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, and the many others which follow their lead, 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. Researchers should also know that 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.” When pre-registering interventional trials on clinicaltrials.gov, if “Undecided” is selected for the “Plan to Share IPD” data element, a note now appears indicating that the ICMJE data sharing policy requires a “Yes” or “No” answer to this question. The “Plan to Share IPD” data element is optional on CT.gov, but is required by the ICMJE as part of registration information for interventional studies 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?||X months /years after study completion|
|With whom?||Anyone with the relevant skillsets to conduct the analysis, who submitted an approved proposal on Vivli.
Proposals are submitted 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.|
For more information or assistance in using Vivli to meet data sharing requirements, email firstname.lastname@example.org.