Clinical Trial Agreement

Sponsor: [Company Name] · Institution/Investigator: [Name] · Protocol: [Protocol Title/Number] · Date: [Date]

1. Study Conduct

Institution will conduct the clinical trial described in the protocol referenced above, in accordance with the protocol, applicable law (e.g. Good Clinical Practice/FDA regulations), and IRB/ethics committee approval.

2. Enrollment

Institution will enroll approximately [Number] subjects, per the inclusion/exclusion criteria in the protocol.

3. Compensation

Sponsor will pay Institution [Amount] per enrolled/completed subject, plus [Amount] for [specific milestones/procedures], per the budget in Exhibit A.

4. Injury/Indemnification

Sponsor will [cover the cost of treating study-related injuries to subjects / indemnify Institution for claims arising from the study], except where caused by Institution's negligence or protocol deviation.

5. Data and Publication

Sponsor owns the study data. Institution may publish results after [Sponsor review period, e.g. 60-90 days] for confidentiality/patent review, subject to a right to remove Sponsor's confidential information (not data).

6. Confidentiality

Institution will keep Sponsor's proprietary information confidential, except study data required to be reported per regulatory or ethical obligations.

7. Term and Termination

This Agreement continues until study completion or is terminated by either party with [Notice Period] notice, subject to Institution completing necessary subject safety follow-up.

Sponsor: ______________________ Date: ____________ Institution/Investigator: ______________________ Date: ____________

*This document is provided for informational and educational purposes only and does not constitute legal advice. Publication rights (Section 5) are one of the most negotiated terms in clinical trial agreements — an institution should push back hard on any clause letting a sponsor suppress unfavorable results indefinitely, not just delay them for a defined review period.*