Sponsor-Initiated Clinical Research Agreements

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


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