Abstract
The hallmarks of quality regulatory documents are clean data, a well-planned data analysis plan, clear writing, and a neat, well-organized document. Taken together, they lead to a high-quality document, may enhance or maintain the image of the sponsor, and can facilitate the review of documents by regulatory agencies. This chapter focuses on document appearance, describing best practices by which a high-quality, consistent, and professional appearance may be achieved using templates and style guides. It also focuses on the use of both paper files and electronic documents for regulatory submissions and on the creation and maintenance of templates and a style guide.
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References
International Conference on Harmonisation (ICH). Guidance for Industry. M4. Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. 13 January 2004. Available at http://www.fda.gov/cber/gdlns/m4ctd_OnlinePDF.pdf. Accessed 27 February 2008.
Foote MA, Hecker S, Style — what it is and how to get it. DIA Forum 2003; 39: 32–35.
US Department of Health and Human Services (US DHHS). Food and Drug Administration. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Electronic Format — General Considerations, Revision 1. October 2003. Available at http://www.fda.gov/cder/guidance/index.htm#electronic_submissions. Accessed 27 February 2008.
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© 2009 Birkhäuser Verlag Basel/Switzerland
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Yuen, J., Rood, D.L. (2009). Templates and style guides: The nuts and bolts of regulatory documents. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_3
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_3
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Publisher Name: Birkhäuser, Basel
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Online ISBN: 978-3-7643-8362-6
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