Data Sharing Statement for Clinical Trials
Balkan Medical Journal follows ICMJE recommendations. The ICMJE require authors to submit a data-sharing statement for randomized clinical trials. Authors must provide a data-sharing notification to indicate whether data will be shared. According to ICMJE “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)” (for details: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html). Balkan Medical Journal require authors to submit a data-sharing statement and register a data-sharing plan when registering a clinical trial on or after Jan 1, 2019.
| Availability of data | Template for data-sharing statement |
| Data openly available in a public repository that issues datasets with DOIs | The data that support the findings of this study are openly available in [repository name e.g “figshare”] at http://doi.org/[doi], reference number [reference number]. |
| Data openly available in a public repository that does not issue DOIs | The data that support the findings of this study are openly available in [repository name] at [URL], reference number [reference number]. |
| Data derived from public domain resources | The data that support the findings of this study are available in [repository name] at [URL/DOI], reference number [reference number]. These data were derived from the following resources available in the public domain: [list resources and URLs] |
| Embargo on data due to commercial restrictions | The data that support the findings will be available in [repository name] at [URL / DOI link] following an embargo from the date of publication to allow for commercialization of research findings. |
| Data available on request due to privacy/ethical restrictions | The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. |
| Data subject to third party restrictions | The data that support the findings of this study are available from [third party]. Restrictions apply to the availability of these data, which were used under license for this study. Data are available [from the authors / at URL] with the permission of [third party]. |
| Data available on request from the authors | The data that support the findings of this study are available from the corresponding author upon reasonable request. |
| Data sharing not applicable – no new data generated | Data sharing is not applicable to this article as no new data were created or analyzed in this study. |
| Author elects to not share data | Research data are not shared. |
| Data available in article supplementary material | The data that supports the findings of this study are available in the supplementary material of this article. |
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