B - Preparing clinical data for publication

Hrynaszkiewicz I, Norton ML, Vickers AJ, et al. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Trials 2010;11:28. doi:10.1186/1745-6215-11-9

Many journals require authors to make their raw, unprocessed data available to other scientists, but there is little information on how this data should be prepared for publication and sharing. In clinical research patient privacy and consent for use of personal health information are key considerations, but there are no agreed-upon definitions of anonymised patient information. In this article, the authors propose a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biomedical journal, or for sharing with other researchers. Basic advice on file preparation is provided along with procedural guidance on prospective and retrospective publication of raw data, with an emphasis on randomised controlled trials.