DATA SHARING statement by ICMJE

ICMJE statement on data sharing, published June 5, 2017, in the ICMJE journals stats that:

  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...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 de-identified 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)... Sharing clinical trial data is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing.

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

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