Thread: Knowledge Updates

Clinical documentation — from preclinical studies to drug registration

Greg Morley – Madrid, Spain

From the moment a promising discovery is made in the laboratory to when a new drug finally appears on the market, many years will have passed, plenty of money will have been spent, and a bewildering range of documents will have been drafted, edited, and at times translated. Some documents, such as patient information sheets for clinical trials, must be written such that they are readily understood by lay people whereas others, such as clinical study protocols and reports, can have a more specialized register. All these different elements place specific demands on the job of editor, translator, and writer that necessitate a familiarity with terminology, style, and content. In this presentation, I shall provide an overview of the purposes of these documents, how they are drafted and the terminology they use. Participants will become familiar with the main types of clinical documentation and will be provided with sources of more detailed information that will help them to improve their skills or enter this complex area.

After a short career as a bench scientist, Greg Morley has been working as medical writer, translator and editor for more than 10 years. Currently a freelancer based in Madrid, his experience in the pharmaceutical industry includes writing patents for SmithKline Beecham and writing regulatory documents in a small contract research organization. Website: www.docuservicio.com.