Clinical Research Agreements are a special form of Fee-for-Service Arrangement that involve a trial using human subjects. Sponsor-initiated clinical trials are normally conducted by University researchers at one of the University's affiliated hospitals.

Characteristics:

• Sponsor Initiated - Phase I, II, III, IV
• Sponsor owns the Protocol and Drug or Device
• Patient-based clinical research
• Publication may be temporarily delayed (within clearly defined limits) to protect commercial interests. In the case of a multi-centre study, publication may be delayed until the study has been reported in full by all participating centres.
• UBC/Affiliated Hospital will protect confidential information clearly defined and provided by the Sponsor
• Particular care must be taken to include indemnification and insurance provision in these agreements

Parties to the Agreement: UBC Affiliated Hospital, Principal Investigator and Sponsor.

University Restrictions:

• University and Affiliated Hospitals may disclose the following without the Sponsor's consent:
  The Project Title; UBC/ Hospital, Sponsor and Investigator names; total Amount; and Contract Period; and
• Sponsor must indemnify University, Hospital and Investigator for all claims resulting from the trial.

Contact: J.P. Heale 604-875-5491