Regulatory Writing Must Be "Fit for Function" Not Perfect

Documents for the medical regulatory audience do not have to be perfect. Rather, they have to be "fit for the intended function."

I suggest to you that the majority of people associated with drug and device development do not either understand or appreciate this concept. I also suggest to you that the majority do not understand that you apply different document designs to different document genres. Which in turn means you have different standards for different genre. Fit for function means you do not work to one standard.

Fit for function means a document is built and judged by standards that are determined by audience and the task or role the document will take when in the hands or on the computer screen of the specified audience.

A few weeks back I was working with a development team that judges all of their work by one standard. No matter what they are writing, the team judges their handiwork by their personal standards for a research manuscript. This one standard is applied to clinical study reports, protocols, and investigator brochures. I know this to be the case because review comments are often predicated with statements like: "Well, when I was writing manuscripts we always did.............in the Discussion Section. We need to do that in this report." or "I think the reviewers at the agency would find this very interesting to read. So let's expand the discussion here." and "You have a hyphen break at the end of the line in this paragraph. We cannot have mistakes like this in our documents."

Fit for function places focus squarely on the elements that matter, that is, the underlying logic of what the document is to convey or enable the reader to do. So in the world of drug and device development, this means authoring teams have to move away from the notions that when creating documents for regulatory readers, they are either simply reporting data or writing for an audience interested in knowledge acquisition. Working to either of those standards guarantees that your documents will not be fit for function. Rather, documents must be built following the underlying logic of what the reader is trying to do with the document.

More on how we characterize the logic of document genres in my next post.