Center for Global Research Data

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December 14, 2018 | Using Vivli to Meet NIH Data Sharing Plan Requirements

Ida Sim, Technical Lead, Vivli

As increasing numbers of funders introduce requirements for data sharing plans, researchers have to develop a new skill: how to create and fulfill a data sharing plan.

Many data sharing plan requirements from funders have similar requirements. While the specifics vary somewhat based upon the type of data and how the researcher plans to share clinical data once it is completed, the general questions to ask about data sharing mandates are:

  • WHO do these requirements apply to?
  • WHAT data do you plan to share, and in what format?
  • WHEN will it be made available, and for how long?
  • WHERE will it be accessible?
  • HOW can it be accessed, i.e. under what conditions or restrictions?

Vivli is an innovative new clinical research data sharing platform with a robust search engine that has been created to meet the needs of researchers who use clinical research data worldwide. Using the Vivli platform, researchers can access de-identified data from thousands of completed clinical trials. However, Vivli also has another benefit to researchers: providing them an easy, straightforward means of meeting their data sharing requirements. Unlike many data repositories or registries, Vivli offers a tool for safely sharing individual-level participant data (IPD), rather than just summary results. This helps clinical researchers meet their data sharing requirements from key funders, such as the NIH. For an example of how a researcher could use Vivli to meet NIH requirements, see the chart below:

NIH Requirements How can Vivli help?
Who? Investigators submitting a research application requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003 are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible. Vivli can help researchers meet their NIH data sharing requirements.

Learn more about sharing data on Vivli here.

What? The precise content of the data-sharing plan will vary [but may include]:

  • the format of the final dataset,
  • the documentation to be provided,
  • whether or not any analytic tools also will be provided.
As a neutral platform, Vivli lets data contributors decide which data to share.

  • You can securely share individual de-identified participant data on Vivli.
  • Vivli also allows researchers to store and share study related documents, code and tools.
When? Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing.
  • Vivli will store data and make it available for as long as it retains scientific utility.
  • Once you upload your data in a simple drag-and-drop process, it is made available for sharing.
Where? The NIH allows researchers to choose the mode of data sharing, including repositories like Vivli.
  • On the Vivli platform, your data is accessible to everyone globally increasing the visibility and impact of your data.
  • Vivli will manage all requests for your data directly, reducing the administrative burden of data sharing.
How? Applicants who are planning to share data may wish to describe briefly:

  • whether or not a data-sharing agreement will be required
  • a brief description of such an agreement
  • the criteria for deciding who can receive the data whether or not any conditions will be placed on their use
Vivli can make it possible for your data to be downloadable or can be accessible in a secure research environment.

  • All data shared on Vivli is subject to a Data Use Agreement.
  • The conditions of sharing are made transparent on the Vivli website.

Data sharing plans may be included in the grant proposal. Under Vivli Resources on our website, we have created an NIH Data Sharing Template  to help you meet data sharing requirements. If you have any questions about this blog, or how to use Vivli to meet data sharing requirements, please contact the Vivli team via email to support@vivli.org.