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

Nagano Data Processing System

CATALIS and its network of public and private partners worked together to optimize the Nagano data processing system to ensure that this multifunction institutional clinical trial planning and management platform would be used to its full potential by institutions belonging to the réseau de la santé et des services sociaux (RSSS), Quebec’s public health and social services network.

This section presents the objectives pursued and the projects carried out.

Roll out the harmonization and synchronization of Nagano’s inter-institutional platforms to facilitate the administrative management of multicentre clinical trials and contribute to establishing a standardized provincial database. 

CATALIS Quebec announces the rolls out the 2nd phase of Nagano clinical trial evaluation management system synchronization in the Quebec’s health and social services institutions – CATALIS

Automation of the collection of institutional performance indicators for clinical trials

A new tool for monitoring clinical research performance in Quebec – CATALIS (

Facilitate the implementation of automated public databases (pending)

Clinical trial database

Using data from the Nagano system, CATALIS is coordinating the development of an automated, bilingual (French-English) public database of clinical trials in Quebec to facilitate the recruitment of clinical trial participants. When available, the online platform will, among other things, provide health professionals, researchers, and other stakeholders (including the public) with access to clinical trial information.

The Ministry of Health and Social Services issued a Statement of Principles on May 9, 2022 which stated that if a sponsor refuses to have non-confidential information about the clinical trials for which it is the sponsor appear in this database, it must explicitly deregister from this initiative by: 1) including a clause to this effect in contracts with RSSS institutions; 2) ensuring that each researcher confirms this deregistration as part of their project proposal to the institution.

Clinical research expert database

An automated database of clinical research experts will also be developed to facilitate the pairing of clinical trials with provincial experts.

Facilitate the implementation of the Nagano PLUS module (CTMS) to facilitate clinical trials’ budget management and the invoicing of sponsors (pending)

The new Nagano PLUS module will be available to institutions participating in the FAST TRACK evaluation service, which facilitates the preparation, assessment, and invoicing of clinical research project budgets.

Once the project is completed, this new multicentric module (which will contain a list of common procedures) will also allow healthcare institutions to obtain institutional and provincial medians for each procedure related to the conduct of clinical trials.

Shared Investigator platform

SIP is a life sciences SaaS solution that streamlines clinical trials to improve the speed of drug discovery. The platform aims at standardizing clinical trial documents, training and start-up activities into a single shared environment to reduce costs and increase efficiency. It is currently use by 7 of the largest global biopharmaceutical companies and + 250,000 users across 100 countries worldwide and in operation at over 32,000 trial-ready sites.

The following training courses are intended for users of the sites. Available in French only.

  1. Navigation, Profil, CV, Délégation 
  2. Profil du site, CÉR  
  3. Documents et autres activités 

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.

  1. 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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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 (

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:
– 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

Standards for Remote Monitoring

The pandemic created difficulties in accessing facilities, making clinical trial remote monitoring activities much more complex.

To facilitate the implementation of solutions, CATALIS and its network of public and private partners developed a guide on best practices for remote monitoring of data in health and social services institutions.

This document aims to provide guidelines for alternatives and recommendations for planning, implementing, and performing remote data monitoring activities within the scope of process monitoring of clinical trials and their deliverables. The following components of remote data monitoring are the subject of this document:

  • Remote access to electronic medical records
  • Remote access to hard copies of source documents (note: Ensure that the digitization of hard copy source documents complies with information security best practices {secure and restricted environment}, considering the data sensitivity level)
  • Certified copy process
  • General considerations for remote monitoring of data


Download the guide intended for institutions (in French)


For more information, please contact

Clinical Research Training

  1. 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.

Good Clinical Practices (GCP)

This course is a program containing ten modules on good clinical practice tailored to clinical trials. The training focuses on the International Council for Harmonization guidelines (ICH E6(R2) and on the regulations applicable in Canada such as Health Canada Division 5 and the Tri-Council Policy Statement.

The course is available in English and French and is recognized by TransCelerate BioPharma.

Take the course by clicking here (available in English, French, Spanish, Korean, Finnish and German).

Human Subjects Research – Biomedical

This course consists of nine modules and provides historical and current information on regulatory and ethical issues important to conducting research involving human subjects. It focuses on the introduction of ethical standards and regulations in research; research ethics boards and the ethics review process; harms and benefits; the informed consent process; privacy and confidentiality; conflicts of interest and particular questions on designing research.

The Foundations modules are intended for anyone involved in biomedical research studies involving human subjects.

Take the course by clicking here (available in English, Spanish and Korean).

Responsible Conduct of Research

This course covers the core norms, principles, regulations, and rules governing the practice of research in Canada. The modules cover topics such as introduction to RCR; ethical responsibilities of the researcher; authorship; collaborative research; conflicts of interest; research involving human subjects; research misconduct; using animal subjects in research.

This course in intended for researchers, students, and others from various disciplines and fields.

Take the course by clicking here (available in English and Korean).

Transport of Dangerous Goods/International Air Transport Association (TDG/IATA)

This training is essential to ensure that anyone conducting research using hazardous materials, agents or devices complies with all applicable laws. The course consists of six modules and covers the following topics: introduction; classification; safety seals; packaging and containment, marking and labelling; documentation; ERAP and accidental releases.

This course is suitable for a wide range of audiences ranging from researchers working in laboratories handling dangerous goods to clinical research staff or anyone involved in the transport of dangerous goods and/or international air transport.

Take the course by clicking here (available in English).

Health Canada Division 5

The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in clinical trials in Canada involving human subjects. More specifically, Part C of Division 5 of the Regulations deals with drugs for clinical trials involving humans.

Health Canada states that the qualified investigator must ensure compliance with the International Conference on Harmonisation (ICH-GCP E6) Regulations and Good Clinical Practice Guideline (integrated into the Regulations) by any person involved in the conduct of the clinical trial on their site. As such, there must be evidence of adequate training of personnel involved in these processes. Successful completion of this CITI-Canada course can be used as evidence of Division 5 Regulations training. This Division 5 course covers all research conducted under Division 5 Regulations and provides practical solutions and methods for complying with the Regulations. This course is available in English and in French.

Take the course by clicking here (available in English, Chinese, Korean and Spanish).

Clinical Research Coordinator (CRC)

This course was developed for CITI-Canada to provide learners with a fundamental understanding of the elements of a CRC’s role. This course is designed as a simple role-based training for learners requiring basic CRC training or for organizations requiring onboarding training for new CRCs. It provides learners with a foundation that goes beyond (but is directly related to) the ethics of biomedical research and good clinical practice course offered by N2/CITI-Canada.

CRC Course Modules:

  1. Overview
  2. Planning Research
  3. Funding, Financial Management, and Budgeting
  4. Working with the Institutional Review Board (IRB)
  5. Protocol Review and Approvals
  6. Principal Investigator (PI) Responsibilities
  7. Clinical Research Coordinator (CRC) Responsibilities
  8. Sponsor Responsibilities
  9. Informed Consent
  10. Site Management, Quality Assurance, and Public Information
  11. CRC Resources
  12. Overview of the Clinical Trial Agreement
  13. Coordinating Studies Regulated by the U.S.

This course is designed for CRCs, investigators, and other clinical research professionals. It can also be useful for those who are pursuing a career in clinical research. This course is recommended for clinical research personnel with 1 to 2 years of experience in clinical research.

Take the course by clicking here (available in English).

Good Data Management (GDM)

This course has 3 objectives:

1. Review Data, Source Documents and Good Documentation Management
2. Review Case Report Forms (CRFs), Electronic Data Capture (EDCs) and Good Data Management
3. Review Internal Query Resolution Process

How to register for the course:

  • Click here 
  • Create new account (link on bottom of screen)
  • Go to your email inbox to verify the new account
  • Go back to URL click on ‘courses’ on left hand navigation pane
  • Click course name and then ‘enrol’
  • View the course by clicking presentation
  • Complete quiz and print your certificate of completion (if desired)