Vivli Explained: Clinical Trial Data Sharing

Vivli is an independent, non-profit clinical trial data-sharing platform that acts as a neutral broker between organisations that hold participant-level trial data and researchers who want to reuse it. Rather than owning the data itself, Vivli operates the repository, search engine, and secure analysis environment, while two contractual instruments — the Data Use Agreement and the Data Contributor Agreement — govern who can access what, and under which conditions.

Vivli is a global, cloud-based data-sharing and analytics platform for individual participant-level clinical trial data, operated as an independent non-profit since 2016. This article explains how the platform actually functions in practice: what the two governing agreements require, how a data request moves through review, and what it costs to analyse data once access is granted.

• What is Vivli?
• How does the Vivli platform work?
• What is the Vivli Data Use Agreement?
• What is the Vivli Data Contributor Agreement?
• What does it cost to analyse data on Vivli?
• Common questions about Vivli
• Why this matters for research administrators

What is Vivli?

Vivli grew out of work at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. In 2013, the MRCT Center convened a diverse group of global stakeholders to define and design a shared solution to the fragmentation of clinical trial data sharing, and the resulting non-profit platform launched in 2016.

Vivli’s stated mission is to promote, coordinate, and facilitate the scientific reuse of clinical research data by building a sustainable global data-sharing enterprise, while explicitly positioning itself as a neutral broker rather than a data owner. That distinction matters: Vivli does not decide who gets access on commercial or institutional grounds — governance sits with the contributing organisation and independent review panels, not with Vivli’s own leadership.

How does the Vivli platform work?

The platform combines three technical components: an independent data repository, a search engine indexed to clinical trial metadata, and a secure cloud research environment. Researchers can run keyword or structured PICO (Population, Intervention, Comparator, Outcome) searches to identify relevant, listed studies before submitting a request.

• Data repository — holds anonymised, individual participant-level datasets contributed by academic institutions, pharmaceutical companies, and funders.
• Search engine — indexes study-level metadata so researchers can find eligible trials without needing prior access.
• Secure research environment — a cloud workspace where approved researchers analyse data without downloading it to a local machine.

The Vivli platform is built entirely within the Microsoft Azure cloud and has achieved SOC 2, Type 2 compliance following an independent audit, alongside a successful penetration test — infrastructure detail that matters to institutional data protection officers assessing whether to approve a data request through Vivli.

What is the Vivli Data Use Agreement?

The Data Use Agreement (DUA) is the contract every data requestor must execute before receiving access to a dataset on the Vivli platform. It is a mandatory, non-negotiable instrument: Vivli describes it as “the product of extensive negotiation” with the organisations that contribute data, meaning individual researchers cannot renegotiate its terms — they can only accept or decline.

In practice, the DUA process runs alongside a three-step data request review:

1. Administrative check — Vivli confirms the request form is complete and that a qualified statistician is named on the research team.
2. Data contributor feasibility review — the organisation that holds the trial data assesses whether the request is feasible to fulfil.
3. Independent Review Panel or Scientific Committee review — an external body assesses the scientific merit of the research proposal.

Once a request clears review, Vivli issues the appropriate DUA version to the requestor via DocuSign, appends the approved Final Research Plan as “Exhibit A” once negotiations conclude, and countersigns on behalf of the platform. Researchers from a different institution than the lead investigator must each execute their own DUA before touching the data — a detail that trips up multi-site teams who assume one signature covers the whole consortium.

What is the Vivli Data Contributor Agreement?

Where the DUA governs the researcher requesting data, the Data Contributor Agreement (DCA) governs the organisation supplying it. Institutions and companies that want to make trial data available through Vivli sign a master DCA that sets the standing terms under which their studies can be listed, requested, and reused — independent of any single research request.

This upstream/downstream split is easy to miss in generic clinical-research-governance writing, but it explains why the same university can appear on both sides of the platform: as an institution with a signed master DCA covering data it contributes, and separately as the employer of principal investigators who must still sign individual DUAs to request other organisations’ data. The University of California, San Francisco’s own library guidance to researchers illustrates this exact pattern — a signed institutional DCA does not substitute for a PI’s individual acknowledgement when requesting access.

What does it cost to analyse data on Vivli?

Requesting a dataset through Vivli carries no fee, but the secure research environment used to analyse it is metered by compute tier, with published 2025 pricing that scales from free introductory periods to specialist high-performance options.

All environments support two concurrent logins, and there is no cap on the total number of researchers who can access an environment across the life of a project. Standard statistical software — R, Python, STATA, and Jupyter Notebook — is available in every tier; SAS is reserved for Premium and above.

Common questions about Vivli

Is Vivli free to use?

Requesting and being granted access to a clinical trial dataset through Vivli carries no charge. The secure research environment used to analyse that data is free for an introductory period — 365 days on the Standard tier, 90 days on Premium — after which daily compute charges apply based on the tier selected.

Who owns Vivli?

No single company, government, or funder owns Vivli. It operates as an independent, non-profit organisation governed as a neutral broker between data contributors and data requestors, a structure that grew out of Harvard’s Multi-Regional Clinical Trials Center and was designed deliberately to avoid commercial or institutional gatekeeping.

How do I request data on Vivli?

Researchers search listed studies on the Vivli platform, submit a data request naming a qualified statistician, and pass a three-step review — administrative check, data contributor feasibility review, and independent scientific review — before executing a Data Use Agreement to receive the dataset.

What is Vivli AMR?

Vivli AMR is a dedicated instance of the platform, hosted at amr.vivli.org, built specifically for antimicrobial resistance surveillance data. It applies the same contributor/requestor agreement model as the main Vivli platform but to AMR-specific studies, reflecting demand for a distinct governance track for that data domain.

Why this matters for research administrators

For institutional research offices, the DUA/DCA split is the practical detail that most generic “data sharing” explainers skip. Signing a master Data Contributor Agreement is an institutional act, typically negotiated once by a research office or general counsel. Executing a Data Use Agreement is a per-request act tied to a named principal investigator and research plan, and it does not transfer automatically to co-investigators at other institutions.

Research administrators supporting multi-site clinical research should treat these as two separate compliance tracks: one covering what the institution has agreed to contribute, and one covering what each individual investigator has been approved to receive. Budgeting for a data request should also account for research-environment compute charges beyond any free introductory period, particularly for large-scale reanalyses that outgrow the Standard or Premium tiers.

As data-sharing mandates from funders and journals continue to tighten, platforms structured around explicit, separable contributor and user agreements — rather than a single blanket licence — are likely to remain the reference model for how third-party clinical trial data sharing is operationalised at scale.