B – Guidance for submission of raw clinical data for publication

Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ 2010;340:c181. http://www.bmj.com/cgi/content/full/340/jan28_1/c181

Many journals and funding bodies require researchers to make their raw data available, but there is a need for guidance on data sharing in clinical medicine. For any data relating to individuals, risks to patient confidentiality and anonymity should be minimised, and, where possible, consent should be sought from participants. Direct identifiers should not be included in the data, and if three or more indirect identifiers (e.g., age, sex) are included, the data should be reviewed by an independent researcher or ethics committee before submission for publication.