Consistent Format Leads to Efficient Review
| Edward S. Tripp, August 17, 2010 |  |
The Food and Drug Administration (FDA) as well as other governing agencies like the European Medicines Agency (EMA) provide guidance on the use of fonts, font sizes in the body of a document, font sizes in tables and margin sizes in documents.
Unfortunately, unless a company provides additional specific guidance, there remains room for interpretation by the author. These individual interpretations technically may adhere to agency guidance, but ultimately result in variances within a submission that cause distraction to the reviewer.
For example, the FDA states, "Times New Roman, 11 or 12-point font ... is adequate in size for reading narrative text."1. This guidance allows an author to ask, "Do I use 11 or 12 point? What do I use for headings? Do I just use a black font? Colors are nice!"
From the Reviewers Perspective
Remember, any single document written for a biopharmaceutical submission is a small piece of the overall scientific report on a product's safety and efficacy. The submission is a massive compilation of reports and data, collected over many years and compiled to make a reviewable case for providing a product to the consumer.
So imagine the reviewer is reading a Non Clinical Overview and, from that document, follows a link to a referenced Dose Range-Finding Toxicity Study. Upon opening the study, all the text is in blue (blue is nice) and the font size is smaller than in the previous document.
Ask yourself, what happens next? Does the reviewer continue smoothly, reading the scientific content to the Dose Range-Finding Toxicity Study, or does he or she stop and wonder, "why is there inconsistency between these two related documents?"
The reviewer's pause won't result in a rejection by the agency, but inconsistencies in documents, even small ones that cause a reviewer to pause and question practices, attention to detail and attention to quality are undesirable. Quite simply, it is not an area where you want the reviewer's attention focused.
Getting Started
The first step in achieving consistent style and format to your electronic submission documents is to develop and adopt a companywide style guide for electronic regulatory submissions. A style guide provides the authors and reviewers with clarity on how your company intends to interpret the regulatory authority guidance and how your company documents appear to the reviewer.
Take a simple example such as page size and margins. The FDA reference above provides the following guidance on page size and margins in section IV D:
"The print area for pages should fit on a sheet of paper that is 8.5 inches by 11 inches.
You should allow a margin of at least 1 inch on the left side of page (to avoid obscuring information when the pages are subsequently printed and bound) and 3/8 of an inch on the other sides. For pages in landscape orientation, you should allow 3/4 of an inch at the top to allow more information to be displayed legibly on the page. Header and footer information can appear within these margins as long as it is not within 3/8 of an inch of the edge of the 8.5 by 11 inch page, because the text may be lost upon printing or being bound."2
You can adopt this guidance directly or you can decide that using a 1 inch margin on all sides of an 8.5 by 11 inch page falls inside these requirements and is easier to train on, implement and identify inconsistencies during the QC review.
Meeting International Expectations
But, in our global environment, you likely produce submissions for more than one country. So now you may ask, what formatting standards do we adopt for submissions that require A4 paper? In January 2004, EMA adopted The International Conference on Harmonisation (ICH) Electronic Common Technical Document (eCTD) Specification V3.2.2. In addressing page size and margins, the eCTD specification states, "A sufficient margin (at least 2.5 cm) on the left side of each page..." The specification is silent on the remaining margins for portrait documents. Do we keep 1 inch (2.54 cm) margins all the way around or keep the same print area so that the document does not repaginate when the paper size changes. One solution is to set portrait margins for A4 paper to 3.42 cm. top and bottom, 2.54 cm. left and 1.95 cm. right. This matches the print area of an 8.5 by 11 inch page with one inch margins and ensures your submission complies with US and European agency guidance. Figure 1 - Margins, illustrates this configuration.
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Figure 1 - Margins |
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