Resources

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:

Already 5 Impressive Results

• A First Successful Pilot Project for CATALIS’ New FAST TRACK Evaluation Service: 4 Quebec Institutions Ranked in the Top 5 of the World’s Fastest Sites

Excerpt:
“The FAST TRACK evaluation service’s first pilot project is a tangible benefit resulting from our life sciences-focused efforts and our government’s strategy to attract more clinical trials and private investment to Quebec. The CATALIS network proves that it is possible to be innovative in a highly competitive international environment. We are proud to support its efforts to position Quebec on the world stage of clinical research.” – Pierre Fitzgibbon, Quebec’s Minister of the Economy and Innovation

“I am very impressed by Quebec’s determination and the ability of the various stakeholders to work together to develop one of the most innovative clinical trial implementation models in the world. The speed and effectiveness of clinical trials are critical to addressing the urgent need for patients to be able to access lifesaving, innovative treatments. In the case of cardiovascular disease, this is a global issue that we are fighting. I am delighted that Novartis was the first company to experience this new service, and I look forward to further collaboration with Quebec’s health institutions.” – Christian Macher, Novartis Canada Country President.

• Two New Projects Successfully Authorized Within Seven Weeks Thanks to CATALIS QUEBEC’S FAST TRACK Evaluation Service – CATALIS

Excerpt : 
“The FAST TRACK process in Quebec has demonstrated a strong commitment to revolutionize the clinical trial start up process with the aim to accelerate clinical development and expedite access to innovative medicines for patients.  Boehringer Ingelheim Canada Ltd. is excited to see the success of the Quebec-based FAST TRACK service, which is an important collaboration endeavor that places the province in a favorable position globally to attract clinical research, and especially early clinical research.” – Gabriel Kim, Vice President, medical and regulatory affairs, BI Canada Ltd.

• Roche Pharmaceutical Company’s First Clinical Trial Approved Through CATALIS Quebec’s FAST TRACK Evaluation Service

Excerpt :

“I was thrilled to learn that we were able to significantly reduce the ProHer multi-centre study’s authorization time thanks to CATALIS’ FAST TRACK evaluation service. In a world where patient recruitment is competitive, the opportunity to join forces with our institutions to speed up our timeframes means that Canadian patients have the opportunity to access innovative treatments through our clinical trials. We are working to achieve better outcomes for even more patients, and the FAST TRACK evaluation service is an essential component which allows us to fulfill our organization’s ambition.” –  Christina Archer, Former Clinical Operations Portfolio Leader, Hoffmann-La-Roche

• Sanofi Pharmaceutical Company’s First Clinical Trial Approved Through CATALIS Quebec’s FAST TRACK Evaluation Service

Excerpt :

“Our first experience with CATALIS’ FAST TRACK evaluation service was a huge success. For a Phase I trial in oncology, we reduced our average launch time by two-thirds and attained two global ‘firsts’: the first site to be launched and the first preselected patient! We look forward to future victories and even faster launches with CATALIS.” – Stéphanie Veyrun-Manetti, Sanofi Canada General Manager, Specialty Care and Country Lead, Canada

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.

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

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.

Note:
The ministerial document ” Clinical Research Conducted by a Private Sector Sponsor: Statement on Optimizing the Contract Negotiation Process ” has been temporarily withdrawn to make adjustments, including to
1. include new clarifications related to the Quebec Official and Common Language Act, French (formerly Bill 96) in a contractual context; and
2. remove the section on the Public Registry of Clinical Trials as it has not yet been implemented in Quebec.

Despite the temporary withdrawal of the document, you can download the contract templates that are accepted (as is) by the institutions of the Quebec health and social services network:
• Provincial Model Confidentiality Agreement (mCDA)
• French version
• English version
• Pan-Canadian Clinical Trial Agreement Template (mCTA) v8 from the Canadian Clinical Trials Coordinating Centre (CCTCC)

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.com.

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

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.