CTA Review Process

Clinical trial research funded by a sponsor that may be a drug or a device company or an academic institution requires a contract between the sponsor, the Fraser Health principal investigator and Fraser Health. In order to provide contract expertise and timely service, a service agreement with the University of British Columbia's Industry Liaison Office (UILO) provides high priority service for the negotiation of clinical trial agreements with sponsors. The UILO provides the services of an experienced contract manager with access to contract review expertise for other academic research sites and the back up of legal expertise. Final review of clinical trial agreements rests with the Director of Department of Evaluation and Research Services who approves for signature rotation to the authorized VP and the clinical trial site.

The Summary of Requirements for Sponsored Research: Appendix 1 provides a template for Fraser Health requirements regarding standard wording in the clinical trial agreement.  Although designed for industry-sponsored research, the standards are also applied to the negotiation of agreements with academic sponsors with a few exceptions. See Industry Sponsored Research and Academic Sponsored Research for specific requirements and exceptions.

Find out more on the process of obtaining approval of CTA.