Resources for sponsors

The standard clauses include information that must be found in the information and consent forms (ICFs) to comply with the standardization and regulatory requirements in effect in Quebec when carrying out clinical trials. This standardization stems from a consensus of the Research Ethics Boards (REB) of Santé Québec institutions that are members of the CATALIS QUEBEC Network in order to ensure decision-making consistency across the network.

The other harmonized clauses propose common wording used by REBs, in particular in relation to:

• the secondary use of study data; and

• the use of third-party service providers, connected devices and/or applications

Their use in clinical trial consent forms facilitates the drafting of these documents and fast tracks their approval by the institutions part of the health and social services network.

This statement developed by the CATALIS Network and released by the Ministère de la Santé et des Services sociaux confirms the regulatory requirements applicable to institutions part of the health and social services network, as well as the new provisions of the Charter of the French Language.

The Provincial Model Confidentiality Agreement developed by the CATALIS Network and released by the Ministère de la santé et des services sociaux is recommended to expedite the signing of confidentiality agreements between sponsors and institutions part of the healthcare system. If a sponsor submits this contract in its original form without any modifications, public health institutions in Quebec will accept it as is.

The Pan-Canadian Model Clinical Trial Agreement was developed based on the pan-Canadian model of the Canadian Clinical Trials Coordinating Centre (CCTCC) which the CATALIS Network adapted to the Quebec regulatory context. The provincial mCTA was released by the Ministère de la santé et des services sociaux to expedite the signing of clinical trial agreements between sponsors and institutions part of the healthcare system. If a sponsor submits that mCTA in its original form without any modifications, public health institutions in Quebec will accept it as is.

This document drawn up by the CATALIS Network defines criteria for determining which drugs and procedures can be considered “direct research costs.” Its purpose is to support budget negotiations by providing a shared evaluation framework.

This memo drawn up by the CATALIS Network clarifies the stakeholders’ responsibilities with respect to activities carried out in participants’ homes.

This document drawn up by the CATALIS Network clarifies the impact of the merger of health and social services institutions resulting from the creation of Santé Québec on the negotiation, conclusion and signing of new contracts. It also clarifies the naming of institutions, as approved by Santé Québec, which must be used in all agreements signed since December 1, 2024.

This document is intended to support sponsors and healthcare institutions within Quebec’s health and social services network in the use of software and other technologies in clinical trials. It outlines the applicable responsibilities, clarifies legal and contractual obligations, and provides recommendations to help adapt and standardize contractual practices.

This questionnaire drawn up by the CATALIS Network was designed to expedite the authorization of a research project by providing the research pharmacy with the detailed information needed for its feasibility assessment, in addition to the study documents. It must be completed by the sponsor and submitted by the research teams for evaluation.