Using Vivli to Meet ICMJE Data Sharing Requirements
In June of 2017, the International Committee of Medical Journal Editors, or ICMJE, released new requirements for data sharing statements, for submissions to their publications. The ICMJE represents the most well-respected and influential publications in the biosciences, including the New England Journal of Medicine; the Lancet; Annals of Internal Medicine; the BMJ; and PLOS Medicine: These publications now require the inclusion of a data sharing statement in all submissions for publication. ICMJE publication editors may take these statements into consideration when making editorial decisions.
As of 1 January 2019, ICMJE requires inclusion of your data sharing statement at the time of trial registration. In their guidance to researchers, the ICMJE notes that when it comes to data sharing, “undecided is not an acceptable answer.” Rather than remaining “undecided,” see the chart below to learn how to use Vivli in completing your ICMJE data sharing statement.
|ICMJE Question||How to respond, if using Vivli to share your data:|
|Will IPD (and data dictionaries) be made available?||Yes.|
|What data in particular, will be shared?||Final cleaned individual participant-level data, de-identified *
|What other documents will be made available?||Final protocol, statistical analysis plan, and the data dictionary. (Note: additional documents such as CRFs and analytic code may also be included.)|
|When will data be made available and with whom?||Data will be made available X months / years after study completion.* Data is available to anyone with the relevant skill set to conduct the analysis, who has submitted an approved proposal on vivli.org.|
|For what types of analysis?||To achieve the aims and objectives in the scientific proposal as approved via Vivli.|
|By what mechanism will data be made available?||Following an approved request, a data use agreement must be signed.
Data are made available via a secure research environment or download.
*It is up to the researcher to decide when after the study completion the data will be shared.
For more information or assistance in using Vivli to meet data sharing requirements, email email@example.com.