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.

       

      Public Disclosures

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

      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 June 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

        Enquiries about Vivli Member Studies

        To enquire about a study not listed on Vivli or to obtain additional information not included in a study listing, please submit an enquiry through the Vivli Platform. To submit an enquiry or request access to study data, you will need to create a Vivli Platform account. Additional information on how to get started is available in our guide to requesting studies on Vivli.

        For more information on Vivli Members, please visit the Member Page. Some Members may require that enquiries be submitted via their own portals. Enquiries will be answered at the discretion of the Member. Please note that most members do not share studies where the primary completion date has not yet been reached.

        Have a question and need to get in touch with the Vivli team? Contact us.

         

        Our Members

        Please click on the logo of each member to find out more about how they work with Vivli. This includes a summary of their policies, approaches and procedures.

        FAQs

        Please see below for frequently asked questions regarding Vivli, including the general features of the Vivli Platform. For more specific questions, including any questions regarding a specific data request, please review the Vivli resources section for more detailed guidance or contact Vivli User Support directly at support@vivli.org.

        Getting started with the Vivli platform

        What license do I need to use to participate in the Vivli platform?

        No license is needed. All users sign a Data Use Agreement specifying terms for use and re-use of the data. The DUA is the product of extensive negotiation with the organizations that contribute data to Vivli, and as such, the agreement is non-negotiable. More than 85 institutions from 25 countries have already signed this agreement.

        Does Vivli comply with the General Data Protection Regulation (GDPR)?

        Yes, Vivli does comply with GDPR. Please see Vivli’s privacy policy.

        What support do you offer users?

        Vivli has a dedicated, responsive support team available to answer any questions and help you through the process of submitting or requesting data. At any time, you may contact the Vivli support team at support@vivli.org. We aim to reply within 1-2 business days. For additional information about Vivli support options, check out our blog post on the topic: How our team supports users on the Vivli platform.

        My organization is interested in becoming a member. How do I do that?

        We’re delighted you’re interested in becoming an institutional member of Vivli. Learn more information about how to become a member here.

        You do not have to be a member to request data using the Vivli platform. You can also share the data from your clinical research. You find out more about that by going to How to share data.

        How do I create an account and log in to the Vivli platform?

        Logging into the Vivli platform is easy! Check out our quick start guide to help you through the process.

        What are benefits of data sharing?

        • Funders are increasingly mandating data sharing. The 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 went into effect January 2023. For many funders, data sharing costs are an allowable research expense and maybe 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.
        • 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.

        What is the Vivli platform and how is it unique?

        Vivli is an independent non-profit organization launched in 2016. Vivli evolved from a project of The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) to enhance access to clinical trials data by promoting data sharing and transparency. In 2013, the MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design, and launch an innovative platform solution for global clinical trial data sharing.

        Vivli’s mission is to promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise. Vivli serves to meet the needs of researchers in all parts of the clinical research ecosystem. For those requesting data, Vivli provides managed access to data from completed clinical trials around the globe and facilitates the ability to integrate data from existing platforms and data repositories. For those seeking to contribute data, Vivli provides a secure, flexible, and user-friendly platform to facilitate sharing clinical trial data with the research community.

        The Vivli platform provides access to anonymized individual participant-level data (IPD) or the raw data that is collected during a clinical trial. The clinical trials represented in Vivli are global and contributed by a diverse group of data contributors. By serving as a global trusted platform, Vivli increases the discoverability of available data in the wider research ecosystem, and increases the overall capacity worldwide for effective data sharing, aggregation, re-use, and novel analysis of valuable clinical research data to advance science and improve public health. The Vivli platform is a cloud-based platform that consists of a dynamic search engine, a data repository, and a secure research environment.

        For more information about Vivli and the Vivli platform, please visit our About page.

        What types of data are currently available through the Vivli platform?

        Vivli features data from completed interventional studies in a number of therapeutic areas for which anonymized Individual Participant-level Data (IPD) are available as well as data from observational studies.

        Requesting access to data

        What kind of requests are accepted on the Vivli platform?

        The purpose of the Vivli platform is to support research utilizing available clinical data leading to published analysis of a concrete scientific hypothesis. For more information about our members’ data sharing policies, please visit each member’s page on our website.

        How do I access data available in the Vivli platform?

        Users either can access the data by downloading it or have access to a remote desktop workspace in a secure virtual research environment. On the member’s page, a member will share if the data is available by download or within the research environment. Find out more about the secure research environment.

        Once I’ve submitted a data request, how long will it be before my request is approved and I have access?

        On average it takes a few months to access data in the Vivli platform, but the timeline will vary depending on the number of data contributors, the number of studies, and your availability to respond to comments. Learn more about the data request process here. Once the proposal is final, the Vivli member(s) will prepare the data for sharing and then upload data to the platform. Additionally, you may find it helpful to review our blog post: 10 tips and tricks for drafting a successful data request.

        Can I access studies not listed on the Vivli platform?

        To enquire about a study not listed on Vivli or to obtain additional information not included in a study listing, please submit an enquiry through the Vivli Platform. To submit an enquiry or request access to study data, you will need to create a Vivli Platform account. Additional information on how to get started is available in our guide to requesting studies on Vivli.

        For more information on Vivli Members, please visit the Member Page. Some Members may require that enquiries be submitted via their own portals. Enquiries will be answered at the discretion of the Member. Please note that most members do not share studies where the primary completion date has not yet been reached.

        Have a question and need to get in touch with the Vivli team? Contact us.

        How do I submit a request to access a particular study?

        More information about how to submit a request is available in our quick start guide as well as our how-to guide for requesting studies, found here in our How To Guides.

        How much does it cost to request data on the Vivli platform?

        Vivli is a non-profit entity supported by both data contributors and data requestors who contribute to the administrative costs of running the platform. Requesting data is free and available to everyone. Data requestors who request data that are accessed through the secure research environment are charged a nominal cost for use of the secure research environment after a specified period of time, learn more here about that cost.

        How can I find studies on the Vivli platform?

        The Vivli platform allows users to search through listed studies using three search methods:

        • PICO Search,
        • Keyword Search,
        • Quick Study Look-up

        For more information, see Searching for Studies on our website.

        Who can use the platform and request data?

        The search feature is open to all users. To request data, a researcher or team must first create an account on Vivli and submit a research proposal. You do not have to be a member to request data using Vivli.

        Please see our quick start guide on how to request data.

        What tools and software does Vivli provide for data analysis?

        As a Vivli user, you have access to a secure research environment, a virtual work-space within the Vivli platform, which contains a bevy of the most popular tools for statistical analysis and manuscript preparation, including SAS, STATA, R, Python, Jupyter, the Microsoft Office suite and a full set of tools and scripts (available on Secure Research Environment page linked above). If your preferred tools are not included in the standard set, the Vivli team may be able to add them for you subject to having the appropriate license and security requirements. Contact support@vivli.org for any questions related to the uploading of additional tools, data and scripts.

        Sharing data on the Vivli platform

        Can I embargo my data set?

        You can upload your data on Vivli before it is shared with others. The study would be listed on Vivli’s platform and would make note of the date when the study data will be available. Researchers can still request the data and it will be shared when the embargo period has ended.

        Can I delete data I contributed to the Vivli platform?

        You may update your data or request that your data is deleted by contacting the Vivli team at support@vivli.org.

        How long will Vivli store my research in the Vivli platform?

        At a minimum, Vivli will make data available for researchers for 10 years, unless they are contractually unable to do so. On an ongoing basis, Vivli evaluates its data holdings with regard to maintaining access and reserves the right to discontinue the distribution of a data collections when deemed appropriate.
        When materials are deaccessioned, the data are no longer publicly accessible at Vivli, although they may still be preserved in Vivli’s storage vault. Because digital files are assigned a persistent digital object identifier (DOI), the study description is still available to view, but is not searchable through Vivli. Web crawlers are instructed to ignore the descriptions (via the robots exclusion protocol).

        For more information about Vivli’s policy, please contact Vivli at support@vivli.org

        Does my data need to be related to a published article?

        No, the data you share does not have to be published. However, the data must be affiliated with completed clinical research. We can meet publication requirements by sharing underlying data.

        What is the maximum file size?

        Vivli data contributors can share files up to 500 MB. Larger sizes of up to 100T can be accommodated. If your file is larger than 1T, please contact Vivli Support at support@vivli.org.

        Does submission to the Vivli platform satisfy publisher requirements for availability of data?

        Yes. The Vivli platform meets ICMJE requirements which includes many of the leading journals. This blog provides sample language for how answer the questions about data sharing as part of the journal requirements.

        How do researchers discover my data in the Vivli platform?

        All data sets are assigned a unique Digital Object Identifier (DOI), which helps make data sets easily discoverable and easy to trace when cited.

        How is data reviewed or curated?

        Vivli offers curation of the study metadata through a process overseen by Cochrane. It also has specialist vendors who can help with anonymization. If you need help with anonymization, contact our support team at support@vivli.org to discuss your options.

        Is data shared on the Vivli platform public or private?

        Vivli offers a secure platform for storing data. The list of studies available via Vivli’s platform is public, however, users must request access to the data for a specific research proposal, and all requests must be approved before access is granted. For more information, see Share Data.

        How much does it cost to share my data on the Vivli platform?

        Learn about the the fee breakdown for sharing your data here: Share Data

        How do I share data on the Vivli platform?

        Learn more and how to share data on the Vivli platform.

        Our team is available to answer any questions you might have about the process (support@vivli.org).

        Who can share data?

        Any individual or group with clinical trial data who has permission to share that data can list studies for sharing on the Vivli platform. All data contributors must sign and conform to the Data Contributor Agreement.  For more information, please contact us at support@vivli.org.

        What kind of studies may data contributors share on Vivli?

        Data contributors may share all completed trials, including phase I-IV interventional studies and observational studies. Additionally, Vivli accepts qualified studies from any investigator, whether funded or sponsored by industry, an academic institution, or non-profit organization.

        Do I need to anonymize my data set prior to contribution to Vivli?

        Yes, Vivli will only host anonymized data in its system. To assist in this process, Vivli partners with d-wise and Privacy Analytics,  industry leaders in health data-sharing methods and technologies, data security and de-identification. Our partners offer anonymization services to individuals and organizations who wish to share clinical research data on the Vivli platform. For more information, contact support@vivli.org.

        What are the specific standardization requirements and file formats for datasets contributed to Vivli?

        Files contributed should be provided in a format that can be used by the standard statistical packages (SAS, STATA, Excel) used for analysis. Data sets are not required to be standardized; however, we highly recommend that data sets be made available in CDISC SDTM (Standard Data Tabulation Model) format to support the most efficient data aggregation, re-use, and sharing.

        What decisions over data governance should I make prior to making a data contribution in Vivli?

        See Share Data on our website.