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The Office of Sponsored Projects’ Clinical Agreements Team is authorized to negotiate and execute non-federal clinical trial agreements on behalf of Yale University, in accordance with University Policy 1104, and also provides a comprehensive and transparent approach to activities related to industry-supported clinical trial agreements. Specifically, the team’s responsibilities to assist in ensuring a timely initiation of industry-supported clinical trial at Yale, and include but are not limited to the following:
- Developing, reviewing, negotiating, and executing clinical trial agreements, 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
- Collaborating and consulting with other University offices including the Human Research Protection Program (HRPP), the Office of Research Administration (ORA), the Yale Center for Clinical Investigation (YCCI), and the Office of General Counsel (OGC) regarding clinical trial activities and issues
Affiliation between Yale University and Yale-New Haven Hospital
Yale University serves as the contracting entity for all clinical trial agreements. Yale University and the Yale-New Haven Health System are affiliated entities with a long-standing relationship. 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 Trial 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 the University. The Principal Investigator and other clinical trial investigators may be asked to read and acknowledge such documents only.
- IND/IDE Support
- Data and Safety Monitoring Committee and Plan
- Research Guidance, Study Tools and Templates
- Clinical Trial FAQs
- Registering a Study on ClinicalTrials.gov
- Sponsored Projects Policies, Procedures, and Forms
- Human Research Policies, Procedures, Guidance, and Checklists