One Year Later
In the fall of 2024, Ontario made history by launching a universal agreement for clinical trials (known as the UACT or the “U-ACT”), which serves as a pre-negotiated contract between research institutions and sponsors for industry-funded clinical trials. Led by the Ontario Leadership Table for Clinical Trials and Clinical Trials Ontario (CTO), this landmark achievement was a first step in the province’s bold ambition of a 45-day clinical trials activation timeline. Now one year later, we’re looking at what’s new with the UACT.
Gaining Momentum: Growing List of UACT Users
Since announcing the contract at the 2024 Clinical Trials Ontario conference and broadly promoting with the help of the Ontario Hospital Association and other partners throughout 2025, a growing list of hospitals, research institutions and pharmaceutical companies have signed on.
Today, 21 organizations are implementing the Ontario UACT to streamline and speed-up their clinical trial collaborations.
Ironing Out Wrinkles: New Version Available
From the outset, the Ontario Leadership Table for Clinical Trials and CTO committed to collaborating on a six-month review of the UACT. The Leadership Table’s Clinical Trial Agreement Committee had worked tirelessly to develop the terms of the UACT, and there was no intention to undo or re-open terms that were previously included through consensus. However, they wisely recognized the potential for wrinkles once the UACT was put into use. The six-month review considered feedback on arising legal, regulatory and practical challenges.
A new version of the UACT is available to use moving forward. At this time, CTO and the Ontario Leadership Table for Clinical Trials do not anticipate future iterations.
What’s New and What’s Next?
Click the arrows to find details about what’s new with the UACT, and what it means for UACT partners moving forward.
What’s new with the UACT?
- A term was added addressing responsibility for damage caused to Sponsor-loaned equipment, as well as a footnote reminder to consider requirements for service and maintenance of Institution-owned equipment.
- Sponsor’s requirement to submit to Institution annual tax form was deleted.
- The requirement to maintain the confidentiality of Sponsor Confidential Information was extended to ten years following expiry or termination of the relevant CTSA.
- Sponsor’s requirement to notify Institution and Principal Investigator of a privacy, confidentiality, or security breach was extended from one Business Day to 48 hours, and its obligations to Institution following the breach were finessed.
- Sponsor’s ability to terminate a CTSA with immediate effect upon receipt of a debarment, disqualification, or suspension notice was added.
- A term to explicitly identify which Party must provide notice to Principal Investigator of a proposed UACT amendment was added.
- A placeholder was added for instances where a Sponsor requires a listing of Clinical Trial Site(s).
- Amendments to address legal/regulatory concerns relating to fully anonymized Clinical Trial Data were added. The definitions of Clinical Trial Data and Personal Information were amended.
- An explicit reference to the REB was added in the list of indemnities and a placeholder footnote was also added to identify that where Institution is a research institute, it may request to explicitly name the participating hospitals and their REBs.
- A footnote was added to clarify that section 8 of the CTSA may be used to accommodate unique terms specific to the applicable Study which may include, but are not limited to, the items noted in the other footnotes to the CTSA.
What are the next steps?
This 2025 UACT is the current active version and is intended for use by all parties entering new contractual arrangements, from this point forward.
If you have already executed the 2024 version, here are some options to consider moving forward:
- Given the minimal list of updates, organizations may choose to simply maintain the already-signed agreement, without amendment.
- Sponsors that wish to maintain the already-signed agreement but want to benefit from the deletion of the annual tax form submission requirement may request a waiver from the relevant institution.
- Parties may enter into an Amending Agreement, addressing some /all of those 2025 UACT updates of most significance to them. A sample Amending Agreement template is available on the UACT webpage of CTO’s website.
Additional information and guidance about implementing these options are available in the UACT FAQs listed here.
Thank You!
CTO is sincerely grateful to the many members of the Ontario Leadership Table for Clinical Trials who have offered their support and thoughtful engagement on the development of the UACT.
We continue to be encouraged by the positive responses received from sponsors and institutions alike. CTO will continue promoting the UACT and working with institutions and sponsors throughout Ontario to adopt the agreement and move forward with a streamlined tool that supports faster start-up timelines.
Are You New to the UACT?
There is a wealth of information and guidance available about the UACT on Clinical Trials Ontario’s website, including a detailed Implementation Guide and FAQs. Find information and answers, and download a copy of the 2025 annotated agreement here.
If you have questions, or are ready to get started, please reach out to us at quickstart@ctontario.ca. Our team is here to help with any inquiries you may have about the Ontario Universal Agreement for Clinical Trials or other QuickSTART tools and initiatives.