Articles reporting the results of clinical trials must follow the current version of the ICMJE policy on data sharing in the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
Data-sharing statements must indicate the following:
- Whether individual deidentified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer).
- 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).