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

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

Purpose:

This agreement is designed to streamline contract negotiations for inter-institutional, Health Canada–regulated clinical trials funded by the Tri-Council Agencies (CIHR, NSERC, SSHRC). 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.

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 regulated, interventional studies
  • Any other Institution acting as participating sites in such studies
Adoptees:

Click here to download a list of the current g-PSA Regulated adoptees.

How to Become an Adoptee:

The Accelerating Clinical Trials Consortium is generously supported through multi-year funding from the Canadian Institutes of Health Research’s Clinical Trials Fund, as part of Canada’s Biomanufacturing and Life Sciences Strategy to ensure that Canadians are well served by a national clinical trials network.