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. The gPSA-Regulated has provisions appropriate for using a study drug or device in an academic clinical trial.
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
How to Become an Adoptee:
- Review the executed Governing Participating Site Agreement for Tri-Council Funded Studies: Interventional and 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.
| The Research Institute of the McGill University Health Centre |
| Kingston Health Sciences Centre Research Institute/Kingston Health Sciences Centre |
| MICYRN |
| CHU de Québec-Université Laval |
| The Hospital for Sick Children (Sick Kids) |
| Holland Bloorview Kids Rehabilitation Hospital |
| IWK Health |
| Shared Health |
| Hamilton Health Sciences Corporation |
| Research St. Joseph’s – Hamilton o/a The Research Institute of St. Joe’s Hamilton |
| Bruyére Health Research Institute |
| London Health Sciences Centre Research Inc. dba. London Health Sciences Centre Research Institute (LHSCRI) |
| Lawson Research Institute (Lawson) |
| Ottawa Hospital Research Institute |
| Dalhousie University |
| The University of British Columbia |
| Provincial Health Services Authority (on behalf of BC Cancer) |
| Provincial Health Services Authority (on behalf of BC Children’s Hospital and BC Women’s Hospital & Health Centre) |
| Providence Health Care Society |
| Vancouver Coastal Health Authority |
| University of Alberta |
| University of Manitoba |
| McMaster University |
| Fraser Health Authority |
| Vancouver Island Health Authority |
| Unity Health Toronto |
| University Health Network |
| The University of Western Ontario |
| Sinai Health System |
| Queen’s University at Kingston |
| Institut du Savoir Montfort |
| Providence Care Centre |
| Université Laval |
| Sunnybrook Research Institute |
| CancerCare Manitoba |
| Health Sciences North Research Institute |
| Winnipeg Regional Health Authority |
| SANTÉ QUÉBEC, legal person established in the public interest constituted under an Act respecting the governance of the health and social services system, (CQLR c. G-1.021), acting through its institution CENTRE HOSPITALIER DE L’UNIVERSITÉ DE MONTRÉAL (CHUM), located at 850 Saint-Denis St, Pavilion S, Montréal, Quebec, H2X 0A9, Canada, represented for the purposes hereof by Sylvain Baillet, Director of Research and Innovation of CHUM, duly authorized in accordance with Santé Québec’s by-laws |
| Trek Health Research |
| Thunder Bay Regional Health Research Institute |
| Thunder Bay Regional Health Sciences Centre |
| SOUTHLAKE HEALTH |
| Provincial Health Authority, operating as NL Health Services |
| Oak Valley Health |
| Institut de recherches cliniques de Montréal |
| CISSS de Chaudière-Appalaches |
| Santé Québec – Centre intégré de santé et de services sociaux de l’Outaouais |
| CIUSSS l’EST-del’Ile-de-Montreal |
