News & Events

 NIH’s New Data Sharing Policy: Maximizing the Value of Research through Data Re-use and Data Access on the Vivli Repository

Learn how the Vivli repository is making it easier for scientists to share and access data, and how you can comply with the NIH’s data management and sharing policy (DMSP) to maximize the value of your research

The National Institutes of Health (NIH) has a policy in place to ensure that data generated by NIH-funded research is accessible to the scientific community starting on January 25, 2023.

Data should be made available as soon as possible or the acceptance for publication of the main findings from the final dataset but the latest date is the end of the award. Data sharing can be done through a variety of mechanisms, including NIH domain repositories or NIH generalist repositories. These can be open-access or controlled-access systems. One such controlled-access repository recognized by the NIH is Vivli, a generalist repository for sharing of clinical data for human research studies.

As a condition of their grant application, investigators are now required to prospectively plan for management of their data and preparing it for re-use, submit a data management and sharing plan (DMSP), and comply with the drafted plan. The NIH Data Sharing Policy (DSMP) encourages investigators to share their data in order to maximize the value of NIH research funds.  But what exactly is a DMSP and how do you draft one for submission to the Vivli Repository? The DMSP is a set of principles and guidelines that outline the requirements for sharing data generated by NIH-funded research. It includes 6 major elements that were selected to ensure that the data is shared as widely and promptly as possible, to maximize the scientific and public health value of the research, while protecting participant privacy and confidentiality. To fill out the DMSP, decisions should be made about the choice of repository, how long the repository will hold/archive the data, whether special tools/software will be provided to access the data, whether consensus data standards apply or exist, whether controlled access will be required and the oversight management details.

To help investigators on their journey to fulfilling the NIH data sharing policy, we have created a list of all the other resources available on our website, including the DMSP template guidance and budget guidance specific to using Vivli to help you navigate the process. 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.

Vivli has recently released new features timed to the NIH policy launch including: branded portals for research programs / institutions; academic credit; streamlined process for data sharing and reporting for institutions.

In summary, the NIH encourages data sharing as part of its mission to advance biomedical research and to promote collaboration among scientists. Vivli is a non-profit organization that provides a platform recognized by the NIH for funded researchers to share and access anonymized clinical trial data in a secure and compliant way.

    What best describes your current role?

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

     

    Share NIH-Funded Data

    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 DMSP 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 data

      To 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.

      Once your grant is approved – what next?

      How to submit studies to Vivli for data sharing

      If you’ve decided that Vivli is the right repository for your study data, great! We’ve developed a straightforward and efficient submission process, and we’ve got detailed guidance on how to submit your data and a checklist when you’re ready to begin the process to share your data.

      ResourceDescription
      Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
      Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload

      Further questions?

      Email Vivli at support@vivli.org and we will be delighted to assist you.

       

      Submitting Your NIH Data Management and Sharing Plan using Vivli

      The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.

      Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).

      During this webinar, we:

      • Provide an overview of Vivli, including what types of data should be shared in Vivli
      • Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
      • Review the steps to completing the NIH DMSP and budget justification
      • Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP

      Speakers include:

      • Anne Seymour, Johns Hopkins University
      • Amy Nurnberger, Massachusetts Institute of Technology
      • John Borghi, Stanford University
      • Rebecca Li and Julie Wood, Vivli

      Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.

      View Recording

      Public Disclosures

      These tables provide details of approved research proposals that have published or presented their results.

      Projects at Vivli

      Vivli works with many partners and funders to further its vision to advance human health through clinical research data sharing, to respect and honor the contributions of clinical research participants.

      How to Guides

      Vivli provides the following resources to assist users of the Vivli Platform:

      Data Request Guidance and Support

      ResourceDescription
      Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit a request for study data.Download PDF
      Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
      Vivli How To – Requesting StudiesHow to request studies through the Vivli platform.Download PDF
      Vivli Data Request Quick Start (Video)A 3-minute video showing how to submit a data request.Watch video
      Vivli Platform demo – How to search, request, and analyze data on VivliA short video showing how to request data on VivliWatch video
      Vivli Lay Summary Training VideoHints and tips for completing your Vivli Lay Summary as part of your data request.Watch video

      Download PDF
      Vivli Data Request Form WorksheetWorksheet of information needed to complete a Vivli data requestDownload
      Vivli Data Request Form Tips and TricksHints and tips for completing your Vivli Data Request Form.Download PDF
      Data Request Form SampleExample of fully completed Data Request FormDownload PDF
      Vivli Policies in BriefSynopsis of key policies governing interactions between researchers and data contributors during the lifecycle of a research proposal.Download PDF
      Software and R Packages Available in the Research EnvironmentAnalytical and other software available in the research environmentDownload PDF

      Study Submission Guidance and Support

      ResourceDescription
      Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit your study.Download PDF
      Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
      Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
      Vivli How To – Study submissionData sharing instructional videoWatch Video
      Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload
      ICMJE Data Sharing RequirementsHow to use Vivli to meet ICMJE data sharing requirementsDownload PDF

      NIH DMSP Guidance

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

        What best describes your current role?

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

         

        Vivli Metrics

        metricsVivli aims to advance human health through clinical research data sharing. One of the key ways we support this is through the Vivli platform, which facilitates data sharing. Vivli platform metrics as of 26 April 2024. The metrics will be updated every two months. 

        Webinars, Publications & Presentations about Data Sharing

        VIVLI WEBINARS

        View Vivli’s webinars at your convenience by clicking on the links below:

        DateWebinarSpeakers
        April 2024The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of ConcernRebecca Li, Vivli
        David Peloquin, Ropes & Gray
        April 2023Recent Developments in Data Privacy Laws and their Impact on Data SharingRebecca Li, Vivli
        David Peloquin, Ropes & Gray
        Katherine Wang, Ropes & Gray
        February 2023Submitting Your NIH Data Management and Sharing Plan using VivliAnne Seymour, Johns Hopkins University
        Amy Nurnberger, Massachusetts Institute of Technology
        John Borghi, Stanford University
        Rebecca Li and Julie Wood, Vivli
        November 2022Applying the SAFE Data Standard to Securely Share Clinical Trial DataLuk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
        Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
        Aaron Mann, CEO, Clinical Research Data Sharing Alliance

        Moderated by:
        Marcia Levenstein, Senior Advisor, Vivli
        October 2022Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologiesLuk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
        Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB

        Moderated by:
        Aaron Mann, CRDSA CEO
        June 2022How Vivli Promotes Discoverability of Partner Platforms and RepositoriesIshwar Chandramouliswaran, NIH
        Dawei Lin, ImmPORT
        Ida Sim, UCSF and Vivli
        June 2021Sharing Academic Clinical Research DataIda Sim, UCSF and Vivli
        Dan Ford, Johns Hopkins University
        Susanna Naggie, Duke University
        Kim Serpico, Harvard T.H. Chan School of Public Health
        Ara Tahmassian, Harvard University
        March 2021Clinical Trial Data Sharing and Machine Learning ResearchIda Sim, UCSF and Vivli
        Abigail Gregor, Ropes & Gray
        Daniel Freshman, Ropes & Gray
        September 2020Synthetic Data: How to preserve privacy of participants when sharing clinical dataPatrick Cullinan, Bluebird Bio
        Khaled El Emam, Replica Analytics
        Michael Lesh, Syntegra
        July 2020Accelerating Science in the Age of COVID-19: Three Key Data InitiativesRebecca Li, Vivli
        Elizabeth L. Ogburn, Dr. Barbara Bierer, COVID Collaboration Platform
        Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc
        April 2020 Data Sharing and Data Anonymization: the Vivli-Privacy Analytics Partnership Rebecca Li
        Niamh McGuinness
        February 2020Future Directions: Real World Data, Real World Evidence and Clinical TrialsDr. Ida Sim
        Marcia Levenstein
        Dr. Gregory Pappas
        Dr. Jack Mardekian
        November 2019Credit for Data SharingDr. Barbara Bierer,
        Ms. Heather Pierce
        October 2019Why Data Sharing and Data Standardization MattersMr. David Bobbitt MSc, MBA
        Dr. Ida Sim, MD, PhD
        Dr. Rebecca Li
        May 2019Top five questions small and mid-size companies should ask before embarking on a data sharing programDr. Rebecca Li
        March 2019 Keys to Submitting a Quality Research Proposal to a Data Sharing PlatformMs. Cynthia Holas,
        Dr. Sonali Kochhar,
        Dr. Georgina Humphreys,
        Dr. Joe Ross,
        Ms. Ginger Gamble, MPH.

        February 2019 Informed Consent and Data Sharing Dr. Barbara Bierer ,
        Dr. Rebecca Li ,
        Mr. David Peloquin,
        Dr. Stephen Rosenfeld
        January 2019How to Share and Request Data on VivliDr. Ida Sim, MD, PhD
        November 2018 IPD Meta-Analysis Webinar Dr. Sarah Nevitt

        PUBLICATIONS ABOUT DATA SHARING

        Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse

        Rebecca Li, Nina Hill, Catherine D’Arcy, Amrutha Baskaran, Patricia Bradford, "Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse", Health Data Science, vol. 2022, Article ID 9768384, 3 pages, 2022
        COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic

        Kristina Larson, Ida Sim, Megan von Isenburg, Marcia Levenstein, Frank Rockhold, Stan Neumann, Catherine D'Arcy, Elizabeth Graham, David Zuckerman, Rebecca Li. COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic. Contemporary Clinical Trials. 2022.

        Sharing Health Data: The Why, the Will, and the Way Forward A Special Publication from the National Academy of Medicine

        Whicher, D., M. Ahmed, S. Siddiqi, I. Adams, M. Zirkle, C. Grossmann, and K. L. Carman, Editors. 2021. Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. NAM Special Publication.Washington, DC: National Academy of Medicine.

        New NonProfit Aims To Bring Data Transparency To Researchers
        Move clinical trial data sharing from an option to an imperative
        Timely access to trial data in the context of a pandemic: the time is now.

        Li R, Wood J, Baskaran A, et al. Timely access to trial data in the context of a pandemic: the time is now. BMJ Open 2020; 10:e039326. doi: 10.1136/bmjopen-2020-039326
        COVID-19 trials: declarations of data sharing intentions at trial registration and at publication

        Li, R., von Isenburg, M., Levenstein, M. et al. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials 22, 153 (2021). https://doi.org/10.1186/s13063-021-05104-z
        Data Sharing Goals for Nonprofit Funders of Clinical Trials

        Coetzee T, Ball M, Boutin M, Bronson A, Dexter DT, English RA, Furlong P, Goodman AD, Grossman C, Hernandez AF, Hinners JE, Hudson L, Kennedy A, Marchisotto MJ, Myers E, Nowell WB, Nosek BA, Sherer T, Shore C, Sim I, Smolensky L, Williams C, Wood J, Terry SF, Matrisian L
        Data Sharing Goals for Nonprofit Funders of Clinical Trials J Particip Med 2021;13(1):e23011 doi: 10.2196/23011 PMID: 33779573

        PRESENTATIONS

        May 10-11, 2021"Considerations for Sponsors when using a Data Sharing Platform" and panel, "Balancing Sharing Results and Data Whilst Protecting Participants Data Privacy" at InformaConnect Clinical Data Disclosure, Transparency & Plain Language SummariesJulie Wood
        Rebecca Li, PhD
        May 5, 2021"Data Sharing in a Time of Pandemic", a webinar with Front Line GenomicsRebecca Li, PhD
        April 12, 2021"Implementation of Data Sharing platforms and How Researchers are Utilizing these Platforms to Further their Research.", a webinar with the HRB-Trials Methodology Research NetworkRebecca Li, PhD
        March 26, 2021"Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit SeriesIda Sim, MD, PhD
        January 19, 2021"Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter MeetingRebecca Li, PhD
        December 11, 2020 "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinarIda Sim, MD, PhD
        November 6, 2020"Responsible Data-Sharing to Improve Research Integrity." European Medical Writers Association 2020 Virtual Symposium Julie Wood
        October 16, 2020"Privacy Incoherence in Medicines: The Confluence of Corporate Trade Secret, Government Non-Transparency, and AI Mediated Erosion of Patient Privacy." Northeastern University's Center for Law, Innovation and Creativity Annual ConferenceRebecca Li, PhD
        August 18, 2020"Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health PolicyRebecca Li, PhD
        April 24, 2020"Sharing, Discovering and Citing COVID-19 Data and Code." National Library of Medicine (NLM) at the National Institutes of Health (NIH)
        Ida Sim, MD, PhD
        February 11, 2020"Vivli Clinical Research Data Sharing: Share. Discover. Innovate." NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, Bethesda MD
        Ida Sim, MD, PhD
        October 25, 2019 “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon."DIA Future of Evidence WorkshopRebecca Li, PhD
        October 10, 2019 "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium WebinarIda Sim, MD, PhD
        Rebecca Li, PhD
        September 27 2019 "Preparing for clinical trial data sharing and re-use: the new reality for researchers." NIH Collaboratory Grand RoundsRebecca Li, PhD
        Frank Rockhold, PhD
        September 19, 2019“The Vivli Experience in Sharing Clinical Trial Data Globally.”OHRP Exploratory Workshop: Privacy & Health Research in a Data-Driven WorldRebecca Li, PhD
        June 2019“Symposium SY13: Data sharing and responsible conduct of research: sharing industry experiences as part of the research transparency environment."World Conference in Research Integrity, Hong KongRebecca Li, PhD
        March 27, 2019“Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
        January 30, 2019“The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PAJulie Wood
        Thomas Wicks (TrialScope)
        October 25, 2018 "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, LondonRebecca Li, PhD
        March 13, 2018“Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” American Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
        November 17, 2017 “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TXIda Sim, MD, PhD