Provincial Tools

Data Access for Research

As part of its government mandate, CATALIS has been tasked by the research branch of the Ministère de la Santé et des Services sociaux (MSSS) to support the operationalization of Bill 5 on health and social services information (AHSSI) (before and after it takes effect on July 1, 2024).

This mandate, which also mobilizes the public/private experts of the CATALIS Network, is intended to facilitate and regulate access to health information for research purposes in order to accelerate the development of innovative treatments for the well-being of patients in Quebec.

As part of this mandate, CATALIS has been asked to work on the following:

1. Consult with 10 or so health and social services bodies (HSSBs) identified by the MSSS to (1) assess the current state of access to health information (HI) for research purposes, (2) identify issues to be resolved, and (3) make recommendations prior to implementation of the AHSSI. Following meetings, CATALIS produced an initial consultation report (post-Bill 25 and pre-Bill 5) which was submitted to the MSSS for analysis.

See Rapport de CATALIS – Consultation des ESSS – March 2024 (Fr) (in French only)

Following submission of the report, a sequential action plan was developed with the MSSS to (1) identify and plan the different steps required to orchestrate provincial implementation with harmonized processes for accessing HI for research purposes, and (2) provide for continuous improvement of provincial processes based on automated performance indicators.

2. Develop flow diagrams to map the path of an access request for attached researchers (in Health and Social Service Bodies (HSSBs)) and other researchers (private and public) in accordance with the processes outlined in the Act respecting health and social services information (AHSSI). The following flow diagrams were produced:

• Process for requesting access to health information (HI) in accordance with the AHSSI:
  • Which HI process applies to me?
  • Access to HI for RESEARCHERS ATTACHED to an HSSB
  • Access to HI for OTHER (PUBLIC) RESEARCHERS
  • Access to HI for OTHER (PRIVATE) RESEARCHERS

3. Support the MSSS and HSSBs in the development of common provincial tools to facilitate access to health information for research purposes. The following common provincial tools have been developed for the AHSSI access process since July 1, 2024:

• Privacy Impact Assessment (PIA) form templates:
  • Standard PIA Form
  • Simplified PIA form (low risk – e.g., pre-selection of participants for clinical trials)
• PIA Report template
• Access Agreement template
• Guide for completing the PIA Form and Report – being developed by members of the PIA working committee, made up of HSSB representatives and coordinated by the MSSS

4. Ensure ongoing consultation with professionals in support of access to HI for research purposes through a Data Advisory Committee comprising the 23 member healthcare institutions of the CATALIS Network, in order to optimize provincial processes and tools to facilitate research.

If you have any questions, please contact info@catalisquebec.com.

Regulatory Standards: FDA 1572

CATALIS and its network of private and public partners have prepared a memo which serves to clarify the requirements for the signing of form FDA 1572 in both Quebec and the rest of Canada as applicable to clinical trials.

Although signing FDA 1572 is a regulatory obligation and thus a contractual requirement in agreements for sites in the United States that are participating in clinical trials regulated by the Food and Drug Administration (FDA), sites located within Quebec’s health and social services network must be exempt from this requirement and from the requirements relating to research ethics boards’ composition and operating methods.

Therefore, to maximize compliance requirements, sponsors must proceed in one of the two following ways:

1. 1. When Quebec sites are listed in the Investigational New Drug (IND) application:

Submit a waiver request pertaining to the signing of FDA 1572 and to the requirements relating to research ethics boards’ composition and operating methods for any such site. (21 CFR 312.

2. When Quebec sites aren’t listed in the IND application:

Since clinical trials performed in Canada must be conducted according to the principles outlined in ICH BPC E6 and that an inspection of Canadian sites by the FDA may occur, the requirements pertaining to signing FDA 1572 and the requirement relating to research ethics boards’ composition and operating methods would therefore no longer apply to any such site. (21 CFR 312.120)

In both cases, qualified researchers at sites located within the Quebec health and social services network no longer sign FDA 1572 forms.

Download the Memo for Sponsors:

English version / French version

Update – Standard Operating Procedures (SOPs) for the Ethical Review of Clinical Research Projects in Quebec

CATALIS and its Network of public and private partners have implemented the second version of the REB SOPs. These SOPs are a Quebec adaptation of the N2 Canada SOPs. The new version, orchestrated by CATALIS, was developed in collaboration with its Ethics Advisory Committee, composed of about fifteen representatives of Research Ethics Boards (REBs) in the Quebec Health and Social Services Network, in order to incorporate the latest changes in the regulatory framework. These new SOPs (v2) have been reviewed by the ministère de la Santé et des Services sociaux du Québec to ensure that they meet ministerial requirements.

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 

Download all documents: (zip file)

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If you have any questions, please contact info@catalisquebec.com.

Standards for Ethics Reviews: Informed Consent Forms (ICFs)

CATALIS and its network of public and private partners have prepared standard wordings for the legal clauses that must be included in the consent forms for clinical trials conducted within the RSSS.

The objective is to use these standard legal clauses in the relevant consent forms by default and thereby improve the efficiency of the process involved in drafting these forms and their approval by the RSSS’ research ethics boards. Ultimately, the clauses are intended for those who are being asked to participate in clinical trials.

Dissemination of the updated “Standard legal clauses for information and consent forms for clinical trials” – CATALIS (catalisquebec.com)

Download the standard legal clauses of the information and consent forms for clinical trials:

English version/French version

Standards for Evaluating Contracts

Coordinated by CATALIS, new provincial best practices reference tools aimed at speeding up the evaluation process for clinical research contracts with private companies, have been developed by representatives of the Health and Social Services Network (RSSS) and the Research Department of the ministère de la Santé et des Services sociaux (MSSS).

Aimed at pharmaceutical companies wishing to conduct clinical trials in Quebec, the Statement on optimizing contract negotiation processes confirms the regulatory requirements applicable in RSSS institutions. It now includes the new provisions of the French Language Charter.

The Statement also suggests the use of a provincial model confidentiality agreement (mCDA) and a pan-Canadian model clinical trial agreement (mCTA), which will be accepted as is if used without modification by the private company.

The CATALIS Network also developed a memo to clarify the responsibilities of stakeholders in the context of activities carried out in participants’ homes.

Consult the new provincial tools:
– Statement
– Provincial mCDA: French version, bilingual version, English version
– Provincial mCTA: French version, bilingual version, English version
– Memo on activities in participants’ homes

For more information, please contact info@catalisquebec.com.

Clinical Research Training

CITI-Canada Training

CATALIS is proud to partner 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.

CATALIS is now N2 Canada’s new provincial representative; we will actively participate in various panCanadian activities, including organizing regional events with N2 Canada.