The ACT Contracts Working Group is a part of the CIHR- ACT Consortium grant and brings together legal and contracts experts from more than 60 academic institutions, research institutes, health authorities, hospitals, and affiliated research organizations across Canada. Through this national forum, legal and contracts specialists work collectively to reduce administrative burden, streamline processes, and support faster trial start-up for academic led research—ultimately improving Canada’s capacity to deliver timely, high-quality clinical research. More details on the Contracts Working Group are below.
To date, the group has developed four key agreements and tools to support and streamline contracting within academic health research partnerships.
Table of Contents
Governing Data and Biological Sample Transfer Agreement (gDSSA)
Use:
- Secondary use research
- Retrospective chart reviews
- Prospective chart reviews
- Data analysis
- The gDSSA is a binding agreement
- Parties sign on as adoptees to the agreement
- Includes a project-specific transfer letter
For more information about the gDSSA, including how to sign on as an adoptee, check out this page.
Sub-Site Template
Use:
- Clinical trials funded by sources other than Tri-Council
Nature of Agreement:
- As a template, the agreement uses adaptable language tailored to the specific research project
You can learn more and access a copy of the template here.
Governing Participating Site Agreement (gPSA) – Regulated
Use:
- Health Canada regulated, interventional clinical trials funded by Tri-Council
Nature of Agreement:
- The gPSA is a binding agreement
- Parties sign on as adoptees to the agreement
- Includes a project-specific transfer letter
For more information about the gPSA (regulated), including how to sign on as an adoptee, check out this page.
Governing Participating Site Agreement (gPSA) – Nonregulated
Use:
- Observational research funded by Tri-Council
Nature of Agreement:
- The gPSA is a binding agreement
- Parties sign on as adoptees to the agreement
- Includes a project-specific transfer letter
Agreement Summary
gDSSA | gPSA-Non Regulated | gPSA-Regulated | Sub Site Template | |
Master Agreement with Letters for each study | Yes | Yes | Yes | – |
Template Agreement | – | – | – | Yes |
Data and Samples sharing terms | Yes | Yes | Yes | Yes |
Optional funds sharing | Yes | Yes | Yes | Yes |
Recruitment and participation of patients for the study with participant interaction | No | Yes | Yes | Yes |
Randomization or intervention in the study | No | Yes | Yes | Yes |
Performance of a Phase I, II, III, or IV Health Canada Study | No | No | Yes | Yes |
Appropriate for tri-council funded studies | Yes | Yes | Yes | Yes |
Appropriate for industry funded research | Likely not | No | No | Yes |
Appropriate for industry sponsored research? | No | No | No | No |
Objectives of the Contracts Working Group:
- Accelerate the conduct and efficiency of clinical trials in Canada.
- Strengthen coordination among Canadian clinical trials, fostering collaboration and harmonization among trial units, networks, and stakeholders.
- Reduce cycle times in the negotiation and execution of clinical trial agreements.
- Develop master clinical trial agreement(s) and templates.
- Create additional tools, templates, and resources to streamline clinical trial contracts in Canada.
ACT Agreements Implementation Webinar
ACT Contracts Committee Co-Chairs, Breanne Stewart and Jennifer Cox, provide an overview of the available ACT agreements, helpful information on the implementation of these agreements, and answer related questions in the webinar below.
