Clinical Trials

    Clinical Trial Agreements

    The Office of Sponsored Projects’ Clinical Agreements Team is authorized to negotiate and execute non-federal clinical trial agreements (CTAs) on behalf of Yale University, in accordance with University Policy 1104. The team provides a comprehensive and transparent approach to all activities related to industry-supported clinical trial agreements (CTAs). Specifically, the team’s responsibilities to assist in ensuring a timely initiation of industry-supported clinical trials at Yale, include, but are not limited to, the following:

    • Developing, reviewing, negotiating, and executing clinical trial agreements (CTAs), confidential disclosure agreements (CDAs) and other related sponsor documents
    • Assisting in the negotiation of clinical trial budget and informed consent documents to ensure consistency across all clinical trial documents
    • Providing guidance to faculty and staff regarding the interpretation of contract provisions, federal regulations, University policies, and sponsor requirements, and
    • Collaborating and consulting with other University offices including the Human Research Protection Program (HRPP), the Yale Center for Clinical Investigation (YCCI), and the Office of General Counsel (OGC) regarding clinical trial activities and issues.

    The OSP process for setting up an industry-sponsored clinical trial should occur in parallel with the budget negotiations and the IRB approval process. View the details of this process on the clinical trial process flowchart.

    Relationship between Yale University and Yale New Haven Health System

    Yale University and the Yale-New Haven Health System are affiliated entities with a long-standing relationship, and Yale University serves as the contracting entity for all clinical trial agreements. Together, they share the following common objectives regarding the conduct of clinical trials at Yale:

    • One point of contact for the sponsors of clinical trials
    • Coordination of data collection and analysis
    • Access to an expanding faculty base and a large and diverse patient population
    • Contribute to the clinical distinctiveness of Yale University and Yale-New Haven Health System by offering new therapies and technologies through participation in innovative clinical trials.

    Please note: the Clinical Agreements team has the authority to execute (i.e., sign) clinical trial documentation (e.g., clinical trial agreements and confidential disclosure agreements (CDAs)) that legally binds Yale University. The Principal Investigator and other clinical trial investigators are not authorized to sign such documents on behalf of the University and may be asked only to read and acknowledge such documents.