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.
- 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