An In-House Style Guide Strategy for Regulatory Documents

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.

Many 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, 2^nd 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 (2^nd 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.

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