Clinical Data Sharing Policy
This journal follows the data sharing policy described in “Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors” (https://doi.org/10.3346/jkms.2017.32.7.1051). 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 http://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 shown in Table 1.
Table 1. Examples of data sharing statements that fulfill these ICMJE requirements*
Element
Example 1
Example 2
Example 3
Example 4
Will individual participant data be available (including data dictionaries)?
Yes
Yes
Yes
No
What data in particular will be shared?
All of the individual participant data collected during the trial, after deidentification.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Not available
What other documents will be available?
Study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code
Study protocol, statistical analysis plan, analytic code
Study protocol
Not available
When will data be available (start and end dates)?
Immediately following publication. No end date.
Beginning 3 months and ending 5 years following article publication.
Beginning 9 months and ending 36 months following article publication.
Not applicable
With whom?
Anyone who wishes to access the data.
Researchers who provide a methodologically sound proposal.
Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose.
Not applicable
For what types of analyses?
Any purpose
To achieve aims in the approved proposal.
For individual participant data meta-analysis.
Not applicable
By what mechanism will data be made available?
Data are available indefinitely at (link to be included).
Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement.
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
Not applicable
Data are available for 5 years at a third-party website (link to be included).
Information regarding submitting proposals and accessing data may be found at (link to be provided).
ICMJE = International Committee of Medical Journal Editors.
*These examples are meant to illustrate a range of, but not all, data sharing options.