05 Mar 2024 │ Euan Griffiths, Senior Quality Control Specialist │ Medical Writing Services
When we think of medical writing, style is not the first thing that springs to mind. It is, however, crucial to ensure quality and consistency within a document, as well as essential to meet rigorous regulatory submission guidelines.
Style, in medical writing and academic writing in general, has a broader meaning that encompasses not only the way a document is written, but also the structure and conventions that it must adhere to in order to be published. Fortunately, medical writers have various tools and skills necessary to meet stringent regulatory requirements.
There are 3 important tenets to style when it comes to writing:
- using a well-designed template,
- having authors who are trained in the use of the Microsoft Word and its associated templates, and
- following a style guide.
Before we explore why templates and style guides are important, let’s define them.
What are templates?
Well-designed templates have built-in styles that allow for a clear, consistent format across the document.
Most templates in Microsoft Word will include styles for the various section (heading) levels, for table and figure captions, for regular text, for table cells, for internal cross-referencing, and for bullets and numbering, to name a few.
For example, if we apply Heading 1 to the highest level in each new section, Heading 1 will have the same font type, font size, placement, and spacing applied wherever it appears in the document. This same principle is true for all styles.
Further, by using the appropriate styles, the template can then automatically create the Table of Contents, List of Tables, and List of Figures. In turn, when the document is rendered in Adobe Acrobat as a .pdf file, those styles present in the Word document will be used to create the bookmarks and provide a navigation tool for reviewers.
What is a style guide?
A style guide, also known as a style manual, is a set of instructions in the use of grammar, punctuation, and formatting of a document. In the medical writing field, a style guide may be provided to the writer with specific rules set by the biopharmaceutical company. These rules might include agreed-upon terminology or naming conventions for the developmental drug or guidance on how to refer to participants in a study (e.g., patient, subject, or study participant). Most professional publications will adhere to one style such as the American Medical Association (AMA) or Council of Science Editors (CSE). Just as the art of writing is an evolving process, these style guides are constantly updated, and writers must remain current with the latest style requirements.
Why use templates and follow a style guide?
There are several reasons for using templates and style guides. Let’s consider three of them:
- First, templates automatically generate a way to navigate through the document via the Table of Contents and cross-references in both Word and Acrobat, and via the bookmark panel in Acrobat. The software will keep track of your various links and automatically update them as edits are made. This is the most important feature of styles because it allows for the regulatory agencies to easily navigate the document. The FDA does not want to click more than twice to reach a targeted screen. More than one company has failed to meet FDA requirements simply because their links did not go to the proper target.
- Second, style guides help ensure responsible and ethical accreditation of research. Documents in medical writing are not produced in a vacuum; they build upon prior research and the source of that research must be correctly acknowledged. The style guide provides a framework to cite published work and facilitate knowledge sharing and further research.
- Third, both templates and guides provide a consistent structure, terminology, and format throughout the document. By being uniform, it allows the reader to concentrate on the content and not be distracted by irregularity of style. Furthermore, medical writing often involves multiple authors working collaboratively on a single document, and thus an established set of rules helps to ensure consistency across all the medical writers and across all the documents involved for that particular developmental drug.
In summary, good style in medical writing is a product of the skilled use of templates and style guides; these tools are vitally important in creating a foundation for consistent and effective messaging.
If you would like more information on Microsoft Word templates or style guides, we can help. Don’t hesitate to contact us!
Euan Griffiths, PhD
Euan Griffiths, PhD, is a Senior Quality Control Specialist in the Medical Writing Services group at Syner-G. Euan has worked in the Life Sciences industry for 9 years in quality control (QC) and project management. As a member of the Medical Writing Services QC team, Euan checks a wide variety of medical documents to ensure accurate, consistent, and high quality deliverables. In addition to experience in the field of clinical research, Euan taught academic writing for 8 years at Meredith College and UNC Chapel Hill, where he earned his doctorate in Comparative Literature.