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 email@example.com.
Getting started with the Vivli platform
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.
- 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 goes into effect 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.
Logging into the Vivli platform is easy! Check out our quick start guide to help you through the process.
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.
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.
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 firstname.lastname@example.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.
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.
Requesting access to 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.
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.
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.
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.
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.
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.
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.
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 email@example.com for any questions related to the uploading of additional tools, data and scripts.
Sharing data on the Vivli platform
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.
Learn about the the fee breakdown for sharing your data here: How to Share Data
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 How to Share Data.
Vivli currently does not offer comprehensive curation services, though we do offer anonymization through anonymization partners. If you need help with anonymization, contact our support team at firstname.lastname@example.org to discuss your options.
All data sets are assigned a unique Digital Object Identifier (DOI), which helps make data sets easily discoverable and easy to trace when cited.
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.
See How to Share Data on our website.
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.
Yes, Vivli will only host anonymized data in its system. To assist in this process, Vivli collaborates with Privacy Analytics, an industry leader in health data-sharing methods and technologies, data security and de-identification. This partnership offers anonymization services to individuals and organizations who wish to share clinical data on the Vivli platform. For more information, contact email@example.com.
Vivli users can contribute files up to 10 GB. If your file is larger than this, please contact Vivli Support at firstname.lastname@example.org.
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.
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 email@example.com
You may update your data or request that your data is deleted by contacting the Vivli team at firstname.lastname@example.org.
Data sets can be embargoed. This may be useful if a grant is ending but you are still working on a manuscript. In that case, you may make the study available on the platform and let the Vivli team know when it will be ready for sharing.