Contracting Process - General

The Office of Clinical Trials (OCT) is responsible for the review, negotiation, and execution of all clinical trial agreements (CTAs) on behalf of New York University School of Medicine (the School of Medicine).

For all clinical trials at the School of Medicine in which a private industry sponsor (the Sponsor) is providing monetary or material support, the parties must enter into a written CTA. A completed CTA is required before the commencement of any clinical trial supported by a Sponsor. Accordingly, 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.

The CTA is a contract between the School of Medicine and the Sponsor. 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. 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 in the space provided.

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

The OCT attempts to review initial drafts of CTAs within two (2) weeks of receipt of the CTA, the protocol and other necessary trial documentation from the sponsor and the Principal Investigator. The overall process for review, negotiation and execution of a CTA takes, on average, from two (2) to four (4) months.

The OCT will periodically update the Principal Investigator as to the status of negotiations. After the CTA has been successfully negotiated, the OCT will send a copy to the Principal Investigator for final review. Following approval of the negotiated CTA by the Principal Investigator, 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.

Contracting Issues

 

CTAs often contain many terms that School of Medicine policy requires the OCT to negotiate. Some CTA terms commonly negotiated by the OCT include:

• 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 such terms are not consistent with reasonable business terms for the conduct of a particular clinical trial at the School of Medicine

OCT Institutional Information

 

Party	New York University School of Medicine
Type of Organization	an administrative unit of New York University, a non-profit educational institution of the State of New York
Authorized organization representative and official signing for applicant organization	Jean M. Gatewood Director Phone: (212) 263-4211 Fax: (212) 263-4111 E-mail: clinicaltrials@nyumc.org New York University School of Medicine Office of Clinical Trials 550 First Avenue Bldg. VET 10W New York, NY 10016
Principal Investigator	Faculty Name (or investigator to serve as project correspondent if there are co-investigators)
Contract Contacts	Floyd Berry Phone: (212) 263-4209 Fax: (212) 263-4111 E-mail: Floyd.Berry@nyumc.org AND Mihail Gilevich Phone: (212) 263-4202 Fax: (212) 263-41111 E-mail: Mihail.Gilevich@nyumc.org New York University School of Medicine Office of Clinical Trials 550 First Avenue Bldg. VET 10W Room 10035W New York, NY 10016
Checks should be made payable to	New York University School of Medicine
Send checks to the attention of	NYU School of Medicine-Office of Clinical Trials PO Box 33450 Hartford, CT 06150-3450
Tax ID No. (TIN)	13-5562308