Consistent Format Leads to Efficient Review, Edward S. Tripp, August 17, 2010 (Con't)
Additional Considerations
For body text, the guidance is fairly clear, use Times New Roman and decide whether you are going to adopt 11 or 12 point black font for the body text in your documents. Tables tend to be straight forward for font size since agencies expect a 9 or 10 point font. Most companies choose a 9 point font to accommodate the large tables typically generated for submissions.
Headings, however, require additional thought and attention. As you begin to establish your style guide, consider the length of your headings. Do you want to follow the practice of the newspaper industry and use sans serif fonts for all headings or do you find that you have very long headings that benefit from a serif font to help your readers' eyes move from word to word? Figure 2 - Font Styles, shows an example of each.
| Sans Serif | Arial |
| Serif | Times New Roman |
Figure 2 - Font Styles
Do you want to use auto numbered headings or non-numbered headings (manually numbered) or both? The sole use of auto numbered headings becomes problematic in Module 3 of the eCTD since ICH decided to mix letters in with the numbers to distinguish product and substance.
It is extremely difficult to program Word to automatically give you a choice between 3.2.P.4.3 and 3.2. S.4.3 when documenting Validation of Analytical Procedures. Most find it more practical to allow for manually numbered headings.
Next, do you want to allow for headings that do not become part of the Table of Content (TOC)? The agency expects the TOC to be structured four levels deep. What do your authors do if they have the need for a fifth level? Your style guide should also deal with the structure of a TOC, Table of Figures, Table of Tables, and Table of Appendices. There are additional issues a style guide should address. For instance:
- How are captions and footnotes styled?
- What abbreviations are acceptable?
- What are the company rules around the use of abbreviations?
- What is the expectation for document headers and footers and how are they to be formatted?
Protection against a Plethora of Styles
An established style guide also improves the process of reviewing and accepting material from Contract Research Organizations (CROs). Ideally, a CRO complies with your established styles; alternatively, documents from the CRO can be reviewed and restyled upon receipt to prevent unexpected, downstream issues that cause delays.
In today's pharmaceutical environment, there are many products and associated documents that are obtained via partnership, merger or acquisition. Since many of the studies on a drug occur years before the submission filing, organizations find that if they simply use the documents as they exist, the submission has a minimum of two styles and formats. Manually changing the styles and format of the original organization's documents can be a costly proposition.
Styles Count
Both the creation and the review of a new product submission is an immense undertaking. In preparing the submission, strive to make it as easy as possible for the reviewer to follow your scientific findings and conclusions. The workflow and thought process of the reviewer is disrupted when the document he or she opens differs from what was reviewed previously. Having this happen many times in a single submission can lead to questions about quality and process control.
However, crafting a style guide is only the first step of a multi-step process for realizing consistent formatting throughout a submission document. Adherence requires education and training, ideally involving medical writers, authors and your quality control staff. Additionally, you may want to consider alternatives to a completely manual adherence process.
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