Vivli is an independent, non-profit clinical trial data-sharing platform: a searchable repository of individual participant-level data (IPD) from completed clinical trials, paired with a controlled request-and-review process and a browser-based secure research environment where approved researchers analyze data without downloading it. It grew out of a project at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard, and the platform itself launched publicly in July 2018 with data from more than 4,000 clinical studies contributed by eight founding companies and non-profits.
For research administrators and investigators, Vivli matters less as a place to browse than as a process to navigate: getting access to a dataset means passing through several sequential checks, executing a data use agreement, and then working inside Vivli’s own analysis environment rather than on a downloaded file. This guide walks through that process end to end — what Vivli hosts, who can request it, each review stage, typical timelines, and what the secure research environment costs.
What Vivli hosts, and who contributes data
Vivli’s catalogue is built from individual participant-level data voluntarily deposited by pharmaceutical and biotech companies, academic medical centers, funders, and other trial sponsors. A contributor decides, study by study, whether and under what conditions its data becomes searchable and requestable through the platform; Vivli itself does not compel sponsors to share, it provides the shared infrastructure — catalogue, request workflow, review coordination, and analysis environment — that makes voluntary sharing practical at scale. Vivli is also one of the repositories participating in the NIH’s Generalist Repository Ecosystem Initiative (GREI), which is relevant for investigators whose NIH Data Management and Sharing Plan needs to name a repository capable of handling clinical trial IPD specifically, rather than a general-purpose generalist repository.
This distinguishes Vivli from a conventional open-access repository in a specific way: nothing in the catalogue is available for anonymous download. Every dataset sits behind the request-and-review process described below, and access is granted to a named research team for a defined, agreed use — not published to the public web.
Who can request data, and what a request needs to contain
Vivli’s data request form is intended for a qualified research team, not an individual browsing out of curiosity. Vivli’s own guidance for requesters specifies that a qualified statistician be part of the requesting team, since the administrative check (the first review stage, below) confirms this before the request moves forward. A request identifies the specific study or studies wanted, states a research question and analysis plan, and names the individuals who will have access — each of whom is bound, individually, by the data use agreement once one is executed.
The data request and access-review process, step by step
1. Search the catalogue and identify studies
Researchers create an account and use Vivli’s search interface (at search.vivli.org) to find studies by condition, intervention, sponsor, or other study-level metadata before submitting a request. Because contributors can attach different sharing conditions to different studies, what a given study’s owner will actually make available — individual patient data, protocols, or associated documents — can vary from study to study within the same catalogue.
2. Submit a data request
The researcher completes Vivli’s data request form, specifying the study or studies, the research team, and a written research proposal describing the question, hypothesis, and analysis approach. This is the point at which the request enters formal review.
3. Administrative check
Vivli staff first verify the request is complete — required fields filled in, a qualified statistician named on the team, and the proposal legible as a research plan — before it is passed along. This stage screens for completeness, not scientific merit.
4. Data contributor feasibility review
The organization that deposited the requested study or studies then assesses whether the request is feasible to fulfill: whether the data as deposited can actually answer the proposed question, whether there are conflicting commitments (e.g., an ongoing analysis by the original trial team), and whether the contributor is willing to proceed. Not every study requires every downstream review step; a contributor can route its own studies through a lighter review path if it chooses.
5. Independent Review Panel or scientific review
Requests that clear the feasibility check go to a merit-based scientific review — for many contributors this is Vivli’s Independent Review Panel (IRP), a body of external reviewers who evaluate the scientific and ethical merit of the proposed research independently of the data contributor. Some contributors instead route requests through their own scientific review committee rather than the shared IRP. Either way, the reviewing body can approve, reject, or request revisions to the proposal before deciding.
6. Data use agreement (DUA)
Once a request is approved, Vivli requires a data use agreement before any data becomes accessible. Vivli describes its DUA terms as non-negotiable: the researcher acknowledges the agreement (via DocuSign), Vivli reviews it, an institutional signing authority at the researcher’s organization executes it, and the final, signed agreement has the approved research plan attached as an exhibit. Because the DUA is executed per person, each member of a multi-institution research team needs their own signed agreement before they can access the data, not just one agreement covering the whole team.
7. Access through the secure research environment
Approved data is not sent to the researcher as a downloadable file. Instead, Vivli anonymizes and loads the dataset into a cloud-based secure research environment that the research team logs into to run their analysis; the data itself never leaves Vivli’s infrastructure. This is the same basic access model used by comparable controlled-access biomedical data platforms (for example, dbGaP’s cloud-based workspaces for genotype-phenotype data), and it is what lets contributors share individual participant data while keeping re-identification risk and downstream redistribution under much tighter control than a file download would allow.
How long the process takes
Vivli describes the typical time from request submission to data access as a few months, but this varies considerably by request: it depends on how many separate data contributors and studies are involved (each contributor runs its own feasibility review), how much back-and-forth the scientific review generates, and how quickly the requesting team responds to reviewer comments or revision requests. A single-study, single-contributor request with a well-specified proposal moves faster than a multi-study request spanning several contributors, each with its own review timeline running in parallel or in sequence.
What it costs
Requesting and reviewing data through Vivli does not carry a listed request fee, but the secure research environment itself has tiered costs once access is granted. Vivli’s Standard analysis environment is free to use for 365 days from the point data is made available. Higher-capacity environments are billed by the day — for example, a Memory Optimized environment for computationally heavier analyses is priced at $275/day. Teams that need to bring their own analysis tools into the environment may also face a setup cost. Because these charges accrue after approval, they are worth budgeting for at the proposal stage rather than discovering once the data use agreement is already signed.
Where Vivli fits among clinical trial data-sharing platforms
Vivli is one of several platforms that implement the sponsor commitments described under the umbrella of clinical trial transparency — alongside other individual participant data request portals such as the Yale Open Data Access (YODA) Project and the Clinical Study Data Request (CSDR) platform used by a number of pharmaceutical sponsors. All of these platforms share the same basic shape — a public catalogue, a merit-based review gate, a data use agreement, and a controlled analysis environment — because they are responding to the same underlying problem: sponsors are willing to share individual-level trial data but only under terms that protect participant privacy and prevent uncontrolled redistribution. Where they differ is mainly in which sponsors and studies each one hosts, and in the specific review body each uses; a request for a particular trial’s data generally has to go through whichever platform that trial’s sponsor actually deposited it with, so identifying the right platform for a specific study is itself the first step, before any request process begins.
Vivli’s model is a request for a defined dataset to answer a specific, reviewed research question, which is a narrower and slower path than downloading an openly licensed dataset. It sits downstream of, and is complementary to, other clinical trial transparency mechanisms: prospective registration and summary clinical study reports establish that a trial exists and what it found, while platforms like Vivli govern secondary access to the underlying participant-level data behind those results. A data availability statement in a resulting publication is the typical place a researcher discloses that data came from a Vivli-mediated request, including any access restrictions that still apply.
Frequently asked questions
Does Vivli let me download individual participant data directly?
No. Approved researchers work with the data inside Vivli’s cloud-based secure research environment; the underlying data does not leave Vivli’s infrastructure as a downloadable file. This is a deliberate control, not a technical limitation.
Do I need a statistician on my team to request data from Vivli?
Vivli’s guidance for requesters specifies that a qualified statistician be part of the requesting team, and the administrative check confirms this before a request proceeds to feasibility and scientific review.
Is the Vivli data use agreement negotiable?
Vivli describes its DUA as non-negotiable. Researchers acknowledge it via DocuSign, Vivli reviews the acknowledgment, and an institutional signing authority at the researcher’s own organization must execute it before access is granted; each team member needs their own signed agreement.
How much does it cost to use Vivli’s secure research environment?
The Standard analysis environment is free for 365 days once access is granted. Higher-capacity environments are billed by the day, with a Memory Optimized option listed at $275/day for more computationally demanding analyses; researcher-supplied tools may add setup costs.
How is Vivli different from YODA or CSDR?
All three are controlled-access request-and-review platforms for individual participant clinical trial data with broadly similar review-then-DUA-then-analysis-environment structures. They differ mainly in which sponsors and studies they host and which body conducts scientific review, so which platform applies to a given trial depends on where that trial’s sponsor chose to deposit its data.
This guide describes Vivli’s publicly documented process as of 2026 and is for general planning purposes; always confirm current requirements, forms, and fees directly with Vivli (vivli.org) before submitting a request, since review criteria and environment pricing can change.
