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The Importance of Style…in Regulatory Documents

September 7, 2017 | Ann Brown, Document Services Manager | Regulatory Operations

When I think of style, the first thing that comes to mind is fashion. Being stylish is to wear clothes that are becoming to your size and shape (you look good!) and are functional, that is, they keep you warm in winter and cool in summer. But, style goes beyond clothing or other things like interior design, automobiles, architecture, etc.

In the world of regulatory writing, how your document presents and how it performs are critically important if it is to meet the rigorous standards of electronic submissions to worldwide regulatory agencies.

Three Tenets of Style

Basically, there are 3 important tenets of style when it comes to regulatory writing:

  1. follow a style guide,
  2. have authors trained in the use of Microsoft Word and its associated templates, and
  3. use well-designed templates that contain built-in styles.

In this post, I will concentrate on the importance of well-designed templates and their subsequent impact on an electronic submission. Style guides and training will be covered in a future post. Stay tuned!

The Importance of Well-designed Templates

Well-designed templates have built-in styles that allow for a clear, consistent format across the document. More important than looking good, they meet regulatory agency requirements.

As a reminder, to be compliant with the FDA’s guidance, submissions must be done electronically for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) as of this past May. Beginning 05 May 2018 , commercial Investigational New Drug Applications (INDs) and Master Files must also be submitted using eCTD format.

To appreciate the complexity of electronic submissions, in the eCTD structure, there are five modules just for an IND. Each module comes with specific requirements to make it compliant with regulatory requirements. For example, Module 3 – Drug Substance and Drug Product – alone has 57 individual templates (yikes!!). In this regard, electronic submissions are much more complicated than the “easy” days of paper submissions.

What Constitutes a Well-designed Template?

Consistency is an important feature of templates. Most templates will include styles such as (heading) levels, table and figure captions, regular text, table cells, internal cross‑referencing, and bullets and numbering, to name a few. Consequently, as shown in the example below, by applying Heading 1 to the highest level in each new section, that Heading 1 will have the same font type, font size, placement, and spacing wherever it appears in the document.

This example is for a Module 5 Clinical Study Report. It displays the available Styles Panel in the left pane, the styles in use within the document in the middle pane, and examples of how those styles display on the right. You can easily see how the various styles differ from one another while maintaining consistency among like styles such as the two Heading 1 examples.

A way to make consistency easier for the writer is through ribbons. In Microsoft Word, ribbons (formerly called toolbars) are basically shortcuts to reach a desired outcome. For example, prior to the expansion of ribbons, if you wanted to insert a symbol, you would have to drill down in the Symbols dialog box (below left) and choose the Subset you needed, and then search for the exact symbol you wanted. Instead of all this, you can now simply go under the INSERT tab and click on the Symbol down arrow and select from the most common symbols that are displayed or look under “More Symbols” if needed (below right).

Another feature of well-designed templates is that, when the user applies certain styles, they automatically create the Table of Contents, List of Tables, and List of Figures. In turn, when the Word document is rendered in Adobe Acrobat, these styles can be selected to become bookmarks in the PDF file.

Further, correct styles allow for linked cross-referencing to items such as tables, figures, sections, and appendices. And the true beauty of this is that, as edits are made, the software automatically updates changes to the numbers and subsequent links to these items.

Furthermore, well-designed templates contain an outline structure that facilitates navigation for the reviewer. They typically also include instructions for guiding the author in the proper placement of text and what information to include.

Importantly, when used properly, styles allow for ease of passage through the rigors of the electronic gateway to get your submission into the hands of the agency reviewer.

Since none of the above is either simple or intuitively obvious, having well‑designed templates removes some of the burden from the medical writer and allows him/her to focus on the content of the document rather than dealing with formatting issues.

Benefits of Using Templates

You can easily see that if you had to do all this on your own, it would be overwhelming. Fortunately, you don’t have to worry about creating templates since there are commercially available ones. Generally, companies that develop Regulatory Affairs software also offer eCTD templates that can be purchased. Some larger pharma companies, or those with more resources, sometimes develop their own templates for regulatory documents.

Moreover, as noted above, using a well-designed template lessens the stress on the authors, usually regulatory medical writers, who are tasked with reading and interpreting results from clinical trials. Instead of being worried about whether they are formatting their documents correctly, they can concentrate on the actual content.

(For more about regulatory medical writing, please see our posts on skills you need to be a good regulatory medical writer and what a regulatory medical writer does all day .)

Of course, this is true assuming the writers have been trained in using Microsoft Word and understand the features of the respective templates. Keep an eye out for a future post about training.

The Goal of Appropriately Using Styles

The goal of using styles in a well-designed template is 3-fold:

  1. It meets regulatory requirements and will pass through the electronic gateway.
  2. The use of proper styles results in a consistent, professional appearance throughout the document. Not only does the document look good, but by being uniform, it allows the reader to concentrate on the content and not be distracted by irregularity of style.
  3. It automatically generates a way to move through the document via the Table of Contents and cross‑references in both Word and Acrobat, and via the bookmark panel in Acrobat. This is an 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. You don’t want that to happen to you!

As a CRO, we have experience with a wide variety of templates. If you would like more information on Microsoft Word templates, style guides, or training, we can help. Don’t hesitate to contact us!

Photo image courtesy of Ambro from freedigitalphotos.net.

Category: Regulatory Operations
Keywords: MS Word template, writing style guide, regulatory medical writing

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