Category: About
Why we support Vivli
Independent Review Panel
An experienced independent consultant acts as the secretariat for the Independent Review Panel (IRP). Data contributors can choose to have an independent, neutral party oversee the review of requests by accessing the esteemed Independent Review Panel who will review research proposals based on their merit.
For more information, please review the Independent Review Panel Charter. Read more about the IRP members.
How to Guides
Vivli provides the following resources to assist users of the Vivli Platform:
Data Request Guidance and Support
| Resource | Description | |
|---|---|---|
| Vivli User Account Quick Start guide | How 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 Account | Video detailing how to sign up for a Vivli platform account | Watch Video |
| Vivli How To – Requesting Studies | How 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 Vivli | A short video showing how to request data on Vivli | Watch video |
| Vivli Lay Summary Training Video | Hints and tips for completing your Vivli Lay Summary as part of your data request. | Watch video Download PDF |
| Vivli Data Request Form Worksheet | Worksheet of information needed to complete a Vivli data request | Download |
| Vivli Data Request Form Tips and Tricks | Hints and tips for completing your Vivli Data Request Form. | Download PDF |
| Data Request Form Sample | Example of fully completed Data Request Form | Download PDF |
| Vivli Policies in Brief | Synopsis 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 Environment | Analytical and other software available in the research environment | Download PDF |
Study Submission Guidance and Support
| Resource | Description | |
|---|---|---|
| Vivli User Account Quick Start guide | How 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 Account | Video detailing how to sign up for a Vivli platform account | Watch Video |
| Vivli Study Submission Guide | How to submit studies for sharing via the Vivli platform | Download PDF |
| Vivli How To – Study submission | Data sharing instructional video | Watch Video |
| Study Submission Checklist | A checklist of all information needed for the submission of a study | Download |
| ICMJE Data Sharing Requirements | How to use Vivli to meet ICMJE data sharing requirements | Download PDF |
NIH DMSP Guidance
Fill out the form below to access all the DMSP Guidance provided by Vivli.
Vivli Metrics
Vivli 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 28 February 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:
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 Summaries | Julie Wood Rebecca Li, PhD |
| May 5, 2021 | "Data Sharing in a Time of Pandemic", a webinar with Front Line Genomics | Rebecca 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 Network | Rebecca Li, PhD |
| March 26, 2021 | "Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit Series | Ida Sim, MD, PhD |
| January 19, 2021 | "Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter Meeting | Rebecca Li, PhD |
| December 11, 2020 | "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinar | Ida 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 Conference | Rebecca Li, PhD |
| August 18, 2020 | "Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health Policy | Rebecca 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 Workshop | Rebecca Li, PhD |
| October 10, 2019 | "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium Webinar | Ida 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 Rounds | Rebecca 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 World | Rebecca 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 Kong | Rebecca Li, PhD |
| March 27, 2019 | “Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CA | Ida Sim, MD, PhD |
| January 30, 2019 | “The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PA | Julie Wood Thomas Wicks (TrialScope) |
| October 25, 2018 | "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, London | Rebecca 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 CA | Ida Sim, MD, PhD |
| November 17, 2017 | “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TX | Ida Sim, MD, PhD |
Enquiries about Vivli Member Studies
To enquire about a study not listed on Vivli or for additional study information not included in a study listing, please complete the below fields. To request multiple studies from the same Member, please list the all study IDs in the “Study ID” field. Please note you must enter at least one study in the Study ID field to submit your enquiry. If you have enquiries for multiple Members, please submit a new form for each Member.
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.
If a Member responds that a study is available, a data request will need to be submitted via the Vivli platform. In order to request access to study data, you must become a Vivli user. Additional information on how to get started is available in our resources section.
Have a question and need to get in touch with the Vivli team? Contact us.
Vivli Committees
The Vivli Steering Committee comprises representatives from Vivli members. This group includes institutional data contributors from academia, governmental, industry, and non-profit organizations and meets regularly to discuss operational, governance, and policy issues.
The Vivli External Advisory Committee brings together a diverse group of influential leaders with a commitment to data transparency. These leaders provide knowledge and insights based on their experience and expertise in their respective fields on a broad range of issues related to governance, implementation, and strategic planning. This external perspective supports Vivli’s growth as an institution.
- Sergio Bonini, Italian National Research Council (CNR), Institute of Translational Pharmacology
- Jeffrey Drazen, New England Journal of Medicine
- Dave Evans, CDISC
- Nina Hill, Hill Scientific and Public Affairs
- Karmela Krleza-Jeric, Impact Observatory, MedILS
- Young-Joo Lee, Johns Hopkins University
- Bernard Lo, UCSF
- Joshua Mann, VHL Alliance
- Jan McGonagle, Amoskeag Health
- Vasee Moorthy, World Health Organization
- Brian Nosek, Center for Open Science
- Amy Nurnberger, MIT
- Jane Perlmutter, Gemini Group
- Larysa Rydzewska, MRC Clinical Trials Unit at UCL
- Lon Schneider, University of Southern California
- Carolyn Shore, National Academies of Sciences (NAS) Observer
- Karla Soares-Weiser, Cochrane
- Catrin Tudur Smith, Liverpool University
- Megan von Isenburg, Duke Medical Center Library and Archives
- David Vulcano, HCA Healthcare
- Daoxin Yin, Peking University, Health Science Center
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?
You can use our enquiry form to ask about a study from one of our Members that is not listed on Vivli, or for any additional study information not included in the study listing. It’s important to note that users can only request studies from Vivli Members.
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.