Interested in learning more about the UACT? Fill out the form below to receive a locked, annotated version of the UACT! Our team will provide additional guidance and support to help you effectively implement the UACT. Don’t miss this opportunity to gain valuable insights and make the most of the UACT in your work.
Join the growing network of organizations committed to streamlining clinical trials and advancing research in Ontario through the Universal Agreement for Clinical Trials.
The UACT Implementation Guide provides information to help you integrate UACT into your organization.
Have questions or need assistance? 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.
The UACT is a standardized clinical trial agreement developed by Clinical Trials Ontario (CTO) and the Ontario Leadership Table. It is designed to serve as a common contract for pharmaceutical drug trials conducted between sponsors (typically pharmaceutical companies) and institutions (such as hospitals and research centers) in Ontario.
The UACT was created to streamline the trial start-up process by reducing the time needed for contract negotiations, supporting Ontario’s goal of activating clinical trials within 45 days. It aims to simplify legal and administrative requirements, promoting efficiency and consistency across clinical trials.
The UACT is specifically intended for pharmaceutical drug trials sponsored by pharmaceutical companies. It includes a Clinical Trial Specific Agreement (CTSA) template to capture study-specific details.
The CTSA template is an appendix to the UACT that allows for study-specific details to be documented. This keeps the primary agreement consistent while accommodating unique elements of individual trials.
No, any institution and sponsor implementing the Ontario UACT can use it for their industry-sponsored pharmaceutical drug trials.
The current UACT is drafted specifically for pharmaceutical company-sponsored drug trials that do not involve a CRO. Additional agreements may be developed based on community needs and feedback at a future time.
No, while the UACT supports the 45-day trial activation goal, it primarily aims to streamline the contracting process, regardless of specific activation timelines.
The UACT is intended to be implemented “as is”. Only minor administrative details such as the parties’ legal names, signatories’ names and relevant contact information should be added. Any required trial-specific information can be included in the appended Clinical Trial Specific Agreement (CTSA) under Section 8. This section may be used on a study-by-study basis to accommodate unique terms which are specific to the protocol that is the subject of the CTSA. Negotiation of CTSA revisions should be kept to a minimum.
No, a budget template is not provided. Sponsors will continue to share their own budget templates for negotiation purposes.
Please direct questions or suggestions to the quickstart@ctontario.ca.
Consider engaging senior leaders and other internal stakeholders early and often to inform them about the value-added by participating in the UACT initiative. Providing metrics on important areas such as shorter time to trial activation, increased availability of new treatments, reduced contract review / negotiation costs can assist in underscoring the benefits of adopting the UACT.
