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Roles & Responsibilities

What the YODA Project Does
The YODA Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports [CSRs], with the aim of promoting scientific research that may advance science or lead to improvements in individual and public health and healthcare delivery. The YODA Project has served as a trusted third party in a variety of collaborative efforts to make scientific data more broadly available to researchers for the betterment of patients, scientific research, and society. Ongoing projects include conducting independent reviews of requests for access to pharmaceutical and medical device company data that could enable new scientific discoveries. As the expectation for open science and research transparency expands, the YODA Project continues to evolve as a leader in responsible data access while maintaining the touchstone of its core values.

What the YODA Project Does Not Do
The YODA Project has not generated nor owns the data being made available through these open science projects. This impartial perspective enables the YODA Project to promote its principles in a manner uninfluenced by individual stakeholder biases and to work as a mediator, facilitator, and activist for responsible data sharing.

Clear roles and responsibilities have been delineated for both the YODA Project and for all partnered Data Holders.

The YODA Project is committed to:
• Facilitating requests for access to clinical trial data
• Conducting independent, third-party reviews of these requests
• Providing access to data following approval of data requests
• Ensuring that data shared through the YODA Project are used to generate knowledge and inform science and public health

Data Holders are committed to:
• Making all possible clinical trial data available to external investigators
• Handling any operational/technical aspects of data access
• Posting all completed trial results on ClinicalTrials.gov as soon as available

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