Where necessary, we encourage authors to share data to support the publication of studies and to interlink data with their published articles. “Research data” refers to the results of observations or experiments that confirm research findings, including but not limited to raw data, processed data, software, algorithms, protocols, models, methods, and other related materials.
In following this policy, if authors have made their study data accessible in a data repository, they can link their articles directly to the dataset.
Specifically, authors are required to fill in a data-sharing statement form, which should be submitted along with their manuscript. If the article is accepted for publication, the Data Availability Statement will be published (online only) alongside the article. Data sharing statements include information regarding whether individual de-identified participant data (including data dictionaries) will be shared (n.b. “undecided” is not an acceptable answer) and/or what data in particular will be shared. They may also indicate whether additional related documents will be available (e.g., study protocol or a statistical analysis plan) as well as when and for how long the data will be available and what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).
Meanwhile, as a member of the International Committee of Medical Journal Editors (ICMJE), we require clinical trials that began enrolling participants on or after January 1, 2019, to include a data-sharing plan in the trial's registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Should the data-sharing plan change after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
