Vivli (concept)

Vivli is a non-profit, independent 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 ever 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 launched publicly in July 2018 with data from more than 4,000 clinical studies contributed by eight founding companies and non-profits.

What makes Vivli different from a generalist repository

Sites like generalist repositories (Zenodo, Figshare, Dryad) accept a deposit and make it immediately downloadable to anyone. Vivli inverts that model on purpose, because the underlying data is patient-level clinical information rather than a dataset a depositor already intends to be fully open: a data contributor decides, study by study, whether and under what conditions its data becomes searchable, and a requester must pass through Vivli’s own review stages before any access is granted at all.

How the request-and-review process works

Getting access to a study on Vivli means clearing three sequential checks, not one: (1) a Vivli administrative completeness check, which requires the requesting team to include a qualified statistician; (2) the data contributor’s own feasibility review of the proposed research question against the study; and (3) a merit-based scientific review, carried out either by Vivli’s Independent Review Panel (IRP) or, for some contributors, the contributor’s own scientific review committee. Only after all three stages clear does a requester execute a data use agreement — a separate, non-negotiable agreement per team member, not one per team — and gain access. Vivli itself describes typical time from submission to data access as “a few months,” varying with how many studies and data contributors are involved. Once access is granted, analysis happens entirely inside Vivli’s cloud-based secure research environment; the standard environment tier is free for 365 days, with a higher-memory tier priced separately. See the companion guide, Vivli: How the Data Request and Access-Review Process Works, for a full stage-by-stage walkthrough.

Where Vivli fits among clinical-trial data infrastructure

Vivli is one of several platforms research administrators may encounter when a funder or journal’s data-sharing policy applies to clinical trial data specifically, rather than research data generally. It sits alongside dataset-level infrastructure like dbGaP (NIH’s controlled-access repository for genotype/phenotype data) and the All of Us Researcher Workbench (tiered-access analysis environment for a specific NIH cohort), and complements rather than replaces prospective clinical trial registration on registries such as ClinicalTrials.gov — registration records that a trial exists and what it measured; Vivli is where the underlying individual participant data can actually be requested once the trial has completed. A data use agreement governs the terms of access in both cases, but Vivli’s DUA process is Vivli-specific and executed after its own independent review, not a generic template.

Who uses Vivli

Two distinct groups interact with Vivli: data contributors (pharmaceutical and biotech companies, academic medical centers, funders, and other trial sponsors) who deposit study metadata and decide access conditions study by study, and researchers (academic investigators, meta-analysts, and secondary-data researchers) who search the catalogue and submit data requests. A research administrator’s most common point of contact with Vivli is helping an investigator scope and submit a data request — including budgeting for the statistician the administrative check requires and for the secure research environment’s compute costs once access is granted.