Darren B. Taichman et al. have published "Data Sharing Statements for Clinical Trials—A Requirement of the International Committee of Medical Journal Editors" in PLOS Medicine.
Here's an excerpt:
Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:
- 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.
- 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.
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