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

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.