Launch of New Shared Clinical Research Tools
CATALIS and its network of public and private partners have facilitated the implementation of new shared tools designed to optimize the launching and conducting of clinical trials in Quebec; more specifically, CATALIS has coordinated the revision of documents serving to optimize the contract negotiation process with private industry and a memo which serves to clarify the use of form FDA 1572.
New processes recommended to expedite research contract negotiations with Quebec institutions
On May 9, 2022 Quebec’s Ministry of Health and Social Services (Ministère de la santé et des services sociaux or MSSS) announced the release of a new version of the document entitled Clinical research conducted by private entities acting as sponsors: Statement on optimizing the contract negotiation process
The Statement aims to optimize and expedite the contract negotiation process between health and social services network (RSSS) institutions and private industry for the conduct of clinical trials. It is intended for pharmaceutical companies who want to conduct, in collaboration with RSSS institutions, clinical trials that they sponsor. More specifically, 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 which must be considered when negotiating clinical research contracts, namely clinical trial agreements and confidential disclosure agreements.
At the same time, the MSSS also released a new version of the Guide to Best Practice for Clinical Research Contracts with Private Sector Sponsors which is exclusively available to RSSS institutions. The Guide is a reference, information, and support tool for revising pharmaceutical clinical research trial contracts and intended for use by RSSS institutions.
CATALIS Quebec is proud to have coordinated the revision of the Statement, the Guide, and various standard contracts; we hope that the recommendations contained in the Guide will facilitate research agreement evaluations and expedite the launch of your members’ clinical trials in Quebec.
Download the Statement :
Memo to clarify the use of form FDA 1572 in Quebec
This new memo is intended for sponsors and aims to clarify the requirements for the signing of form FDA 1572 in Quebec as applicable to clinical trials to maximize the compliance .
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.
This memo outlines two specific cases in which qualified researchers at sites located within the Quebec health and social services network no longer sign FDA 1572 forms.
Download the memo for sponsors :