Clinical Trial Agreements

The Office of Clinical Trials is responsible for the review, negotiation, and execution of all Clinical Trial Agreements (CTAs) on behalf of the NYU School of Medicine.

NEW: Video - OCT Director Jean Gatewood discusses changes related to CTAs and other information.

What is a CTA:

A CTA is a contract between the School of Medicine and the Sponsor of a clinical trial. A CTA defines the scope of work and formalizes the understandings between the parties and contains legal and financial terms related to the conduct of a clinical trial.

When is a CTA required:

A written CTA is required for all clinical trials at the NYU School of Medicine in which a private industry sponsor is providing monetary or material support. A completed CTA is required before any clinical trial supported by a Sponsor can begin. Neither sponsor-initiated clinical trials developed and sponsored by the sponsor nor investigator-initiated clinical trials developed by a Principal Investigator (PI) at the School of Medicine and merely supported by a sponsor may commence until the School of Medicine, acting through the OCT, and sponsor have agreed to a CTA.

Role of the PI:

Individual faculty members, such as the Principal Investigator, may not contractually bind the School of Medicine to a CTA. For all CTAs, however, the Principal Investigator is asked to read the CTA, acknowledge that they have reviewed the CTA, and agree to be bound by its terms and conditions. The OCT will not sign a CTA until the Principal Investigator has acknowledged his or her review and agreement to the CTA’s terms by signing it.

Terms of the CTA:

The terms and conditions of a CTA are negotiated in accordance with School of Medicine policy. OCT staff will work with the Sponsor to revise the original draft of the agreement until it is acceptable to both parties. The OCT may use the applicable School of Medicine standard clinical trial agreement. However, most sponsors have their own standard agreements, which they prefer to use.

Negotiated issues:

Among the many issues commonly negotiated by the OCT are:

        * Publication rights

        * Indemnification

        * Subject Injury

        * Insurance

        * Intellectual property and invention rights

        * Publicity and use of name

        * Study Conduct

        * Termination and Survival

        * Governing law, Jurisdiction and Arbitration

        * Foreign Laws

This list is not intended to be exhaustive or limiting. The OCT may negotiate many other terms in a CTA if necessary for the conduct of a particular clinical trial.

Review timeframe:

The OCT attempts to review initial drafts of CTAs within two weeks after receiving the CTA, the protocol and other necessary trial documentation from the sponsor and the principal investigator. On average, the process of review, negotiation and execution of a CTA takes between 2-4 months.

The OCT will periodically update the Principal Investigator on the status of negotiations. After the CTA has been successfully negotiated, the OCT will send a copy to the Principal Investigator for final review. After the Principal Investigator approves the negotiated CTA, the OCT will sign the CTA and return it to the Sponsor for signature (if the Sponsor has not signed already).

A CTA is fully executed only after both the Sponsor and the OCT, on behalf of the School of Medicine, have signed.