n and constrained by the classic measurements of “Letter size” and “A4.” 

Electronic regulatory submissions that are compiled for viewing on screen using a tool like Global Submit Review must be characterized by definitions decidedly different than what worked for an Irish monk. Think three dimensional.

Now you must think of documents in the manner of Suzanne Briet. In 1952, Briet created the following working definition for a document—“A document is the physical evidence that supports a fact.” I suggest her definition describes the mental model we must  now apply to regulatory submission documents in 2013. Documents are now defined by the user, not you. Why is it that way? Because of the tools they now use to navigate electronic documents.

The culture of reading in the regulatory domain has really evolved over the past five years. As Christine Rosen states in her article, People of the Screen, published in The New Atlantis:

“Every technology is both an expression of a culture and a potential transformer of it. In bestowing the power of uniformity, preservation, and replication, the printing press inaugurated an era of scholarly revision of existing knowledge. From scroll, to codex, to movable type, to digitization, reading has evolved and the culture has changed with it.”

It is important to keep in mind that research shows there is a distinct change in behavior when reading on-screen versus reading within the framework of “Letter size” and “A4.”

Some of the differences are relatively subtle and others are rather profound. For instance, the research of cognitive scientists like Mary C. Dyson, Andrew Dillon and many others has looked closely at how physical text layout impacts on screen reading. Papers from Megan Fitzgibbons, Stuart Moulthrop, and others consider behavior tendencies and strategies for searching large complex documents for specific pieces of information and the use of hypertext attributes (I'd call this the working application of Briet’s definition of a document.)

At this point in time I have met few in the medical writing industry who ever consider how there narratives and tabular displays impact the on-screen user. They just kept on building document content like they always have. I have yet to hear a medical writer talk about how paragraph length and density of detail impact on-screen reading speed.

I have met fewer still who consider the implications of reading pathways through and between documents as the on-screen reader now make considerable use of bookmarks, hyperlinks, and key term searches. They just keep on publishing to only third-level headers while the documents actually subordinate content to the 5th or 6th level header and many writers toss in hyper-links without much regard for utility of the link to the end-user. Keep in mind this quote from Megan Fitzgibbons:

“Literacy is a key component of the information seeker's side of the equation, because the abilities to locate, read, and evaluate texts are the basis of successful information gathering processes.”

The net-net I am trying to bring across here is that for information professionals to form effective principles of document design they must reconsider regulatory agents’ needs, attitudes, and ways of working with documents in the “electronic document age” and that information professionals must also understand the technical capabilities of the document interface tools in prevalent use by regulatory agents so that they can design documents today that will meet the changing needs of the reader 12 to 36 months from now.