What does the Clinical and Corporate Contract area need from me and when?

Involve us as early as possible. Communications are key. Try to provide University of Pittsburgh forms of agreement to your PIs and sponsors as starting points for discussions. If using the sponsor's form, give us electronic drafts of agreements to review/negotiate from. Make sure all compliance approvals are in order and sent to us. Make sure that all compliance trainings have been completed. Above all, be patient! This takes time.

Who can sign a research contract?

The University of Pittsburgh's Office of Research is designated as the office to enter into research contracts on behalf of the University. This includes MTAs and other non financial agreements which relate to research. When a researcher attempts to sign such an agreement on behalf of the University of Pittsburgh, the researcher could be subjected to personal legal and financial risks. Even MTAs, while usually not conveying funding, are still binding documents with possible legal penalties for violations of the terms.

Should a PI or department staff member negotiate their own contract?

Never. The Office of Research is the only official office authorized to accept binding terms in research contracts on behalf of the University. The PI and department are certainly permitted (and are encouraged) to discuss the scope of work and the budget with a sponsor, but the rest of the contract terms are the purview of the Office of Research. Only those terms reflected in the final, executed contract are binding on the parties. Communications between the PI or department in the sponsor may lead to confusion over the contract terms.

It is important for the researcher to read the terms of all research agreements before transmitting it for University signature. The Office of Research assumes that a researcher who transmits a contract has read and agrees to conform to those terms (http://www.pitt.edu/HOME/PP/policies/11/11-01-02.html).

Note: The Office of Research will confer with General Counsel and the Office of Technology Management, or any necessary compliance office as required in the review and negotiation of any research contracts.

What is the role of the UPMC Clinical Trials Office (CTO) and how do we work together?

The UPMC Clinical Trials Office (http://www.irb.pitt.edu/CTO/cto.htm) was established under a formal agreement between the University of Pittsburgh and the UPMC for the purpose of facilitating the implementation of industry-initiated and sponsored clinical trials being conducted by Physician Services Division (PSD) or UPMC investigators within the UPMC environment. Our offices talk almost daily on issues regarding consistency in agreement requirements and to discuss appropriate routing of agreements.

The purview of the UPMC Clinical Trials Office is limited to industry-initiated and sponsored clinical trial of drugs and devices conducted within a UPMC or University of Pittsburgh Physicians (UPP) facility or conducted under the direction of a UPMC or UPP staff member in connection with his/her UPMC and/or UPP responsibilities, appointments and clinical privileges, as appropriate.

Checklist of Applicability for Submission to UPMC CTO