Templates and style guides: The nuts and bolts of regulatory documents

  • James Yuen
  • Debra L. Rood


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.


Regulatory Document Arabic Numeral Regulatory Submission Clinical Study Report Document Template 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    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.pdf. Accessed 27 February 2008.
  2. 2.
    Foote MA, Hecker S, Style — what it is and how to get it. DIA Forum 2003; 39: 32–35.Google Scholar
  3. 3.
    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.

Copyright information

© Birkhäuser Verlag Basel/Switzerland 2009

Authors and Affiliations

  • James Yuen
    • 1
  • Debra L. Rood
    • 2
  1. 1.MoorparkUSA
  2. 2.Liquent Certified Advanced PublisherSimi ValleyUSA

Personalised recommendations