Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.

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Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:

1. As of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.

2. Clinical trials that begin enrolling participants on or after January 1, 2019, must 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. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

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). Illustrative examples of data sharing statements that would meet these requirements are in the Table.

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