Susan E Caldwell

Susan E Caldwell

The use of a style guide gives documents a consistent look and feel. In turn, the reader’s comfort level is enhanced when reviewing files that are based on the same style guide. Consistent style decisions, derived from using a style guide, can make a document more persuasive, easier to understand, and of a high perceived quality. In fact, writing with consistency engenders the reader’s trust and confidence. Where regulatory documents are concerned, it’s a worthy goal to achieve these effects. Developing and executing an in-house style guide strategy is an effective way to confer these beneficial effects on individual documents, such as investigator brochures, and on compound regulatory documents, such as INDs, NDAs, or BLAs.

j0414037Many pharmaceutical, biotechnology, and medical device companies have no style guide. Or they may have a rough draft of an in-house style guide that they rely on. Style guides are often given a back seat in priority, along with SOPs and other infrastructure-supporting documents. Unfortunately, companies often realize they need a style guide only when a submission deadline looms–not the best time to develop a new style guide and improved writing habits.

But there is a way to quickly develop a style guide system that, if followed, will help authors produce documents that are stylistically consistent and pleasing to the eye. Here’s a list of five recommended style guides and their uses. When used modularly, as needed, they can become a flexible style guide system for most companies.

  1. AMA Manual of Style, A Guide for Authors and Editors, 10th Edition: This is the definitive style guide for regulatory documents, and has the mainstay style guide for most pharmaceutical and biotechnology companies for many years. The regulatory agencies are accustomed to reviewing documents written and edited using the AMA Manual of Style’s rules and guidelines. Using the AMA Manual of Style confers consistency and uniformity of editing to company documents that enhances their aesthetic appeal with reviewing agencies and other readers. The AMA Manual of Style should be a primary reference source for technical abbreviations, use of symbols, word use, capitalization and punctuation rules, and much more. If needed style rules are unavailable in the AMA Manual of Style, use the style guides described below as back-up resources. Copies of the AMA Manual of Style may be purchased from www.amazon.com.
  2. Citing Medicine, The NLM Style Guide for Authors, Editors, and Publishers, 2nd Edition: This online resource should be used as the style guide for references cited in regulatory documents. The International Conference on Harmonization (ICH) recommends that writers and editors adhere to the guidelines in the current version of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication when citing bibliographic references in regulatory documents. In turn, the current (October 2008) version of the Uniform Requirements recommends that authors and editors use as their bibliographic guide Citing Medicine, The NLM Style Guide for Authors, Editors, and Publishers, 2nd Edition (2007, updated 2009). This resource is the US National Library of Medicine’s (NLM’s) style guide for formatting references. Citing Medicine is available online, free of charge, as downloadable PDF files of the 26 separate, searchable chapters and 6 appendices.
  3. The ACS Style Guide: A Manual for Authors and Editors, 3rd Edition: Published by the American Chemical Society, this style guide should be used for chemical references, nomenclature, and abbreviations not found in the AMA Manual of Style. See also http://www.lib.berkeley.edu/CHEM/acsstyle.html (2nd Edition, 1997). Copies of the ACS Style Guide may be purchased from www.amazon.com.
  4. Chicago Manual of Style, 15th Edition: The Chicago Manual of Style should be used for general style rules that are not found in the AMA Manual of Style. See http://www.chicagomanualofstyle.org/home.html. Copies of The Chicago Manual of Style may be purchased from www.amazon.com.
  5. In-House Style Guide: This (ideally) short style guide should be developed in house. The objective is to pull together in one document the company’s abbreviations, specialized nomenclature, and preferred style conventions (especially if there are exceptions to primary style guide rules, such as those in AMA). Generally, such an in-house guide can be 50 or even 100 pages long. Or, it can be very brief if the mainstay style guide, such as AMA, captures most of the style rules that a company normally uses.

Depending on the company’s business, types of products, and stages of product development, these style guides can be used separately, or in combination, to address almost all style decisions that arise when writing and editing regulatory documents. Obviously, there are other choices in style guides besides those listed here. This list is presented to show how a group of well-chosen style guides can be effectively used to address style decisions, while minimizing the time required to put such a system in place. Acquire the published style guides, develop a short in-house style guide, and use them together–doing so will pay big dividends in document quality at submission time.

Copyright 2009-2011 Biotech Ink, LLC. All rights reserved.

3 responses »

  1. Thank you, Susan, this was very helpful.

  2. Myleene says:

    This article is indeed very useful!!!

  3. James Lewin says:

    I really enjoyed reading this article. I recently graduated pharmacy school, and instead of pursuing a typical career path in retail or hospital pharmacy, I chose to apply for a fellowship program. I am currently undergoing a fellowship in medical communications. Although medical writing is not a major part of the fellowship, I have developed a strong interest in medical writing and am trying to gain as much training as I can outside of my normal day to day responsibilitites. Sorry for rambling, now I will get to my main reason for leaving this reply.

    I have become the “go to” person at the company when a question related to medical or technical writing arises. This may seem odd as I am just an intern and only 6 months out of school, but the company is very small, has zero medical writers on staff, and the medcomm department consists of 3 people including myself. I have been editing, citing, and writing based on AMA format because I just assumed that this was the appropriate format to use among the pharmaceutical industry; however, I have never read or been told that AMA is the most widely used format. I asked the MedComm Director if our company had a preferred style manual for pubs, reg documents, and other materials. When I was informed that we did not, I recommended that we use AMA format. Then, after about a week, I began to slightly panic. What if I was wrong? What do I know? I am brand new to this field and just made an assumption regarding what I consider to be somewhat of a major company decision. I immediately jumped on my computer and came across your blog upon searching for confirmation that I made a sound decision.

    Sorry for the long-winded reply. Thank you for writing this article as my mind is now at ease.

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