Governing Participating Site Agreement for Tri-Council Funded Studies: Non-Regulated (g-PSA Non-Regulated)

The Accelerating Clinical Trials (ACT) Consortium Contract Working Group has developed the Governing Participating Site Agreement for Tri-Council Funded Studies: Non-Regulated (gPSA Non-Regulated).

Purpose:

This agreement is designed to streamline contract negotiations for inter-institutional clinical trials funded by the Tri-Council Agencies (CIHR, NSERC, SSHRC) that are not subject to Health Canada regulations. By establishing a pre-negotiated, legally binding framework, it aims to improve efficiency and accelerate study start-up timelines for academic and affiliated healthcare institutions/health authorities participating in these studies. It is designed to be compliant with Tri Council-funded studies, but can also be used in cases where (1) there is no funding or (2) there is a different funder whose funding terms are materially similar to Tri-Council Agencies

Agreement Structure:

The agreement includes two key components:
1) Agreement: A pre-negotiated, legally binding contract that outlines standard clauses and conditions. Parties agree to the terms in full unless specific changes are outlined in the accompanying Study Letter.

2) Study Letter: A project-specific document for each trial conducted under the agreement, which includes:

• Study-specific details and identifiers
• Optional clauses tailored to trial characteristics
• A section for any permitted modifications to the Governing Agreement

Key Benefits:

• Reduces the need for full re-negotiation for every new study
• Enables focused review of only study-specific details
• Promotes consistency in legal and governance terms across academic organizations and health authorities nationwide

Who Should Sign On:

• Institutions eligible to receive Tri-Council funding for interventional studies that are not regulated by Health Canada
• Any other Institution acting as participating sites in such studies

How to Become an Adoptee:

• Review the executed Governing Participating Site Agreement for Tri-Council Funded Studies: Non-Regulated.

• Complete the attached Joinder Form and return it to jencox@ohri.ca,  contracts@ohri.ca, and
  sierra.rosiana-easlick@phri.ca.

  Once you have returned the Joinder Form, you will receive a Word version of the Study Letter for use.