Resources

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.

The CATALIS network’s new FAST TRACK Evaluation Service has made it possible, in its pilot phase, to reduce the authorization time for an industry-funded clinical trial to 8 weeks, or by nearly 75%.

Through the FAST TRACK Evaluation Service, CATALIS hopes to contribute to the optimization of the clinical research environment in Quebec and to the acceleration of the development of innovative treatments, for the benefit of patients in the province.

Currently, CATALIS is piloting the FAST TRACK Evaluation Service until the fall of 2022 with the pharmaceutical companies in its network and participating healthcare institutions:

Impressive first results

If you are a pharmaceutical company or a contract research organization (CRO) and would like more information, please contact us at info@catalisquebec.com.

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 (catalisquebec.com)

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.

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. 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.

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

CATALIS and its network of public and private partners have implemented SOPs to harmonize research ethics boards’ administrative practices. These SOPs are a Quebec adaptation of the N2 Canada SOPs.

Standard operating procedures for the ethical review of clinical research projects in Quebec – CATALIS (catalisquebec.com)

Table of Contents – SOPs Standard operating procedures
100 – General administration (101-108)
101.001 – Authority and Purpose
102.001 – Research Requiring REB Review
102.001 – Research Requiring REB Review
104.001 – Management of REB Support Staff
105A.001 – Conflicts of Interest – REB Members and Support Staff
105B.001 – Conflicts of Interest – Researcher
105C.001 – Conflicts of Interest – Board of Directors
106.001 – Signatory Authority
107.001 – Use and Disclosure of Personal Information
108.001 – Standard Operating Procedures Maintenance
200 – REB Organization (201-204)
201.001 – Composition of the REB
202.001 – Management of REB Membership
202.001 – Management of REB Membership
204.001 – REB Support Staff Serving as REB Members (TBA) – Pending
300 – Functions and Operations (301-303)
301.001 – REB Submission Requirements and Administrative Review
302.001 – REB Meeting Administration
303.001 – Document Management
400 – Reviews of Research (401-409)
401.001 – REB Review Decisions
402.001 – Delegated Review
403.001 – Initial Review – Criteria for REB Approval
404.001 – Recruitment and Informed Consent Requirements
405A.001 – Ongoing REB Review Activities
405B.001 – Continuing Review (TBA) – Pending
406.001 – Annual Review – Renewal of REB Approval
407.001 – Suspension or Termination of REB Approval
408.001 – Research Completion
409.001 – Communication of REB Decisions
500 – Reviews requiring Special Consideration (501-504)
501.001 – REB Review During Publicly Declared Emergencies
502.001 – Biobanks (TBA) – Pending
503.001 – Multisite Research – Pending
504.001 – Research on Assisted Reproductive Technologies (TBA) – Pending
600 – Researcher Qualifications and Responsibilities (601)
601.001 – Researcher Qualifications and Responsibilities
700 Quality Control (701-702)
701.001 – Quality Assurance
702.001 – Non-Compliance with the Responsible Conduct of Research
MUHC REB-SOPs Table of Concordance with N2/Careb SOP Codes
Glossary of terms – Research Ethics Board Standard Operating Procedure

Download all documents: (zip file)

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

CATALIS and its network of public and private partners have facilitated the implementation of documents serving to optimize the contract negotiation process with private industry for the conduct of clinical trials.

Statement – Clinical Research Conducted by a Private Sector Sponsor: Statement on Optimizing the Contract Negotiation Process (for Sponsors)

The Statement is intended for pharmaceutical companies who want to conduct, in collaboration with health and social services network (RSSS) institutions, clinical trials that they sponsor. It is designed to confirm the non-negotiable regulatory requirements applicable in Quebec and provide details regarding certain other contextual elements specific to the RSSS. The Ministry of Health and Social Services reiterates the importance that all RSSS institutions apply the principles set out in the Statement in order to standardize contract revisions and support a common message to the various pharmaceutical companies sponsoring clinical trials.

Download the English Statement/Download the French Statement

A Guide to Best Practice for Clinical Research Contracts with Private Sector Sponsors (for Institutions)

The Guide is a reference, information, and support tool intended solely for internal use by RSSS institutions and is therefore available exclusively through the RSSS’ intranet.

For more information, please contact info@catalisquebec.

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 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.

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.

Human Subjects Research – Course Focused on Social and Behavioral Components

This course contains thirteen modules and provides foundational information on ethical human subject research in social, behavioural, and educational fields. The modules include topics such as history and ethical principles; defining research with human subjects; the Tri-Council Policy Statement: ethical conduct for research Involving humans, 2^nd edition and reviewing social sciences and behavioral research; assessing risk in social and behavioural sciences; informed consent; privacy and confidentiality; research with children; research in vulnerable circumstances; Internet-based research and conflicts of interest.

The foundations modules are intended for anyone involved in social, behavioural, and educational research studies or who have responsibilities for setting their policies and procedures.

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.

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.

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.

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.

Introduction to Privacy and Security of Personal Health Information in the Canadian Health Research Environment

The introductory course on the privacy and security of personal health information in the Canadian health research environment was developed for CITI-Canada to provide learners with an understanding of privacy and security requirements for human health research. This course provides essential information, based on accepted privacy and security standards and regulatory requirements, for the appropriate collection, use, dissemination, retention, and destruction of PHI in the health research environment. Course material will address requirements outlined in guidance documents such as the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS) as well as federal, provincial, and territorial legislation. The most important source of federal privacy legislation, which will be this course’s primary focus, is PIPEDA, the Personal Information Protection and Electronic Documents Act.

This course is suitable for anyone who administers, reviews or conducts health research (that is, research that involves but is not limited to collecting health data, as is the case in clinical research).

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:

Overview
Planning Research
Funding, Financial Management, and Budgeting
Working with the Institutional Review Board (IRB)
Protocol Review and Approvals
Principal Investigator (PI) Responsibilities
Clinical Research Coordinator (CRC) Responsibilities
Sponsor Responsibilities
Informed Consent
Site Management, Quality Assurance, and Public Information
CRC Resources
Overview of the Clinical Trial Agreement
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.

Training on the Shared Investigator Platform

Three new training modules are now available to facilitate the use of the Shared Investigator Platform.

Part 1 – Navigation, Delegation, Profile, CV

Partie 2 Study Site Profile, REBs

Partie 3 Documents and other activities