Many industry professionals once considered standardizing regulatory writing style conventions unnecessary and time-consuming. However, the pharmaceutical industry now recognizes its benefits for maximizing efficiency during regulatory submission development.
Writers frequently use standardization tools like style guides and lexicons. However, there is often confusion about their key differences, when to use them, and how these tools mitigate quality issues and promote efficiencies.
Styles Guides for Regulatory Documents: What and When
Style guide conventions should be used throughout document development to ensure consistency. These conventions should be simple. They can include guidance on:
- Grammar and punctuation (eg, the number of spaces after a period),
- Abbreviations (eg, a standard list of abbreviations and their definitions), and/or
- Sponsor-specific conventions (eg, the presentation of the pharmaceutical or medical device company name) and preferred terminology (eg, clarifying if “preclinical” or “nonclinical” should be used).
Style guides can also enable uniform document formatting and increase readability for regulatory agency review. For example, a style guide can dictate table presentation by outlining the font type/size, borders, and footnotes. Data tables are needed to support the major conclusions of a study but can often stretch across pages. When tables are positioned incorrectly or use various fonts, complex data interpretation can be even more challenging.
Clean and consistent formatting avoids confusing reviewers. Defining those conventions clearly in a style guide also helps ensure correct and consistent formatting across documents.
Medical Writing Lexicons: What and When
When a team is preparing a submission, making a specific list of terms can help keep the writing consistent. Submission lexicons outline the preferences related to consistent messaging, such as:
- Introductory text that should be used,
- A specific way the drug or medical device should be referenced, and/or
- The presentation of cross-document links/references.
Lexicons should supplement an overall house style guide/template suite rather than duplicate any conventions outlined in those resources.
Why Life Science Companies Use Standardization Tools
Quality may be compromised in various situations while developing documents. Using style guides and lexicons that clearly define style conventions can help prevent and mitigate these issues.
The authoring process can have many different writers who each have their own style. These writing styles can introduce inconsistent grammar or formatting. Furthermore, when writers are time crunched, they may disregard consistent text and data presentation, especially if guidance is unclear. Both scenarios may result in disjointed, difficult-to-read documents.
At the review stage, contributors may focus on editorial and formatting inconsistencies rather than the actual document content. Time spent addressing style guidance questions could have been better utilized for enhancing messaging or interpreting data.
When style conventions aren’t established early, later document development steps, such as quality control (QC) reviews, may also be affected. A document with many style inconsistencies can be challenging to QC. The writer may also have to address numerous style questions and corrections from QC reviewers if the style guidance is unclear. This increases the QC time required, which may then increase the document’s timeline and budget.
Sending a cleaner document to QC helps reviewers focus on finding real errors and saves time that would otherwise be spent on style issues or fixing mistakes. This process will yield a more effective QC and improve document quality.
Better Document Quality Benefits Regulatory Operations Groups
Style guides and lexicons can also provide value for Regulatory Operations and eCTD publishing teams. Lexicons can stipulate how cross-document links/references should be written. For instance, they might specify if eCTD module numbers are needed or if a particular font color should be used for links to other documents. Establishing these lexicon guidance preferences can also reduce follow-up questions from the publishing team and minimize the risk of misinterpreting the intended link destination. Thus, consistent presentation of cross-document citations affords additional efficiency for publishers.
The Value for Medical Writers and Technical Editors
Creating and using style guides and lexicons helps everyone write in the same style. It provides a central reference point for writers, editors, and publishers. This will minimize time (and budget) drainers such as debating conventions during comment resolution meetings or completing mass updates for consistency. Instead, reviews can focus on the content.
Importantly, style inconsistencies continue to have an impact even after document development is complete. Documents with style inconsistencies can distract regulatory reviewers from key messages and data. Furthermore, health authorities often have document formatting rules such as minimum font sizes and other elements that impact readability.
Failure to comply with these standards could trigger technical validation errors and contribute to a Refuse to File (RTF) when the regulatory agency won’t review a submission. While most stylistic elements won’t be the sole cause of an RTF, the cleanliness, consistency, and clarity of the conventions used across documents avoid distracting agency reviewers.
While it may seem simple to decide what punctuation, abbreviations, or standard text to include in a style guide or lexicon, this investment is critical to ensuring document quality across your teams and supporting their success.
The Certara Drug Development Solutions Document Quality group is highly experienced in creating and maintaining style guides and lexicons that are tailored to your writing team’s needs. Learn more about our Document Quality services.
