YODA Project — Yale Open Data Access

Overview

The Yale University Open Data Access (YODA) Project is an independent, academic initiative housed at Yale University that facilitates responsible sharing of individual participant-level clinical trial data. Founded in 2013 by Joseph Ross and Harlan Krumholz at Yale School of Medicine, YODA operates as a trusted third-party intermediary between industry data holders and external researchers, taking full jurisdiction over data access decisions and removing conflicts of interest from the data sharing process. Its mission is to promote open science and research transparency by making clinical trial data available for secondary analysis while protecting participant confidentiality.

Model and Scope

YODA’s data-sharing model gives YODA independent jurisdiction: data partners contractually transfer full decision-making authority to YODA, so the Project rather than the data owner grants or denies access. As of 2024, 499 trials are available, predominantly pharmaceutical and medical device trials from partners including Johnson & Johnson and SI-BONE, with approximately 385 requests processed at a roughly 95% approval rate. All requests and decisions are publicly posted for transparency. Approved researchers access data alongside protocols, analysis plans, and clinical study reports in a secure enclave.

Data Access Process

• Researcher submits a proposal with an analysis plan via the YODA website.
• YODA Steering Committee reviews the proposal alongside a blinded review by the data partner.
• Conflict of interest disclosure is required.
• A Data Use Agreement (DUA) is signed prior to access.
• All requests, decisions, and outcomes are publicly posted for transparency.

Policy Influence

YODA has had direct influence on US and international data sharing policy. It informed the NIH Data Sharing Policy strengthening (enacted 2023), which now requires all NIH-funded investigators to share data. It provided proof-of-concept that large-scale clinical trial data sharing is feasible without disrupting pharmaceutical operations, changing industry attitudes toward data sharing. Co-founders Ross and Krumholz subsequently co-founded medRxiv (see Preprint Servers), extending their open science mission to preprints.

Connections

• Coordination with: VIVLI (complementary clinical trial data sharing platform)
• Partner: TransCelerate

Resources

• https://yoda.yale.edu
• https://yoda.yale.edu/about/policies-procedures/ (governance policy)
• https://doi.org/10.1038/sdata2018268 (5-year overview paper, Scientific Data)