The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meaning that they transmit the necessary information accurately, transparently, and clearly to the target audience (usually reviewers at the health agencies but readers might also be investigators or members of ethics committees).
In the Internet era, regulatory writers have instant and complete access to almost all the necessary guidelines governing these documents (and Raquel Billiones has gone to the trouble of compiling these guidelines; see p84). Yet there is actually rather little information in the public domain on how these guidelines should be applied and interpreted in practice. Some books are available on medical writing, but these have relatively little if anything to say about regulatory writing and focus on research articles and other aspects of medical communications. A quick search on the Amazon website revealed one book dedicated to regulatory writing.1 The book was published in 2008, but guidance changes and clarifications are issued in the form of Questions and Answers documents to address contradictory or ambiguous aspects of the guidance.2 So while the core skills needed for regulatory writing remain fairly constant, the details may change and the regulatory environment evolves.
This issue of Medical Writing, entitled Regulatory writing basics, is an attempt to fill, at least partially, the void of information on the subject and provide a useful reference guide for regulatory writers. (Here, I feel compelled to acknowledge that the original idea for this issue did not come from me but rather from Phil Leventhal, the regular Medical Writing editor). Regulatory writing is a wide field and so the scope of the articles has been limited to the types of document that an entry level regulatory writer is likely to encounter. It is also limited to pre-approval documents associated with drug development. The December 2014 issue of Medical Writing will be dedicated to the topic of post-approval.
At some point early in their careers, most entry-level regulatory writers work will work on a Clinical Study Report (CSR), which is covered in depth by Sam Hamilton (p86). For the most part, the guidelines covering the CSR are detailed and well developed, although they have occasionally been interpreted too literally. For example, the table of contents of the guidelines was interpreted by many companies as a template for their CSRs, resulting in the somewhat absurd situation of having the title page of the CSR listed as Section 1. This is a good example of the pitfalls of unthinking and rather slavish application of guidelines and also, I think, the desire of many companies to be as compliant as possible with the perceived letter of the guidelines while perhaps losing sight of their intent. A necessary skill of a regulatory writer is knowing when to treat guidance as set in stone and when it is appropriate to deviate from the letter of the guidance to ensure clarity and readability.
The Protocol is another document that writers may be involved in at some point in their careers. As Walther Seiler explains though (see p93), despite its obvious importance, the far-from