Investigator-Initiated Clinical Research Agreements take on many forms, but always involve research using human subjects. The protocol of an investigator-initiated clinical study is almost always produced by the Principal Investigator, and is conducted by University researchers at one of the University's Affiliated Hospitals.

Characteristics:

• Principal Investigator (PI), either at UBC or at another academic institution/hospital writes the Protocol
• Sponsor/Granting Agency may provide funding with or without a study drug or device
• Granting Agency or Sponsor may provide funding
• If this is a new use or new application of an existing drug, or a new investigational drug or medical device, the PI must apply and obtain Health Protection Branch - Canada approval and thus becomes the "REGULATORY SPONSOR"
• UBC owns inventions, software, biological materials, know-how, or other intellectual property ("UBC IP")
• UBC may grant the Sponsor an option for a royalty-bearing license to use UBC IP
• 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 will protect confidential information clearly defined and provided by the Sponsor

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

Required documents before agreement can be drafted:

• Proposal and budget (which we will attach as a Schedule to the Clinical Research Agreement)
• Sponsored Research Information Form (Questionnaire)(This form can be saved, complete with data, with the latest versions of Acrobat Reader)

Sample template agreements:

• Subsite Agreement (only for use with other academic institutions)

Contact: Yasmin Diaz 604-827-5025