CATALIS and its Network of public and private partners are developing simple and effective shared services and tools designed to maximize Quebec institutions’ clinical research performance, specifically pertaining to launching and conducting of clinical trials.
For more information, please contact info@catalisquebec.com.
Memo: FDA Form 1572 – Requirements for Canada and Quebec
To: Research teams and sponsors
Description: The FDA Form 1572 – Requirements for Canada and Quebec memo clarifies the requirements for signing Form FDA 1572 in Quebec with respect to clinical trials.
Links to download the document(s): English version / French version
Memo: regarding Regulation (EU) No. 536/2014 and its application in Quebec
To: Sponsors
Description: The memo clarifies Canadian and Quebec requirements under Regulation (EU) No. 536/2014 with respect to the conduct of clinical trials in Quebec institutions.
Links to download the document(s): English version / French version
Standard legal clauses and standardized provisions for information and consent forms (ICFs) for clinical trials
To: Research teams, sponsors and Research Ethics Boards
Description: The standard legal clauses cover most of the legal information that must be disclosed to individuals who are asked to participate in clinical trials during the consent process.
For their part, the standardized provisions group together formulations deemed to comply with the requirements of research ethics boards. Their use as-is in the relevant consent forms facilitates and optimizes both the development of these documents and their approval by Research Ethics Boards (REBs) across the health and social services network.
The summary document titled Update to Standard Legal Clauses and Other Standardized Clauses presents the changes to the legal clauses (2021 version), which will be required by Research Ethics Boards across the health and social services network, in order to ensure their compliance with the current legal framework, pending the adoption of a new version of the standard legal clauses.
Links to download the document(s):
Standard legal clauses (2021 version): English version/French version
Summary Document Update to Standard Legal Clauses and Other Standardized Clauses (2025 version): English version/French version
If you have any questions, please contact info@catalisquebec.com.
Standard Operating Procedures (SOPs) for Research Ethics Boards
To: Health and Social Services Network Research Ethics Board Staff
Description: These SOPs, intended for REB members and staff, are a Quebec adaptation of the N2 Canada SOPs. They are reviewed by Quebec’s Ministère de la Santé et des Service sociaux to ensure they meet departmental requirements.
Links to download the document(s):
100 – General Administration
101.002 – Authority and Purpose
102.002 – Research Requiring REB Review
103.002 – Education and training
104.002 – Management of REB Support Staff
105A.002 – Conflicts of Interest – REB Members and Support Staff
105B.002 – Conflicts of Interest – Researcher
105C.002 – Conflicts of Interest – Board of Directors
106.002 – Signatory Authority
107.002 – Use and Disclosure of Personal Information
108.002 – Operating Procedures Maintenance
200 – REB Organization
201.002 – Composition of the REB
202.002 – Management of REB Membership
203.002 – Duties of REB Members
300 – Functions and Activities
301.002 – REB Submission Requirements and Administrative Review
302.002 – REB Meeting Administration
303.002 – Document Management
400 – Research Evaluation
401.002 – REB Review Decisions
402.002 – Delegated Review
403.002 – Initial Review – Criteria for REB Approval
404.002 – Ongoing REB Review Activities
405.002 – Annual Review – Renewal of REB Approval
406.002 – Suspension or Terminaison of REB Approval
407.002 – Research Completion
500 – Review Requiring Special Consideration
501.002 – REB Review During Publicy Declared Emergencies
502.001 – Biobanks (TBA) – Pending
503.001 – Multisite Research – Pending
504.001 – Assisted Procreation Activities
600 – ERC Communications and Notifications
601.002 – Communication of REB Decisions
700 – Informed consent
701.002 – Recruitment and Informed Consent Requirements
800 – Responsibilities of researchers
801.002 – Researcher Qualifications and Responsibilities
900 – Quality Control
901.002 – Quality Assurance
903.002 – Non-Compliance with the Responsible Conduct of Research
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If you have any questions, please contact info@catalisquebec.com.
Statement on optimizing the contract negotiation process with pharmaceutical companies
To: Sponsors
Description: This statement confirms the regulatory requirements applicable to institutions across the health and social services network, as well as the new provisions of the Charter of the French Language.
Links to download the document(s):
Statement: English version / French version
Provincial Model Confidentiality Agreement (mCDA)
To: Sponsors
Description: Use of the Provincial Model Confidentiality Agreement is recommended by the Statement on optimizing the contract negotiation process(available in French only). If a sponsor submits this contract in its original form without any modifications, public health institutions in Quebec will accept it as is.
Links to download the document(s):
Provincial mCDA: English version / bilingual version / French version
Provincial Model Clinical Trial Agreement (mCTA)
To: Sponsors
Description: The Pan-Canadian Model Clinical Trial Agreement is developed from the Canadian Clinical Trials Coordinating Centre (CCTCC) model adapted to the Quebec regulatory context. If a sponsor submits this contract in its original form without any modifications, public health institutions in Quebec will accept it as is.
Links to download the document(s):
mCTA: English version / bilingual version / French version
Standard of care
To: Sponsors and research teams
Description: This document defines criteria for determining which drugs and procedures can be considered “direct research costs”. Its purpose is to support budget negotiations by providing a shared evaluation framework.
Links to download the document(s): version anglaise/ version française
Memo on activities in participants’ homes
To: Sponsors
Description: This memo clarifies stakeholders’ responsibilities with respect to activities carried out in participants’ homes.
Links to download the document(s):
mCTA: English version / French version
Memo on the transition of institutions to Santé Québec
To: Sponsors
Description: This document clarifies the impact of the merger of health and social services institutions resulting from the creation of Santé Québec on the negotiation, conclusion and signing of new contracts. It also clarifies the naming of institutions, as approved by Santé Québec, which must be used in all agreements signed since December 1, 2024.
Links to download the document(s):
Memo: English version / French version
For more information, please contact info@catalisquebec.com.
Questionnaire to Support Pharmacy Department Feasibility Assessment for Clinical Trials with Drugs
To: Sponsors and research teams
Description: This questionnaire was designed to expedite the authorization of a research project by providing the research pharmacy with the detailed information needed for its feasibility assessment, in addition to the study documents. It must be completed by the sponsor and submitted for evaluation by the research teams.
Links to download the document(s):
Questionnaire: English version / French version
L2 and CITI-Canada training
CATALIS has partnered with N2 Canada to offer CATALIS network member health institutions free access to a shared training platform designed to ensure the conduct of high-quality research. Through N2 Canada, institutions have access to the CITI-Canada (Collaborative Institutional Training Initiative) training platform.
Please refer to N2 Canada’s comprehensive training offering available to institutions through the partnership with CATALIS.
To access N2 courses, please contact the designated person responsible for providing access at your institution.
Training courses developed by the CATALIS Network
These courses co-created with members of the CATALIS Quality and Training Advisory Committee address a need expressed by the members of the Network to offer short, accessible and engaging content in order to harmonize clinical research practices. They are available for institutions in the N2 digital learning environment. To access these courses, please contact the designated person responsible for providing access to the N2 platform at your institution.
Quality management
Description: This training provides an understanding of the basic principles of quality, compliance and continuous improvement in research.
Delegation of tasks
Description: This training explores in depth the delegation of tasks within a research protocol. It highlights the importance of well-structured delegation to ensure rigour and compliance of clinical studies, and outlines the key steps for organizing the delegation of tasks in accordance with regulatory requirements. These include the identification of tasks that can be delegated, the appropriate selection of appropriate team members, and the rigorous documentation of delegation using adapted logs. The training also covers the management of specific situations, such as changes in personnel or adjustments over the course of the study. Concrete examples and model logs are provided to facilitate implementation.
ALCOA + principles and data correction
Description: This training introduces good documentation practices in accordance with ALCOA + principles. Adherence to these principles helps ensure data integrity throughout a study. The training also covers the application of these principles on a day-to-day basis and the proper correction of source documents in the event of errors.
Study data management
Description: This training presents the fundamentals of research data management. It explains how to distinguish the types of study data and helps to understand the concepts of source and derived data, as well as to ensure data traceability and reconstructibility. The training also covers good document-copying practices and the life cycle of documentation relating to a study.
Administrative management of research – Checklist
To: Research centres
Description: This tool was developed by a working sub-group of the CATALIS Québec Quality and Training Advisory Committee, dedicated to the administrative management of research. Presented as a checklist, it is intended to guide institutions – particularly their “research office” or equivalent – wishing to undertake research activities involving human participants, by helping them identify key elements of the administrative and logistical structure needed to guide the research teams.
Links to download the document(s): French version (available in French only)
Regulatory inspections in clinical research – Guidance
To: Research teams
Description: The purpose of this guide, developed by CATALIS Québec with the support of members of the CATALIS Network, is to help research centres better prepare by sharing proven best practices and avoiding common pitfalls. Designed as a tool kit, it allows you to select relevant information based on your needs or your current stage. It provides a comprehensive and practical resource for navigating all stages of an inspection, from understanding the regulatory framework to taking action after the visit.
Links to download the document(s):
- Guide: French version (available in French only)
- Supporting list: French version (available in French only)
- Appendices: French version (available in French only)
For more information, please contact info@catalisquebec.com.