CATALIS develops simple, efficient tools whose aim is to maximize the performance of Quebec institutions in conducting clinical trials.

The Nagano Data Processing System

CATALIS and its collaborators undertook the optimization of the Nagano data processing system used by the public institutions of Quebec’s health and social service network in order to provide a multipurpose platform for planning and managing clinical trials.

This section presents CATALIS’ objectives and projects.

To facilitate the administrative management of multicentre ethics reviews

To provide automated data collection of institutions’ performance indicators for clinical trials

To provide the industry with direct access to Nagano and to facilitate communication between the industry and institutions

Pending


To optimize the Nagano PLUS module (CTMS) for budget management and invoicing for clinical trials

Pending


Collaborators

Semi Solutions Médicales, the Ministère de la Santé et des Services Sociaux du Québec (MSSS), the Centre Hospitalier de l’Université de Montréal (CHUM), the Centre Hospitalier Universitaire Sainte-Justine, the McGill University Health Centre (MUHC), the Centre Hospitalier Universitaire de Québec – Université Laval, the Centre Hospitalier Universitaire de Sherbrooke (CHUS), as well as the pharmaceutical members of CATALIS Québec.

Standard operating procedures (SOPs)

CATALIS and its collaborators are finalizing the adaptation to the Quebec policies of the second version of N2 Canada’s SOPs for Research Ethics Boards (REBs).

This new version will be available shortly in both French and English.

Access SOPs (Fr)Access SOPs (En)

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


Collaborators

N2 Canada Network of Networks and the REBs of the Centre hospitalier de l’Université de Montréal (CHUM), the Centre hospitalier universitaire Sainte-Justine (CHU Sainte-Justine) and the McGill University Health Centre (MUHC).

These documents have been adopted by these institutions:

Please let us know if your institution adopts these standard operating procedures: dlaberge@catalisquebec.com

Informed Consent Forms (ICFs)

CATALIS and its collaborators reviewed the standard clauses of the informed consent forms (ICFs) so that they meet new Quebec and international regulations. 

Standard legal clauses for information and consent forms for clinical trials:

English / French


Collaborators

the Ministère de la Santé et des Services Sociaux du Québec (MSSS), the Fonds de Recherche du Québec – Santé (FRQS), the research ethics boards (REBs) of the Centre Hospitalier de l’Université de Montréal (CHUM), the Centre Hospitalier Universitaire Sainte-Justine, the McGill University Health Centre (MUHC), the Centre Hospitalier Universitaire de Québec – Université Laval and the Centre Hospitalier Universitaire de Sherbrooke (CHUS), as well at the pharmaceutical members of CATALIS Québec.

These documents have been adopted by these institutions: Pending

Contracts – Reference price list for clinical trials

In May 2021, the CATALIS Public-Private Network finalized the 2.0 version of the reference price list, which serves to accelerate budget negotiations and compare Quebec’s competitiveness with other Canadian provinces. This list of reference prices is based on the world’s largest reference database, which is used by pharmaceutical companies’ budgeting teams to ensure accurate subsidy projections and allow fair market value negotiations.

The reference price list’s v2.0 has been integrated into Nagano’s new PLUS (CTMS) module platform.

For additional information: dlaberge@catalisquebec.com

Contracts – Facilitating legal reviews

In October 2020, the CATALIS Public-Private Network finalized the revision of three documents serving to facilitate and accelerate the evaluation of research contracts with the private sector:

  • A best practices guide for clinical research contracts with private companies acting as promoters (exclusively for health and social services institutions in Quebec)
  • A statement of principles on optimizing the process of negotiating clinical research contracts with private sector sponsors (for sponsors)
  • A provincial confidential disclosure agreement (mCDA) template

These documents are currently under review and awaiting ministerial approval.

For additional information: dlaberge@catalisquebec.com