Established on January 2, 2004
Most recently revised on January 8, 2018
Table 1. Examples of data sharing statements that fulfill 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 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 at 3 months and ending at 5 years following article publication. | Beginning at 9 months and ending at 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.