The contract is an important part of the clinical trial process that must be put in place before any trial activities occur. The contract review and negotiation process can occur simultaneously with the REB (whether HiREB, OCREB, or CTO) approval process, as the two processes occur independently of each other, although one can often inform the other.
A Clinical Trial Agreement (CTA) defines the responsibilities of all parties, the study, and how it will be performed. In addition to setting out responsibilities, these agreements outline who owns the data and results, who can publish, how confidential information is handled, and what happens when something goes wrong and how to remedy it, among other things.
HHS has a dedicated Research Contracts team that will negotiate the CTA with the Sponsor directly, or draft a CTA for use. Please see the Clinical Research Contracts page for more details.