Share Your Data on the Vivli Platform

 

share data

 

Sharing the data from your completed clinical research helps advance scientific knowledge, is what many trial participants want and expect (as long as there are the appropriate safeguards), and more and more funders are mandating data sharing. Vivli as an organization works to support researchers to share and make it as easy as possible. The key questions and processes are outlined below. If you still have questions, fill out the form at the bottom of the page and the Vivli team will be happy to support you. Please note that this process is primarily intended for academic researchers. Please reach out to Vivli, if you are from forprofit organization and want to take advantage of the Vivli platform to share your completed clinical research data.

Why share your data using Vivli?

  • Ease of sharing – Vivli makes it easy for you to meet your data sharing commitments to funders as well as journals and above all to the trial participants.
  • Metrics report of data use – Vivli will provide, upon request, a report detailing how your data has been used in secondary publications – data you may use in future grant applications.
  • Funders are increasingly mandating data sharing. The Bill & Melinda Gates Foundation, Wellcome Trust and many others are requiring that Individual Patient-Level Data from research they fund is shared. In addition, the updated NIH Data Sharing Policy which went effect in January 2023. (Further guidance on how to complete an NIH Data Management and Sharing Plan using Vivli is available under our resources section.) For many funders, data sharing costs are an allowable research expense and may be built into future grant proposals and billed to current grants.
  • Top journals such as the NEJM, BMJ, Lancet and other ICMJE journals require that the data sharing statement is made at the time of trial registration. Journals are publishing the data sharing statement at the time of publication. (Further guidance on how to use Vivli to meet publication, particularly ICMJE publication data sharing requirements is available under our resources section
  • Moral obligations (owe it to trial participants). We owe it to participants of clinical trials who have volunteered to take part in this research for their data to be leveraged to maximize scientific knowledge. Surveys show that most participants want their data to be shared if adequate safeguards are in place.
  • Increase citations. Sharing detailed clinical research data is associated with increased citation rate.

Steps to sharing your clinical research data on Vivli

 

  • Vivli is here to make it as efficient and easy as possible to share your anonymized human-subject participant level data and supporting documents. The Vivli team will support you every step of the way.
  • Once you have created your Vivli account, you will be prompted to provide information about your study.
  • The Vivli Data Contribution Agreement needs to be read, understood and signed by the Principal Investigator and an institution official.
  • Vivli only accepts anonymized data. Your institution may provide support or Vivli has anonymization vendors who will offer support for this service.
  • Once the submission has been accepted by the Vivli team, you will then be able to upload your anonymized data.
  • Please note that the process outlined above is primarily intended for academic researchers. Please reach out to
    Vivli
    , if you are a forprofit organization and want to take advantage of the Vivli platform to share
    your completed clinical research data.

For more information, see our step-by-step Study Submission guidance.

Researcher Data Sharing Costs

If your academic institution is a member of Vivli there is no cost to deposit data in Vivli’s platform starting in 2023.
Please check our members, if you are unsure of the status of your institution. More information is available about the benefits for academic institutions to join as a member.

If your academic institution is not a member, there is a one-time cost to use Vivli’s managed access process for clinical research data. These costs apply only for academic and non-profit researchers who want to share their clinical data. For industry, please complete a member form and we will reach out to you directly to discuss your needs.

Services include initial consult, metadata curation, archiving for 10 years securely in the cloud, data persistent identifier (DOI) provided for primary publications and to meet grant commitments.

If researchers need assistance to anonymize their data, Vivli can connect researchers to our specialist anonymization partners.

2024 PricingCost
Clinical trial dataset (<100GB)$2,500 USD
Clinical trial dataset (<500GB)$4,000 USD
Clinical trial dataset (500GB-2T)$10,000 USD
Clinical trial datasets (2T-4T).$16,000USD
>4TEmail support@vivli.org for options
Anonymization fee (Optional)$10,000 USD

What do I need to include as part of my data package?

Data package – Protocol, anonymized individual participant-level dataset, data dictionary, and statistical analysis plan are recommended; additional elements such as an annotated case report forms, clinical study report, and analysis ready datasets can also be included. This video explains what is typically included as part of a data package and how you can make it more useable for future research.

What is the review process for subsequent requests to access and reuse my data?

When a research team requests your study, an Accelerated Research Proposal Review will be conducted within 3 business days. Vivli will manage the execution of the Data Use Agreement. Once these steps are completed, the Vivli team will work with the researcher to access the data and support them until they have published their results.

Guidance for Researchers on preparing a DMSP and sharing NIH-Funded data

The NIH has updated its policies on data management and sharing (DMS). Effective January 25, 2023, the NIH DMS policy applies to most research funding by the NIH, and requires all applicants planning to generate scientific data to prepare a DMS Plan (DMSP) that describes how they will manage and share data.

An effective DMSP requires thoughtful planning, preparation, and execution. We’ve compiled information and resources here to support every step of the process.

How to prepare a DMSP

The DMSP is a set of principles and guidelines that outline requirements for sharing data generated by NIH-funded research. It includes six major elements:

  1. A description of the data type
  2. Related tools, software, and/or code
  3. Common data standard that will be applied to the data
  4. Information about data preservation, access, and associated timelines
  5. Factors affecting access, distribution, or reuse of data
  6. Overview of how compliance with plans for management and sharing will be managed

The DMSP should also include information about direct costs required to support the activities outlined in the Plan.

Vivli has a step-by-step guide to understanding each of these elements and items to consider when developing a DMSP. We also have a customizable DMSP exemplary language available for download and adaptation, which includes sample text as well as guidance on preparing and submitting a budget as part of the DMSP.

Fill out the form below to access all the DMPS Guidance provided by Vivli.

    What best describes your current role?

    Do you plan to include Vivli in any future data management plans?

    How to choose the right repository to share your dataTo enable the implementation of the updated DMS policy, NIH has supported the establishment of the Generalist Repository Ecosystem Initiative (GREI). GREI is a collaboration of seven established generalist repositories who are working together to develop consistent standards and processes to facilitate sharing and reuse of data from NIH-funded studies. As part of preparing a DMSP, researchers will have the opportunity to review repository options and choose the one that best aligns with their needs. Vivli is part of the GREI initiative. The Vivli platform is the only GREI repository that focuses on sharing completed clinical research data at the individual participant level. To assist in considering these options, NIH has prepared guidance on selecting a data repository.

     

    If you or your organization has clinical research data to share, and has further question please get in touch with us by filling out the form below and we will respond shortly.

      Is the trial registered on CT.GOV or another registry? Please provide the identifier

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