Data Sharing Statement for Clinical Trials

Balkan Medical Journal follows ICMJE recommendations. The ICMJE require authors to submit a data-sharing statement for randomized clinical trials. Authors must provide a data-sharing notification to indicate whether data will be shared. According to ICMJE “Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)” (for details: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html). Balkan Medical Journal require authors to submit a data-sharing statement and register a data-sharing plan when registering a clinical trial on or after Jan 1, 2019.